13 Cgmp jobs in the United States
cGMP Cleaning Technician
21701 Frederick, Maryland
Frederick National Laboratory for Cancer Research
Posted 3 days ago
Job Viewed
Job Description
cGMP Cleaning Technician
Job ID: req4379
Employee Type: nonexempt full-time
Division: Vaccine Clinical Materials Program
Facility: G-Way: Other
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Candidates with these desired skills will be given preferential consideration:
Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here
36,000.00 - 61,875.00 USD
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions
Job ID: req4379
Employee Type: nonexempt full-time
Division: Vaccine Clinical Materials Program
Facility: G-Way: Other
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
- Work each day from 4:00 am to 12:30 pm.
- Be responsible for cleaning throughout the facility to include clean rooms, laboratories, restrooms, warehouse and other areas as needed to maintain and conform to FDA and cGMP guidelines and regulations for cleaning practices - cGMP training and training on specialized equipment will be provided.
- Maintain clean room environment below alert limits by following established cleaning practices.
- Clean and wash walls, ceilings, windows (inside and outside) and screens, equipment exteriors, carts, tables, chairs, stools, benches, door handles, door push plates, door latch releases, light switches, telephones, floors, and locker rooms following established aseptic techniques and using appropriate solutions.
- Be responsible for the preparation of solutions, solution disposal, trash disposal and water collection.
- Clean administrative and laboratory areas, including vacuuming rugs and removing stains and foreign matter from a variety of surfaces using proper cleaners.
- Move office furniture and equipment for cleaning.
- Sweep, mop, strip, scrub, wax, and polish floors using industrial power equipment.
- Wash and clean windows and ceiling air vents.
- Dust and clean office areas, woodwork, furniture, floor coverings, fixtures, stairwells, fire doors, and empty trash containers.
- Dispose of biological waste materials.
- Clean and disinfect restrooms, replenish paper supplies.
- Provide general cleanup outside of buildings.
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a high school degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, must have 2 years of experience.
- Must possess basic Microsoft Office skills.
- Ability to work in a BL2 lab.
- Ability to pass aseptic gowning validation.
- Ability to work in an environment with potential exposure to particulates, vapors or noise and ability to wear a full-face respirator.
- Ability to operate industrial power equipment used for cleaning.
- Ability to perform physical duties including lifting and carrying up to 50 lbs. Walking, standing, climbing stairs, bending, stooping, and working in confined areas.
- Ability to read and understand written instructions and follow SOPs.
- Experience with cGMP guidelines and regulations for cleaning practices.
- Ability to adhere to regulatory requirements.
- Ability to write legibly and error free to accurately document solutions prep and cleaning activities into logbooks.
- Good time management skills.
- Good communication skills and work ethic.
- Ability to follow instructions and work effectively with a team.
- Ability to obtain and maintain a security clearance.
- Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, carry up to 50lb, lift >50lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods. (BP)
- Ability to obtain confined space certification.
- Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
- Ability to wear Personal Protective Equipment (PPE).
- Ability to Enter a Laboratory or Encounter a Hazardous Area.
- Ability to Kneel.
- Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas.
- Pacemakers are prohibited.
- Repeated bending.
- Exposure to temperatures below 32 degrees indoors for small amounts of time.
- Exposure to temperatures above 90 degrees indoors for small amounts of time.
Candidates with these desired skills will be given preferential consideration:
- Knowledge of proper waxes, strippers, polishes, and stain removers required to clean assigned areas.
- Experienced in industrial or cGMP cleaning practices and familiarity with chemicals used for cGMP cleaning.
- Solid work history.
- Accreditations or certifications related to cleaning.
- This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance.
- This position is subject to working with or have potential for exposure to
infectious material, requiring medical clearance and immunizations.
Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here
36,000.00 - 61,875.00 USD
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions
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0
cGMP Cleaning Technician
21701 Frederick, Maryland
BioSpace, Inc.
Posted 3 days ago
Job Viewed
Job Description
Job Details
cGMP Cleaning Technician
Job ID: req4379
Employee Type: nonexempt full-time
Division: Vaccine Clinical Materials Program
Facility: G-Way: Other
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Candidates with these desired skills will be given preferential consideration:
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here
36,000.00 - 61,875.00 USD
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions
Company
A rewarding career with global impact
Whether you're an expert in your field or just starting out, we have a career opportunity for you. We're always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
Company info
Website Phone Location 8560 Progress Drive
Frederick
MD
21701
United States
Share this job
cGMP Cleaning Technician
Job ID: req4379
Employee Type: nonexempt full-time
Division: Vaccine Clinical Materials Program
Facility: G-Way: Other
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
- Work each day from 4:00 am to 12:30 pm.
- Be responsible for cleaning throughout the facility to include clean rooms, laboratories, restrooms, warehouse and other areas as needed to maintain and conform to FDA and cGMP guidelines and regulations for cleaning practices - cGMP training and training on specialized equipment will be provided.
- Maintain clean room environment below alert limits by following established cleaning practices.
- Clean and wash walls, ceilings, windows (inside and outside) and screens, equipment exteriors, carts, tables, chairs, stools, benches, door handles, door push plates, door latch releases, light switches, telephones, floors, and locker rooms following established aseptic techniques and using appropriate solutions.
- Be responsible for the preparation of solutions, solution disposal, trash disposal and water collection.
- Clean administrative and laboratory areas, including vacuuming rugs and removing stains and foreign matter from a variety of surfaces using proper cleaners.
- Move office furniture and equipment for cleaning.
- Sweep, mop, strip, scrub, wax, and polish floors using industrial power equipment.
- Wash and clean windows and ceiling air vents.
- Dust and clean office areas, woodwork, furniture, floor coverings, fixtures, stairwells, fire doors, and empty trash containers.
- Dispose of biological waste materials.
- Clean and disinfect restrooms, replenish paper supplies.
- Provide general cleanup outside of buildings.
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a high school degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, must have 2 years of experience.
- Must possess basic Microsoft Office skills.
- Ability to work in a BL2 lab.
- Ability to pass aseptic gowning validation.
- Ability to work in an environment with potential exposure to particulates, vapors or noise and ability to wear a full-face respirator.
- Ability to operate industrial power equipment used for cleaning.
- Ability to perform physical duties including lifting and carrying up to 50 lbs. Walking, standing, climbing stairs, bending, stooping, and working in confined areas.
- Ability to read and understand written instructions and follow SOPs.
- Experience with cGMP guidelines and regulations for cleaning practices.
- Ability to adhere to regulatory requirements.
- Ability to write legibly and error free to accurately document solutions prep and cleaning activities into logbooks.
- Good time management skills.
- Good communication skills and work ethic.
- Ability to follow instructions and work effectively with a team.
- Ability to obtain and maintain a security clearance.
- Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, carry up to 50lb, lift >50lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods. (BP)
- Ability to obtain confined space certification.
- Visual acuity to include depth perception, color distinction, and vision correctable to 20/40.
- Ability to wear Personal Protective Equipment (PPE).
- Ability to Enter a Laboratory or Encounter a Hazardous Area.
- Ability to Kneel.
- Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas.
- Pacemakers are prohibited.
- Repeated bending.
- Exposure to temperatures below 32 degrees indoors for small amounts of time.
- Exposure to temperatures above 90 degrees indoors for small amounts of time.
Candidates with these desired skills will be given preferential consideration:
- Knowledge of proper waxes, strippers, polishes, and stain removers required to clean assigned areas.
- Experienced in industrial or cGMP cleaning practices and familiarity with chemicals used for cGMP cleaning.
- Solid work history.
- Accreditations or certifications related to cleaning.
- This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance.
- This position is subject to working with or have potential for exposure to
infectious material, requiring medical clearance and immunizations.
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here
36,000.00 - 61,875.00 USD
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions
Company
A rewarding career with global impact
Whether you're an expert in your field or just starting out, we have a career opportunity for you. We're always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
Company info
Website Phone Location 8560 Progress Drive
Frederick
MD
21701
United States
Share this job
View Now
1
Senior cGMP Specialist - Cyclotron
77246 Houston, Texas
Houston Methodist
Posted today
Job Viewed
Job Description
Sr. Current Good Manufacturing Practices (cGMP) Specialist
At Houston Methodist, the Sr. Current Good Manufacturing Practices (cGMP) Specialist is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP regulations pertaining to the manufacture of therapeutics and devices. Additionally, this position will be responsible for all aspects of compliance associated with the quality operations including, but not limited to, review of procedures, verification of equipment and facility cleanliness, proper gowning, correct material labelling, correct operating parameters for equipment and proper execution of protocols in accordance with approved SOPs and the proper guidance of junior level team members. As a senior member of the department, this position will actively contribute to the development of policies and procedures for the delivery of novel products to our patients and customers.
Houston Methodist Experience Expectations:
- Provide personalized care and service by consistently demonstrating our I CARE values:
- Integrity: We are honest and ethical in all we say and do.
- Compassion: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
- Accountability: We hold ourselves accountable for all our actions.
- Respect: We treat every individual as a person of worth, dignity, and value.
- Excellence: We strive to be the best at what we do and a model for others to emulate.
- Practices the Caring and Serving Model
- Delivers personalized service using HM Service Standards
- Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
- Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience
- Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
- Actively supports the organization's vision, fulfills the mission and abides by the I CARE values
- Provides work direction of authorized core users working in either production or quality control.
- Collaborates with cross-functional teams including research, process development, quality assurance and quality control.
- Works with research team members to assist them with transitioning their research processes to compliant cGMP SOP's and participates in multi-functional project teams as necessary
- Participates in internal audits and external inspections by Regulatory Agencies and reports findings to direct management.
- Responds to calls/alarms off hours and weekends for facility systems and equipment failures.
- Serves as technical subject matter expert in support of department functions.
- Reviews testing documentation from all cross-functional departments
- Ensures development, pre-clinical and clinical product supply are executed effectively against changing demand schedule and meet quality requirements.
- Conducts internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures.
- Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks
- Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies.
- Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs.
- Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.
- Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development.
- Identifies opportunities for improvement and leads projects which result in innovative solutions that increase the level of compliance and efficiency of the team.
- Bachelor of Arts or Science degree
- Master's degree preferred
- Five years of biotechnology or pharmaceutical industry experience with exposure to cGMP manufacturing operations
- Experience performing equipment validation (IQ/OQ/PQ), facility commissioning, internal/ external audits, batch record review and hosting regulatory inspections preferred
- N/A
- Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
- Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
- Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
- Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and cGMP auditing procedures
- Proficiency in spreadsheet, word processing and presentation software
- Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented
- Knowledge of regulations applicable to drugs and devices (21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them based on the phase of the project (GLP, Phase I, PhaseII/III etc.)
- Ability to mentor and coach department personnel
- Demonstrates highly effective communication skills and the ability to lead both informal/formal educational sessions to include classroom/seminar instruction in cGMPs and specialized topics related to compliance and best practices
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.
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2
cGMP Quality Support Specialist
30383 Atlanta, Georgia
Allyon, Inc.
Posted 9 days ago
Job Viewed
Job Description
cGMP Quality Support Specialist
Job Details
Location : Atlanta, GA
Position Contact : Tyler Pettway
Job Number : 32074
Job Posted Date : 8/27/2025
Job Description
Job Title:
cGMP Quality Support Specialist
Location :
Atlanta, GA
Minimum Requirements:
• Bachelor's Degree or equivalent plus the following:
• A minimum five (5) years of quality control/quality assurance experience in the pharmaceutical industry providing oversight to QC/QA tasks/projects and other cGMP oversite responsibilities.
• Expertise in maintaining regulatory compliance-including during PHE responses-with cGMP, inventory systems validation, FDA regulatory guidance, and 21 CFR (Parts 11, 210, 211, 600 and 800)
• Knowledge of FDA and industry standard cGMP related guidance and quality management principles.
• Strong knowledge of relevant FDA regulatory guidance.
• Physical Demands / Surroundings - The duties of this position may require the individual to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds.
Duties & Responsibilities:
• Maintain a comprehensive quality control program to ensure that cGMP standards and other regulatory guidelines are adhered to by SNS staff, during the receipt, storage, handling, transport, and distribution of pharmaceutical products.
• Monitor all quality assurance aspects of the program and recommends program modifications or revisions when necessary.
• Conduct audits of SNS facilities, on a regular basis, to document cGMP compliance and identify deficiencies.
• Review facility data and documentation to ensure all quality assurance requirements are in place, controlled, and meet cGMP and other regulatory requirements.
• Investigate deviations which pose a significant risk of adversely impacting products, determine the cause of the problem and develops corrective and preventive actions.
• Maintain an interpersonal relationship with program officials, key staff within ASPR, HHS, other Federal agencies, key contract partner representatives, members of the science-based academic community, to resolve any issues with the quality control programs.
• Serve as a member of the Quality Control Unit (QCU) jointly responsible for ensuring compliance with applicable current go cGMPs for the storage and transportation of finished pharmaceuticals.
• Develop audit plans and establish cGMP audit criteria; assess deficiencies and/or discrepancies and suggest/implement corrective action as needed to maintain cGMP/FDA compliance. Report compliance deficiencies to management as required.
• Analyze and evaluate internal cGMP controls, policies and procedures. Propose recommendations and provide support for cases of non-compliance, missing policies, lack of controls, and other operational improvements. Assist in writing SOPs and protocols where applicable, and provides quality control and regulatory expertise.
• Prepare audit and control reports by collecting, analyzing, and summarizing information and trends.
• Ensure compliance with established internal cGMP control procedures by examining records, reports, operating practices, and documentation. Coordinate and conduct periodic internal audits as well as audits of contract partners.
• Assist and assure cGMP compliance with applicable regulatory requirements, industry standards, and program Quality System policies. Make continuous improvements to the Quality Systems to execute and implement current Good Manufacturing Practices and to increase system efficiency.
Pay Range:
$20/hr - $21/hr
Summary:
Allyon is a certified woman-owned small business dedicated to empowering cleared IT professionals to reach their career goals and building high-performance teams for our federal government clients nationwide. With over 15 years of experience supporting the federal government, we've proudly helped professionals like you achieve their career goals across all areas of IT. Apply today and become part of our mission to support the nation's most critical technology, infrastructure, and cybersecurity initiatives. Together, we can drive innovation and make a difference where it matters most!
What we offer:
• Competitive pay and benefits
• 401k eligibility after 6 months including company match
Allyon, Inc. is an equal employment opportunities (EEO) employer and terms of employment are without regard to race, color, religion, sex, national origin, age, disability or genetics. Allyon, Inc. complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment.
Job Details
Location : Atlanta, GA
Position Contact : Tyler Pettway
Job Number : 32074
Job Posted Date : 8/27/2025
Job Description
Job Title:
cGMP Quality Support Specialist
Location :
Atlanta, GA
Minimum Requirements:
• Bachelor's Degree or equivalent plus the following:
• A minimum five (5) years of quality control/quality assurance experience in the pharmaceutical industry providing oversight to QC/QA tasks/projects and other cGMP oversite responsibilities.
• Expertise in maintaining regulatory compliance-including during PHE responses-with cGMP, inventory systems validation, FDA regulatory guidance, and 21 CFR (Parts 11, 210, 211, 600 and 800)
• Knowledge of FDA and industry standard cGMP related guidance and quality management principles.
• Strong knowledge of relevant FDA regulatory guidance.
• Physical Demands / Surroundings - The duties of this position may require the individual to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds.
Duties & Responsibilities:
• Maintain a comprehensive quality control program to ensure that cGMP standards and other regulatory guidelines are adhered to by SNS staff, during the receipt, storage, handling, transport, and distribution of pharmaceutical products.
• Monitor all quality assurance aspects of the program and recommends program modifications or revisions when necessary.
• Conduct audits of SNS facilities, on a regular basis, to document cGMP compliance and identify deficiencies.
• Review facility data and documentation to ensure all quality assurance requirements are in place, controlled, and meet cGMP and other regulatory requirements.
• Investigate deviations which pose a significant risk of adversely impacting products, determine the cause of the problem and develops corrective and preventive actions.
• Maintain an interpersonal relationship with program officials, key staff within ASPR, HHS, other Federal agencies, key contract partner representatives, members of the science-based academic community, to resolve any issues with the quality control programs.
• Serve as a member of the Quality Control Unit (QCU) jointly responsible for ensuring compliance with applicable current go cGMPs for the storage and transportation of finished pharmaceuticals.
• Develop audit plans and establish cGMP audit criteria; assess deficiencies and/or discrepancies and suggest/implement corrective action as needed to maintain cGMP/FDA compliance. Report compliance deficiencies to management as required.
• Analyze and evaluate internal cGMP controls, policies and procedures. Propose recommendations and provide support for cases of non-compliance, missing policies, lack of controls, and other operational improvements. Assist in writing SOPs and protocols where applicable, and provides quality control and regulatory expertise.
• Prepare audit and control reports by collecting, analyzing, and summarizing information and trends.
• Ensure compliance with established internal cGMP control procedures by examining records, reports, operating practices, and documentation. Coordinate and conduct periodic internal audits as well as audits of contract partners.
• Assist and assure cGMP compliance with applicable regulatory requirements, industry standards, and program Quality System policies. Make continuous improvements to the Quality Systems to execute and implement current Good Manufacturing Practices and to increase system efficiency.
Pay Range:
$20/hr - $21/hr
Summary:
Allyon is a certified woman-owned small business dedicated to empowering cleared IT professionals to reach their career goals and building high-performance teams for our federal government clients nationwide. With over 15 years of experience supporting the federal government, we've proudly helped professionals like you achieve their career goals across all areas of IT. Apply today and become part of our mission to support the nation's most critical technology, infrastructure, and cybersecurity initiatives. Together, we can drive innovation and make a difference where it matters most!
What we offer:
• Competitive pay and benefits
• 401k eligibility after 6 months including company match
Allyon, Inc. is an equal employment opportunities (EEO) employer and terms of employment are without regard to race, color, religion, sex, national origin, age, disability or genetics. Allyon, Inc. complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment.
View Now
3
Supervisor, cGMP Facility Cleaning
92054 Oceanside, California
Gilead Sciences, Inc.
Posted 1 day ago
Job Viewed
Job Description
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
**Job Description**
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
**Job Description**
Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
We are seeking a highly motivated individual to join our organization as a supervisor for the cGMP Cleaning staff to support Kite's Viral Vector facility in Oceanside, CA. The supervisor will provide 2nd shift cGMP cleaning oversight for our ISO Classrooms and Controlled Non-Classified Lab Areas.
SHIFT: Evening Shift, 4:00pm-12:30am
**Responsibilities**
+ Oversee and perform cleaning operations under strict guidelines for Controlled cleanrooms and GMP laboratory environments.
+ Continually monitor the cleanroom and laboratory cleaning procedures to ensure all cleanings are completed promptly and correctly.
+ Maintains accurate and complete records. Review documentation and logbooks and ensure GMP compliance.
+ Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
+ Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
+ Reviews and provides signatory signoff of documentation. Updates SOPs and FRMs as needed.
+ Responsible for participating in continuous training: cGMP training, technical skills, safety, and performance improvement. Attends and completes all training assigned by Company SOPs, procedures, and policies
+ Maintain training requirements for staff and administer training as needed for new or current staff.
+ Participate in deviation investigations and identify root cause solutions.
+ Perform other tasks/duties as assigned by stakeholders and support other Departments as needed
+ Safety first mindset. Works in a safe and effective manner in accordance with all company, state and federal rules and regulations
**Requirements**
+ Thorough understanding of cGMP facility and laboratory cleaning within a controlled environment including ceilings, walls, equipment, and floors.
+ Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
+ Have an excellent work ethic and demonstrate dependability and timeliness.
+ Ability to read and follow strict Standard Operating Procedures
+ Must be able to work off shift hours, holidays, and weekends as well as on-call rotation.
+ Ability to manage a team and possess the skills to work in a self-guided manner
+ Able to lift and/or move up to 40 pounds.
+ Able to squat, bend, move, and/or reach for about 50% of shift
+ Able to stand, walk, and/or move about for 50% of shift.
**Basic Qualifications:**
+ Bachelor's degree with 2+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience OR
+ High School Degree with 4+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience
**Preferred Qualifications:**
+ 4+ years of clean room sanitization experience or cGMP operational experience
+ 4+ years of Supervisory Experience Ability to work in a clean room environment where Biohazardous wastes are handled and removed daily.
+ Ability to lead a team across multiple shifts
+ Work ethic and demonstrate dependability and timeliness
+ Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
+ Detail oriented, excellent Good Documentation Practices
+ Comfortable in a passionate company environment with minimal direction and able to adjust workload based upon changing priorities
The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
**Job Description**
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
**Job Description**
Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team.
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
We are seeking a highly motivated individual to join our organization as a supervisor for the cGMP Cleaning staff to support Kite's Viral Vector facility in Oceanside, CA. The supervisor will provide 2nd shift cGMP cleaning oversight for our ISO Classrooms and Controlled Non-Classified Lab Areas.
SHIFT: Evening Shift, 4:00pm-12:30am
**Responsibilities**
+ Oversee and perform cleaning operations under strict guidelines for Controlled cleanrooms and GMP laboratory environments.
+ Continually monitor the cleanroom and laboratory cleaning procedures to ensure all cleanings are completed promptly and correctly.
+ Maintains accurate and complete records. Review documentation and logbooks and ensure GMP compliance.
+ Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
+ Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
+ Reviews and provides signatory signoff of documentation. Updates SOPs and FRMs as needed.
+ Responsible for participating in continuous training: cGMP training, technical skills, safety, and performance improvement. Attends and completes all training assigned by Company SOPs, procedures, and policies
+ Maintain training requirements for staff and administer training as needed for new or current staff.
+ Participate in deviation investigations and identify root cause solutions.
+ Perform other tasks/duties as assigned by stakeholders and support other Departments as needed
+ Safety first mindset. Works in a safe and effective manner in accordance with all company, state and federal rules and regulations
**Requirements**
+ Thorough understanding of cGMP facility and laboratory cleaning within a controlled environment including ceilings, walls, equipment, and floors.
+ Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees)
+ Have an excellent work ethic and demonstrate dependability and timeliness.
+ Ability to read and follow strict Standard Operating Procedures
+ Must be able to work off shift hours, holidays, and weekends as well as on-call rotation.
+ Ability to manage a team and possess the skills to work in a self-guided manner
+ Able to lift and/or move up to 40 pounds.
+ Able to squat, bend, move, and/or reach for about 50% of shift
+ Able to stand, walk, and/or move about for 50% of shift.
**Basic Qualifications:**
+ Bachelor's degree with 2+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience OR
+ High School Degree with 4+ years of operations and/or pharmaceutical / biotechnology and/or manufacturing experience
**Preferred Qualifications:**
+ 4+ years of clean room sanitization experience or cGMP operational experience
+ 4+ years of Supervisory Experience Ability to work in a clean room environment where Biohazardous wastes are handled and removed daily.
+ Ability to lead a team across multiple shifts
+ Work ethic and demonstrate dependability and timeliness
+ Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
+ Detail oriented, excellent Good Documentation Practices
+ Comfortable in a passionate company environment with minimal direction and able to adjust workload based upon changing priorities
The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .
**For jobs in the United States:**
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
View Now
4
cGMP Quality Assurance Manager
70806 Baton Rouge, Louisiana
Honeywell
Posted 1 day ago
Job Viewed
Job Description
The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards. The GMP QA Manager also monitors Contract Manufacturing Organizations (CMOs) ensuring compliance of the manufacturing, packaging and analytical testing of pharmaceutical dosage forms and drug substances. They also identify risks and deficiencies, which they communicate to cross functional teams and management.
**Essential Duties and Responsibilities:**
Following is a summary of the essential functions for this job. Other duties may be added and performed, which are not mentioned below. Specific activities may change from time to time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ Ensures cGMP analytical activities, such as analytical methods, test results and Certificates of Analysis (CoA), Batch Records comply with internal SOPs, company policies and procedures, safety and environmental and regulatory requirements
+ Reviews cGMP batch manufacturing and packaging records and provides recommendations for approval/rejection and disposition
+ Manages and approves cGMP investigations, quality incidents, deviations, CAPAs, change control and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness
+ Assists with development and implementation of cGMP compliant systems, including internal SOPs, forms, and work instructions
+ Performs Independent audits for compliance to policies and procedures: on paper vs. practice
+ Assists corporate quality group in preparation of internal quality audit programs and conducts internal audits per approved schedules in accordance with pertinent quality documents; prepares all corresponding documents and reports
+ Leads all external cGMP audits of vendors, including US and International cGMP, GLP, GDP vendor audits, as needed
+ Coordinates annual and ongoing cGMP training
+ Acts as a primary contact for cGMP regulatory inspections
+ Oversees release of commercial product
+ Maintains the quality function for drug products, including but not limited to:
+ Manages and reviews Product Complaints and Recall program for EU and US products
+ Releases or rejects intermediates for use outside of the control of the manufacturing company
+ Establishes a system to release or reject raw materials, intermediates, packaging and labeling materials; Well versed with IPEC, ICH Q7, 21 CFR 210/211 and Eudralex volume 4 Good Manufacturing Practice (GMP) guidelines
+ Reviews unexecuted and completed batch production and laboratory control records of critical process steps before release of drug products
+ Reviews and monitors release and stability data
+ Reviews and approves changes that potentially impact quality of intermediates, drug products
+ Reviews and approves validation protocols and reports, Specifications, certificates of analysis (CoAs), release of raw materials, and product disposition
+ Approves selection of contract manufacturers for intermediates, drug products
+ Approves all specifications and master production instructions
+ Approves all procedures impacting the quality of intermediates, drug products
+ Ensures effective systems are used for maintaining and calibrating critical equipment
+ Ensures materials are appropriately tested and the results are reported
+ Ensures there is stability data to support retest or expiry dates and storage conditions on drug products, and intermediates where appropriate; performs product quality reviews
+ Manages and maintain mock recall procedures and policies
+ Develops with the CMC team and CMOs: drug substances (DSs), drug products (DPs), key raw material and intermediates specifications and stability requirements, master batch records, validated manufacturing processes and analytical methods, and CTM and commercial packaging and labeling
+ Work closely with internal and external departments to assure compliance with cGMP quality systems and regulations issued by the FDA, and other applicable regulatory bodies
"In October, 2024 Honeywell announced the spin-off of our Advanced Materials business to become a stand-alone publicly traded company, independent of Honeywell. Our intention is that this role, dedicated to the Advanced Materials business, will be a part of this future transaction when the separation occurs."
**Must Have**
+ Auditing experience in a GMP and GCP environment
+ Excipient cGMP production and quality assurance experience
+ Knowledge of US, EMA, NMPA, PMDA, HC, and ICH regulations, guidance and industry standards for CMC, GMP and GCP
+ 10 + years in pharmaceutical Quality Assurance
**We Value**
+ BA or BS degree in a scientific discipline preferred, or comparable experience
+ Previous experience of manufacturing and/or analytical testing is a plus
+ Proficiency using Office 365, LIMS, SCICORD, SAP, Adobe Acrobat (standard), DYMO labeler, Adobe Acrobat (standard), and various internet browsers
+ Ability to travel, including overnight
Honeywell helps organizations solve the world's most complex challenges in automation, the future of aviation and energy transition. As a trusted partner, we provide actionable solutions and innovation through our Aerospace Technologies, Building Automation, Energy and Sustainability Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable.
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.
**Essential Duties and Responsibilities:**
Following is a summary of the essential functions for this job. Other duties may be added and performed, which are not mentioned below. Specific activities may change from time to time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ Ensures cGMP analytical activities, such as analytical methods, test results and Certificates of Analysis (CoA), Batch Records comply with internal SOPs, company policies and procedures, safety and environmental and regulatory requirements
+ Reviews cGMP batch manufacturing and packaging records and provides recommendations for approval/rejection and disposition
+ Manages and approves cGMP investigations, quality incidents, deviations, CAPAs, change control and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness
+ Assists with development and implementation of cGMP compliant systems, including internal SOPs, forms, and work instructions
+ Performs Independent audits for compliance to policies and procedures: on paper vs. practice
+ Assists corporate quality group in preparation of internal quality audit programs and conducts internal audits per approved schedules in accordance with pertinent quality documents; prepares all corresponding documents and reports
+ Leads all external cGMP audits of vendors, including US and International cGMP, GLP, GDP vendor audits, as needed
+ Coordinates annual and ongoing cGMP training
+ Acts as a primary contact for cGMP regulatory inspections
+ Oversees release of commercial product
+ Maintains the quality function for drug products, including but not limited to:
+ Manages and reviews Product Complaints and Recall program for EU and US products
+ Releases or rejects intermediates for use outside of the control of the manufacturing company
+ Establishes a system to release or reject raw materials, intermediates, packaging and labeling materials; Well versed with IPEC, ICH Q7, 21 CFR 210/211 and Eudralex volume 4 Good Manufacturing Practice (GMP) guidelines
+ Reviews unexecuted and completed batch production and laboratory control records of critical process steps before release of drug products
+ Reviews and monitors release and stability data
+ Reviews and approves changes that potentially impact quality of intermediates, drug products
+ Reviews and approves validation protocols and reports, Specifications, certificates of analysis (CoAs), release of raw materials, and product disposition
+ Approves selection of contract manufacturers for intermediates, drug products
+ Approves all specifications and master production instructions
+ Approves all procedures impacting the quality of intermediates, drug products
+ Ensures effective systems are used for maintaining and calibrating critical equipment
+ Ensures materials are appropriately tested and the results are reported
+ Ensures there is stability data to support retest or expiry dates and storage conditions on drug products, and intermediates where appropriate; performs product quality reviews
+ Manages and maintain mock recall procedures and policies
+ Develops with the CMC team and CMOs: drug substances (DSs), drug products (DPs), key raw material and intermediates specifications and stability requirements, master batch records, validated manufacturing processes and analytical methods, and CTM and commercial packaging and labeling
+ Work closely with internal and external departments to assure compliance with cGMP quality systems and regulations issued by the FDA, and other applicable regulatory bodies
"In October, 2024 Honeywell announced the spin-off of our Advanced Materials business to become a stand-alone publicly traded company, independent of Honeywell. Our intention is that this role, dedicated to the Advanced Materials business, will be a part of this future transaction when the separation occurs."
**Must Have**
+ Auditing experience in a GMP and GCP environment
+ Excipient cGMP production and quality assurance experience
+ Knowledge of US, EMA, NMPA, PMDA, HC, and ICH regulations, guidance and industry standards for CMC, GMP and GCP
+ 10 + years in pharmaceutical Quality Assurance
**We Value**
+ BA or BS degree in a scientific discipline preferred, or comparable experience
+ Previous experience of manufacturing and/or analytical testing is a plus
+ Proficiency using Office 365, LIMS, SCICORD, SAP, Adobe Acrobat (standard), DYMO labeler, Adobe Acrobat (standard), and various internet browsers
+ Ability to travel, including overnight
Honeywell helps organizations solve the world's most complex challenges in automation, the future of aviation and energy transition. As a trusted partner, we provide actionable solutions and innovation through our Aerospace Technologies, Building Automation, Energy and Sustainability Solutions, and Industrial Automation business segments - powered by our Honeywell Forge software - that help make the world smarter, safer and more sustainable.
Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.
View Now
5
Manufacturing Engineer (CGMP Or ISO)
20851 Rockville, Maryland
Actalent
Posted 1 day ago
Job Viewed
Job Description
Job Title: Manufacturing EngineerJob Description
Join a dynamic multidisciplinary team dedicated to the research and development of innovative high-volume manufacturing methods for consumables, crucial for high-reliability applications. This role involves guiding the design process to ensure scalability and quality, while employing the most appropriate manufacturing methods.
Responsibilities
+ Guide the design process of consumables for scalability and quality.
+ Develop and prototype systems for consumable manufacturing and inspection.
+ Make key technical decisions throughout research and development activities.
+ Engage in hands-on work during active experimental programs.
+ Prepare and present project designs and technical reports.
+ Create and update manufacturing and project documents and procedures.
+ Collaborate with Quality to ensure compliance with manufacturing and assembly guidelines.
+ Ensure adherence to relevant regulatory standards.
Essential Skills
+ Experience with liquid integration manufacturing techniques.
+ Experience with roll-to-roll manufacturing techniques.
+ Experience in high-reliability industries such as automotive, medical device, defense, aerospace, aviation, clinical, etc.
+ Proficiency in lean manufacturing and continuous improvement methodologies.
Additional Skills & Qualifications
+ Bachelor's degree in a Technology field like Engineering, Science, Biotechnology, or related field required; Master's degree preferred.
+ Minimum of 5-10 years of experience in high-volume plastic manufacturing.
+ Experience with cGMP and/or ISO certification preferred.
+ Supervisory experience is a plus.
+ Experience in manufacturing immunoassays, reagents, in-vitro diagnostic devices, and biotech consumables is desirable.
+ Familiarity with manufacturing techniques such as roll-to-roll processing, plastic film and metal foil processing techniques, and coating techniques.
Work Environment
Work in an office environment with opportunities for hands-on experimental work. The company is growing, offering opportunities for advancement within the R&D team. Dress code is business casual.
Job Type & Location
This is a Permanent position based out of Rockville, Maryland.
Pay and Benefits
The pay range for this position is $ - $ /yr.
Ask to send separate- John has the package. Its an annual bonus.
Workplace Type
This is a fully onsite position in Rockville,MD.
Application Deadline
This position is anticipated to close on Oct 11, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
Join a dynamic multidisciplinary team dedicated to the research and development of innovative high-volume manufacturing methods for consumables, crucial for high-reliability applications. This role involves guiding the design process to ensure scalability and quality, while employing the most appropriate manufacturing methods.
Responsibilities
+ Guide the design process of consumables for scalability and quality.
+ Develop and prototype systems for consumable manufacturing and inspection.
+ Make key technical decisions throughout research and development activities.
+ Engage in hands-on work during active experimental programs.
+ Prepare and present project designs and technical reports.
+ Create and update manufacturing and project documents and procedures.
+ Collaborate with Quality to ensure compliance with manufacturing and assembly guidelines.
+ Ensure adherence to relevant regulatory standards.
Essential Skills
+ Experience with liquid integration manufacturing techniques.
+ Experience with roll-to-roll manufacturing techniques.
+ Experience in high-reliability industries such as automotive, medical device, defense, aerospace, aviation, clinical, etc.
+ Proficiency in lean manufacturing and continuous improvement methodologies.
Additional Skills & Qualifications
+ Bachelor's degree in a Technology field like Engineering, Science, Biotechnology, or related field required; Master's degree preferred.
+ Minimum of 5-10 years of experience in high-volume plastic manufacturing.
+ Experience with cGMP and/or ISO certification preferred.
+ Supervisory experience is a plus.
+ Experience in manufacturing immunoassays, reagents, in-vitro diagnostic devices, and biotech consumables is desirable.
+ Familiarity with manufacturing techniques such as roll-to-roll processing, plastic film and metal foil processing techniques, and coating techniques.
Work Environment
Work in an office environment with opportunities for hands-on experimental work. The company is growing, offering opportunities for advancement within the R&D team. Dress code is business casual.
Job Type & Location
This is a Permanent position based out of Rockville, Maryland.
Pay and Benefits
The pay range for this position is $ - $ /yr.
Ask to send separate- John has the package. Its an annual bonus.
Workplace Type
This is a fully onsite position in Rockville,MD.
Application Deadline
This position is anticipated to close on Oct 11, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now
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6
3rd Shift CGMP Biomanufactuirng Training Specialist
08875 Somerset, New Jersey
Abacus
Posted today
Job Viewed
Job Description
Job Title
This position works with Training Manager, cGMP Biomanufacturing to organize and present in-person training sessions on SOPs, cGMP processes, compliance and Environmental Health and Safety to cGMP BioManufacturing Group, assist with developing content and formatting training materials, developing and administering training programs for employees, assesses training and.
View Now
7
Manufacturing Technician - Cleanroom or cGMP Background
60148 Lombard, Illinois
Yoh
Posted today
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Job Description
Manufacturing Technician - Cleanroom or cGMP Background
Category:
Manufacturing & Production
Employment Type:
Contract To Hire
Reference:
BH-
Job Title:
cGMP or Cleanroom Manufacturing Technician
Location:
Lombard, Illinois
Type: Temp-to-HireType:
Schedule:
- 1st Shift:
Monday to Friday, 6:00 AM - 2:30 PM Pay: $19.00/Hr. - 2nd Shift:
Monday to Friday, 2:00 PM - 10:30 PM Pay: $1.00/Hr. - Industry:
Leading Medical Device Diagnostics Manufacturer
Join a world-class medical device diagnostic manufacturer as a cGMP Manufacturing Technician in Lombard, IL. This role supports production operations in a cleanroom environment, ensuring equipment is properly operated, maintained, and sanitized. Ideal candidates will have prior experience in cGMP or cleanroom settings and a strong attention to detail.
Key Responsibilities:
- Operate and monitor production equipment
- Replenish materials and supplies during production
- Prepare equipment and components for manufacturing processes
- Perform cleaning and sanitization of production equipment
- Maintain cleanliness and organization of the production floor
- Stand for extended periods and perform repetitive tasks
- Safely lift and move materials up to 25 pounds
- High School Diploma or GED required
- Prior experience in cGMP and/or cleanroom environments
- Ability to lift up to 25 pounds
- Comfortable with standing for long periods
- Strong work ethic and attention to detail
- Willingness to work in a fast-paced, regulated environment
Estimated Max Rate : 21.00
What's In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice:
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