7 Manufacturing Companies jobs in Budd Lake

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

Janssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Supervisor, QC Release (S-W Day Shift) in Raritan, NJ!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

The QC Supervisor is responsible for overseeing day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. They will also support internal and external audits. They will typically guide daily work activities of 10-12 direct staff within a functional laboratory of the Quality Control department. They are responsible for interviewing, hiring, performance review, rewarding and disciplining employees, addressing complaints, and resolving conflict.

Key Responsibilities:

• Manage analyst schedule to support Drug Product testing
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Review/approve documents as a QC department subject matter expert (SME)
• Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
• Ensure accuracy and completeness of executed analytical method transfer activities
• Set testing priorities and manage work assignments
• Mentor, train, and supervise quality control staff, as well as evaluate performance and provide opportunities for growth
• Communicate department objectives and metrics
• Support internal and Health Authority audits, as well as audit related investigations

Qualifications: Education:

• Minimum of a Bachelor’s or equivalent University degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, or related scientific field is preferred

Experience and Skills:

Required:

• Minimum 6 years of relevant work experience
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Detailed knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards for QC testing

Preferred:

• Proficient knowledge of analytical technologies used in a Quality Control laboratory and method transfer
• Experience leading, coaching, or supervising direct or indirect personnel or teams
• Work experience in Cell and/or Gene Therapy or Biologics
• Experience with LIMs and SAP or equivalent systems

Other:

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 7AM-5PM (Sunday - Wednesday), and provide occasional support on the weekends or other shifts
• Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting)
• Requires up to 5% domestic travel to other sites/locations

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$91,000-$147,200

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.

QC Manager – Fairfield, NJ

Summary :

The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed

Responsibilities :

• Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives
• Train and develop analysts
• Formulate, document, and maintain quality control standards and on-going quality control objectives
• Schedule workload to meet release objectives and deadlines
• Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines
• Author analytical methods and SOPs
• Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments
• Develop specifications and analytical methods as required
• Develop analytical methods to support product development projects
• Prepare analytical method validation protocols and reports
• Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed.
• Manage the outsourcing process of testing to contract laboratories
• Ensure lab safety and manage chemical inventory
• Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations
• Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements
• Audit the work of QC Analysts
• Other duties assigned by Management

Education :

• Bachelor’s degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years’ experience in laboratory management OR Master’s degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years’ experience in laboratory management

Experience Requirements:

• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with GC sample preparation and testing
• Knowledge of USP Monograph testing, analytical method development & validation
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes, lab safety and GDP.

Computer Skills:

• Proficiency in Microsoft Word
• Proficiency in Microsoft excel
• Proficiency in Empower 3

Other requirements:

• Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory.
• Able to perform complex mathematical problems
• In depth knowledge of all laboratory equipment, practices, and procedures
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English
• Able to lift 25 pounds
• Able to stand for extended periods

Hours :

• Standard: 8:30 AM to 5:00 PM, Monday through Friday
• Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

QA/QC Director – Fairfield, NJ

Summary:

The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.

Responsibilities

• To ensure that the production facility is operating at a high operational and compliance standard.
• Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
• Monitor each department’s operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company’s clients.
• Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
• Ensure that deadlines are met
• Train and develop colleagues
• Assist employees to solve problems, using quality management techniques
• Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
• Help to promote the implementation of quality systems throughout the company
• Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
• Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
• Other duties assigned by Management

Education:

• Bachelor’s degree in a scientific discipline with a minimum of 10 years’ experience in quality management

Experience Requirements:

• Experienced with liquid manufacturing and packaging of Rx products.
• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with ANDA and NDA submissions
• Experience with validations of processes, cleaning, analytical methods, facilities and equipment
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes and GDP.

Computer Skills:

• Microsoft Word
• Microsoft Excel
• Empower 3

Other Requirements:

• Has significant technical knowledge of quality management principles.
• In depth knowledge of all laboratory equipment, practices, and procedures
• Ability to think logically and independently
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English

Remote Work: No
Overview:
At Zebra, we are a community of innovators who come together to create new ways of working to make everyday life better. United by curiosity and care, we develop dynamic solutions that anticipate our customer's and partner's needs and solve their challenges.
Being a part of Zebra Nation means being seen, heard, valued, and respected. Drawing from our unique perspectives, we collaborate to deliver on our purpose. Here you are a part of a team pushing boundaries to redefine the work of tomorrow for organizations, their employees, and those they serve.
You have opportunities to learn and lead at a forward-thinking company, defining your path to a fulfilling career while channeling your skills toward causes that you care about - locally and globally. We've only begun reimaging the future - for our people, our customers, and the world.
Responsible for the daily QC Lab functions, including testing of product, calibration of lab equipment, testing for raw materials and paperwork and process audits.
2nd Shift: 2PM - 10:30PM
Responsibilities:
+ To perform this job successfully, a qualified individual must be able to perform each essential duty satisfactorily either with or without reasonable accommodation. The requirements listed in this job description document are representative of the knowledge, skill, and/or ability required.
+ Follows priorities utilizing the Daily Priorities form.
+ Responsible for timely achievement of assigned tasks and efficient time management, typically works under close supervision.
+ Learns to perform and report daily testing of product according to established methods and requirements related to raw materials test/inspection/approval/release, final release processes. Supports the in-process testing.
+ Actively participates in the Quality Control Daily Targets related to safety, quality, delivery and cost.
+ Under detailed instruction evaluates test data to support production and engineering.
+ Monitor and report test status of various production runs to QC Manager, Manufacturing Manager, QC Supervisor, Technology, or Process Engineer.
+ Identifies out-of-specification materials, including placing product on hold, proper identification, and segregation of nonconforming materials, initiating non-conforming material report (NCR) and participating in investigations.
+ Provides support to Engineering, IT and R&D including participation in product/process development trials, carrying out new types of raw material and product characterization/performance testing and use of experimental materials.
+ Maintains and performs necessary calibration of densitometers.
+ Supports data collection activities by entering information into various databases and spreadsheets.
+ Supports calibration program activities to ensure overall Quality Management Process (QMP) compliance.
+ Verifies completeness of quality related documentation.
+ Maintains and adheres to all company safety policies and procedures.
+ Maintains work area organization and documentation to satisfy ISO and GMP standards.
+ Maintains good communication and working relationships with all departments and effectively functions within a team environment.
+ Exhibits professional etiquette that exemplifies the values of the organization.
Qualifications:
Required Qualifications:
+ High School diploma or equivalent
+ Relevant work experience
Preferred Requirements:
+ Experience in an ISO or GMP environment
+ Excellent organizational skills
+ Ability to work independently with little supervision
+ Good communication skills, written and oral
+ Ability to read and interpret data, including graphs, as they relate to test results
+ Ability to collect pertinent data, establishes facts, draw conclusions, and identify problems
+ Word processing, spreadsheet (Corel & Excel), and e-mail software in a Windows environment
Come join the herd!
Zebra is an equal opportunity/affirmative action employer committed to a diverse and inclusive workplace All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability and protected veteran status or any other basis prohibited by law. If you are an individual with a disability and need assistance in applying for a position, please contact us at .
Know Your Rights:
zc a sus Derechos:
will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Zebra is a federal contractor and is committed to an alcohol and drug free workplace. As a result, all U.S. based employees are subject to the Drug and Alcohol Free Workplace Policy and Procedure.
Work for a company that cares, offers a growth environment, and a culture of respect, inclusion and recognition - our front-line workers have an average 7-year tenure!
+ Healthcare, Dental & Vision, Tuition Reimbursement
+ 401k with Company Match
+ Quarterly Cash Incentive Opportunity
+ 20 Days Starting PTO
+ 2 Floating Holidays and Paid Volunteer Time Off
+ Annual Shoe Allowance and free Company Apparel
To all recruitment agencies: Zebra does not accept agency resumes. Please do not forward resumes to Zebra employees or any other team members. Zebra is not responsible for any fees related to unsolicited resumes and direct engagement with Zebra employees.
Zebra Total Rewards includes more than just pay and is structured to meet the needs of our changing global business and evolving talent. We are committed to providing our employees with a benefits program that is comprehensive and competitive - including healthcare, wellness, inclusion networks, and continued learning and development offerings. We offer community service days, in addition to the traditional insurances, compensation, parental leave, employee assistance program and paid time off offerings depending on the country where you work.
Salary: USD 20.00 Hourly
Salary offered will vary depending on your location, job-related skills, knowledge, and experience.
Additionally, all Zebra roles are eligible for cash incentive programs. For example, sales roles have additional opportunity to earn substantial variable compensation tied to quota achievement. In most other roles, the Zebra annual cash incentive program links Company and individual performance together. Some roles may also be eligible for long-term incentive equity awards.
To protect candidates from falling victim to online fraudulent activity involving fake job postings and employment offers, please be aware our recruiters will always connect with you via @zebra.com ( email accounts. Applications are only accepted through our applicant tracking system and only accept personal identifying information through that system. Our Talent Acquisition team will not ask for you to provide personal identifying information via e-mail or outside of the system. If you are a victim of identity theft contact your local police department.

QC Manager Fairfield, NJ

Summary :

The QC Manager is primarily responsible for the daily operation of pharmaceutical Quality Control Laboratory. This position will manage the staff to schedule and perform all necessary testing to support manufacturing and release requirements. Responsible for training and personnel development. This is a hands- on position. In addition to managerial responsibilities, this position will be performing analytical testing including wet chemistry, GC, HPLC, etc. as needed

Responsibilities :

• Lead, coach and manage a team of analysts to ensure data integrity and performance to meet business objectives
• Train and develop analysts
• Formulate, document, and maintain quality control standards and on-going quality control objectives
• Schedule workload to meet release objectives and deadlines
• Review, interpret, analyze and report HPLC/GC/UV/FTIR data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines
• Author analytical methods and SOPs
• Clean, maintain, and troubleshoot HPLC/GC/UV/FTIR instruments
• Develop specifications and analytical methods as required
• Develop analytical methods to support product development projects
• Prepare analytical method validation protocols and reports
• Perform Laboratory Investigations, root cause analysis, CAPA, Change Controls, Validations, Stability Programs, APRs, statistical analysis, environmental monitoring of air, water, and surfaces, as needed.
• Manage the outsourcing process of testing to contract laboratories
• Ensure lab safety and manage chemical inventory
• Improve the compliance of the laboratory operations as well improve the efficiency and reduce the cost of the operations
• Perform duties of QC Analyst as needed including HPLC sample preparation and testing and any other testing requirements
• Audit the work of QC Analysts
• Other duties assigned by Management

Education :

• Bachelors degree in a scientific discipline (Chemistry preferred) with a minimum of 5 years experience in laboratory management OR Masters degree in a scientific discipline (Chemistry preferred) with a minimum of 3 years experience in laboratory management

Experience Requirements:

• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with GC sample preparation and testing
• Knowledge of USP Monograph testing, analytical method development & validation
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes, lab safety and GDP.

Computer Skills:

• Proficiency in Microsoft Word
• Proficiency in Microsoft excel
• Proficiency in Empower 3

Other requirements:

• Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory.
• Able to perform complex mathematical problems
• In depth knowledge of all laboratory equipment, practices, and procedures
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English
• Able to lift 25 pounds
• Able to stand for extended periods

Hours :

• Standard: 8:30 AM to 5:00 PM, Monday through Friday
• Occasionally: Extended hours and/or Saturday and Sunday may be required as necessary to support manufacturing.

QA/QC Director Fairfield, NJ

Summary:

The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.

Responsibilities

• To ensure that the production facility is operating at a high operational and compliance standard.
• Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
• Monitor each departments operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the companys clients.
• Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
• Ensure that deadlines are met
• Train and develop colleagues
• Assist employees to solve problems, using quality management techniques
• Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
• Help to promote the implementation of quality systems throughout the company
• Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
• Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
• Other duties assigned by Management

Education:

• Bachelors degree in a scientific discipline with a minimum of 10 years experience in quality management

Experience Requirements:

• Experienced with liquid manufacturing and packaging of Rx products.
• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with ANDA and NDA submissions
• Experience with validations of processes, cleaning, analytical methods, facilities and equipment
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes and GDP.

Computer Skills:

• Microsoft Word
• Microsoft Excel
• Empower 3

Other Requirements:

• Has significant technical knowledge of quality management principles.
• In depth knowledge of all laboratory equipment, practices, and procedures
• Ability to think logically and independently
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English