10 Manufacturing Companies jobs in Mount Arlington

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.

Job Type
Full-time

Description

About Us: Westrafo America is the first US based facility specializing in the design and manufacturing of high-quality transformers. We are committed to excellence and are looking to expand our team with dedicated professionals who share our passion for electrical engineering and manufacturing.

Position Overview: We are seeking a detail-oriented Quality Control Inspector to join our team. The ideal candidate will be responsible for ensuring that our transformers meet the highest quality standards and comply with industry regulations. This role is critical to maintaining our reputation for quality and reliability as we scale our operations.

Key Responsibilities:

• Conduct inspections of raw materials, in-process components, and finished products to ensure compliance with specifications and standards.
• Develop and implement quality control procedures and guidelines.
• Perform testing and analysis on transformers to identify defects or areas for improvement.
• Document inspection results and maintain accurate records of quality metrics.
• Collaborate with production teams to address quality issues and implement corrective actions.
• Conduct root cause analysis for quality defects and develop strategies for prevention.
• Ensure compliance with safety and regulatory standards in all quality control processes.
• Participate in continuous improvement initiatives to enhance product quality and operational efficiency.

• High school diploma or equivalent; associate or bachelor's degree in engineering or a related field preferred.
• Previous experience in quality control or manufacturing, preferably in the electrical or transformer industry.
• Knowledge of quality control standards and methodologies (e.g., ISO 9001).
• Strong attention to detail and analytical skills.
• Proficient in using measurement tools and equipment (calipers, micrometers, etc.).
• Excellent communication and teamwork skills.
• Ability to work independently and manage multiple tasks effectively.

• Competitive salary and performance-based bonuses.
• Health, dental, and vision insurance.
• Retirement savings plan.
• Opportunities for professional development and career advancement.
• A dynamic and innovative work environment.

Job Type
Full-time

Description

About Us: Westrafo America is the first US based facility specializing in the design and manufacturing of high-quality transformers. We are committed to excellence and are looking to expand our team with dedicated professionals who share our passion for electrical engineering and manufacturing.

Position Overview: We are seeking a detail-oriented Quality Control Inspector to join our team. The ideal candidate will be responsible for ensuring that our transformers meet the highest quality standards and comply with industry regulations. This role is critical to maintaining our reputation for quality and reliability as we scale our operations.

Key Responsibilities:

• Conduct inspections of raw materials, in-process components, and finished products to ensure compliance with specifications and standards.
• Develop and implement quality control procedures and guidelines.
• Perform testing and analysis on transformers to identify defects or areas for improvement.
• Document inspection results and maintain accurate records of quality metrics.
• Collaborate with production teams to address quality issues and implement corrective actions.
• Conduct root cause analysis for quality defects and develop strategies for prevention.
• Ensure compliance with safety and regulatory standards in all quality control processes.
• Participate in continuous improvement initiatives to enhance product quality and operational efficiency.

• High school diploma or equivalent; associate or bachelor's degree in engineering or a related field preferred.
• Previous experience in quality control or manufacturing, preferably in the electrical or transformer industry.
• Knowledge of quality control standards and methodologies (e.g., ISO 9001).
• Strong attention to detail and analytical skills.
• Proficient in using measurement tools and equipment (calipers, micrometers, etc.).
• Excellent communication and teamwork skills.
• Ability to work independently and manage multiple tasks effectively.

• Competitive salary and performance-based bonuses.
• Health, dental, and vision insurance.
• Retirement savings plan.
• Opportunities for professional development and career advancement.
• A dynamic and innovative work environment.

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

About Us

Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Purpose

The Associate Director, QC, acts as senior leadership for the Quality Control operation at Evergreen Theragnostics. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. They will ensures processes are designed and compliant per applicable cGMPs, Evergreen Theragnostics’ procedures, and that processes are defined consistently with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices.

Key Responsibilities/Essential Functions

• Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization.
• Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill.
• Define specific qualification standards for SMEs and the subsequent qualification processes.
• Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department.
• Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables.
• Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements.
• Oversee and manage departmental efficiency and proficiency to enable a lean operation.
• Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders.
• Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
• Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics’ business growth.
• Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from ‘sending’ sites for an optimized analytical process.
• Leads, motivate, mentor, and develops team members to exceed and meet company goals.
• Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities.
• Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
• Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment.
• Report and take initiative to correct safety and environmental hazards.
• Actively demonstrate Evergreen Theragnostics’ values.

Typical Minimum Skills and Experience and Education

• Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required.
• 2+ years of experience in the radiopharmaceutical industry preferred but not required
• Minimum 10+ years experience in a GMP Quality Control Environment.
• Minimum 5+ years experience in people management and conflict resolution.
• Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections.
• Previous experience with managing a microbiology department is preferred.
• Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred.

Other Requirements

• Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes.
• Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment.
• Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes.
• Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing.
• Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
• Ability to work in a fast paced, complex and changing environment.
• Excellent analytical, technical and experiences.
• Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills.
• Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired.
• Experience working with external partners is highly desirable.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Keen insight, independent judgment and tactful discretion are required.
• Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture”.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics’ to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism.
• Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.

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

About Us

Evergreen Theragnostics is a Lantheus owned company, headquartered in Bedford, Massachusetts with offices in Springfield, New Jersey. Evergreen Theragnostics is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Evergreen our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someones health is in our hands.We believe in helping people be their best and seek to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Purpose

The Associate Director, QC, acts as senior leadership for the Quality Control operation at Evergreen Theragnostics. This position will oversee and lead the QC department at Evergreen. This role will be accountable for governing the department in terms of function and responsibility as well as providing technical guidance/decisions (when needed) for the operational levels to ensure an efficient and structured operation that can cater to internal as well as external needs within the organization to deliver quality radiopharmaceutical products. This role will be the primary accountable person for the success of the QC department operations at Evergreen Theragnostics in terms of efficiency, skill retention and compliance. They will ensures processes are designed and compliant per applicable cGMPs, Evergreen Theragnostics procedures, and that processes are defined consistently with regulatory filings. This role must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices.

Key Responsibilities/Essential Functions

• Design, establish and maintain a standard QC operational structure with assigned roles and responsibilities that can be aligned with the needs of the organization.
• Oversee the creation and maintenance of a QC training matrix and program to ensure consistency in execution and retention of capability & skill.
• Define specific qualification standards for SMEs and the subsequent qualification processes.
• Manage mid-management (supervisors, managers etc) direction to ensure alignment of objectives and completion of deliverables by the department.
• Provide technical guidance and decisions to mid-management in order to be able to achieve the required objectives and deliverables.
• Design, maintain and defend the internal departmental processes to ensure compliance to cGXP requirements.
• Oversee and manage departmental efficiency and proficiency to enable a lean operation.
• Review and approve department related protocols, procedures, test methods, and studies as appropriate. Responsible to create, maintain and harmonize key business processes with internal and external stakeholders.
• Partner with the Internal and CDMO management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
• Partner with Business Development (BD) team in identifying and evaluating new technological platforms and pipeline products for Evergreen Theragnostics business growth.
• Partner with site operations to effectively deliver analytical services to meet product release timelines for future product supply. Partner with existing sites in the network to incorporate lessons learned from sending sites for an optimized analytical process.
• Leads, motivate, mentor, and develops team members to exceed and meet company goals.
• Develop and maintain effective working relationships with other division groups and external partners in support of technology transfer, validation, and process support activities.
• Lead assigned operational personnel in owning Quality processes within the required responsibility of the department (i.e. Change controls, Investigations, CAPAs, Protocol & report writing)
• Responsible to review and co-author key CMC sections with external partners and cross functional stakeholders.
• Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment.
• Report and take initiative to correct safety and environmental hazards.
• Actively demonstrate Evergreen Theragnostics values.

Typical Minimum Skills and Experience and Education

• Requirements include a B.S. in relevant scientific/technical disciplines, advanced degrees (e.g., MS) or technological certificates preferred but not required.
• 2+ years of experience in the radiopharmaceutical industry preferred but not required
• Minimum 10+ years experience in a GMP Quality Control Environment.
• Minimum 5+ years experience in people management and conflict resolution.
• Minimum 3+ years experience in defending QC operations against FDA and EMEA regulatory inspections.
• Previous experience with managing a microbiology department is preferred.
• Previous experience working with sterile filled/finished drug products, medical device, radiopharmaceuticals and CDMO management strongly preferred.

Other Requirements

• Subject matter expert (SME) in various analytical test methods and analytical technology. Strong knowledge of global regulatory requirements related to the design and control of these processes.
• Knowledge of SOPs, cGMPs, GCPs and GLPs and the ability to work and manage within a regulatory environment.
• Demonstrated experience with the execution of technology transfer and scale up programs for commercial drug product analytical processes.
• Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing & testing.
• Excellent organizational skills and the ability to successfully manage a multitude of technical projects.
• Ability to work in a fast paced, complex and changing environment.
• Excellent analytical, technical and experiences.
• Proactive mindset with strong leadership, facilitation, teamwork, and influence management/negotiation skills.
• Understanding of FDA and/or EMEA quality and regulatory processes. Prior experience with regulatory filings is highly desired.
• Experience working with external partners is highly desirable.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Keen insight, independent judgment and tactful discretion are required.
• Ability to function autonomously, with an appreciation of detail while being cognizant of the big picture.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required. Candidate represents Evergreen Theragnostics to external organizations and must exhibit the highest levels of personal integrity, quality, and professionalism.
• Travel may be required and is dictated by product needs and project deliverables, including overnight travel to Evergreen Theragnostics and CDMO locations.