Quality Assurance Manager

4 weeks ago

Exton, Pennsylvania, United States Joulé Full time
Job Title:
Quality Control Manager

As a Quality Control Manager at Joulé, you will be responsible for leading a team of Quality Control analysts and Environmental Monitoring specialists to ensure the highest standards of quality in our biologics production process. This role requires a strong background in quality control, regulatory compliance, and technical writing.

Responsibilities:
• Manage a team of Quality Control analysts and Environmental Monitoring specialists to ensure day-to-day scheduling of activities is appropriately resourced.
• Maintain the Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status.
• Manage laboratory equipment upkeep, calibration, and preventive maintenance, ensuring proper documentation in logbooks and electronic management systems.
• Ensure all method qualification and validation is current, including bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays.
• Keep apprised of compendial changes and ensure compliance with compendia for all test procedures.
• Manage external vendors providing lab services and materials, maintaining appropriate inventory through effective order management and adherence to departmental budget.
• Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug Product.
• Participate in the establishment of phase-appropriate specifications and ensure data integrity is maintained for all applications, programs, and executed work.
• Generate protocols, technical reports, and other documentation as needed, and author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, root cause analyses, and risk assessment as needed.
• Raise critical quality issues to upper management and perform internal audits to ensure compliance with cGMP's.
• Write and revise Quality Systems SOPs and other documentation as necessary to maintain compliance, and support audit of external parties and regulatory inspections.
• Ensure full compliance with applicable health and safety regulations, such as OSHA, and demonstrate a willingness to engage with a high-energy team in pursuit of organizational goals and strategies.

Requirements:
• Minimum Bachelor of Science degree in a relevant scientific discipline.
• Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance.
• Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards.
• Technical writing experience in a similar role in the biologics or pharmaceutical industry.
• Experience in aseptic processing and/or mammalian cell culture production.
• Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills.
• Ability to prioritize and successfully execute multiple tasks simultaneously, and work with a high degree of accuracy and detail.
• Positive work attitude that supports teamwork and continuous improvement.

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title:Quality Assurance ManagerAt Joulé, we are seeking a highly skilled Quality Assurance Manager to join our team. This role will be responsible for ensuring that our quality systems meet the highest standards of excellence.Responsibilities:Collaborate with cross-functional teams to ensure that quality systems are aligned with business...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States System One Full time

    Job Title: Quality Assurance ManagerLocation: Exton, PAType: Contract to hireSchedule: Monday - Friday Day HoursResponsibilities: Oversee a team of Quality Control analysts and Environmental Monitoring specialists to ensure effective day-to-day scheduling of activities Maintain the Environmental Monitoring Program, including monthly trend analysis, yearly...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Quality Control ManagerJob Summary: We are seeking a highly experienced Quality Control Manager to join our team at Joulé. The successful candidate will be responsible for managing a staff of Quality Control analysts and Environmental Monitoring specialists, ensuring that day-to-day scheduling of activities is appropriately resourced.Key...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States System One Holdings, LLC Full time

    Job Title: Quality Control ManagerLocation: Exton, PAType: Contract to hireSchedule: Monday - Friday Day HoursResponsibilities:Lead a team of Quality Control analysts and Environmental Monitoring specialists to ensure day-to-day scheduling of activities is appropriately resourced.Maintain the Environmental Monitoring Program, including monthly trend...

  • Quality Assurance Manager

    3 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Quality Control ManagerLocation: Exton, PASalary Range: 110-140kSchedule: Monday - Friday Day HoursOur client is a rapidly growing cell & gene therapy company seeking a dynamic Quality Control Manager to join the team in Exton, PA. This is a unique opportunity to build and develop a talented team while driving positive culture...

  • Quality Assurance Manager

    3 weeks ago

    Exton, Pennsylvania, United States System One Full time

    Job Title: Quality Control ManagerLocation: Exton, PASalary Range: kSchedule: Monday - Friday Day HoursSystem One is seeking a Quality Control Manager to join our team in Exton, PA. As a key member of our Quality team, you will play a vital role in shaping the future of our QC department.This is a dynamic management role that offers the opportunity to build...

  • Director of Quality Assurance

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Director of Quality AssuranceFrontage Laboratories is seeking a highly skilled and experienced Director of Quality Assurance to join our team.Job Summary:The Director of Quality Assurance will play a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and...

  • Director of Quality Assurance

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job SummaryThe Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance.This position is responsible for monitoring manufacturing, packaging, releasing, disposition, testing, and validation activities,...

  • Director of Quality Assurance

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Summary:The Director of Quality Assurance, Pharmaceutical Manufacturing plays a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and compliance. This position ensures seamless integration with global quality processes.Responsibilities:Manage the quality assurance...

  • Quality Assurance Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Integrated Resources Full time

    {"Job Title": "Quality Assurance Specialist", "Job Description": "Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Integrated Resources. The successful candidate will be responsible for ensuring the quality and suitability of raw materials for production processes.Key ResponsibilitiesConduct detailed analysis of raw...

  • Quality Assurance Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Innovative Solutions and Support Full time

    Job DescriptionAt Innovative Solutions and Support, we are seeking a Quality Inspector to join our team in Exton, PA. As a Quality Inspector, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform inspection of all incoming material; perform in-process and final inspections, as required.Work with...

  • Quality Assurance Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Idemia Full time

    Job SummaryWe are seeking a highly detail-oriented Quality Assurance Specialist to join our team at Idemia. The successful candidate will be responsible for ensuring the quality of our manufacturing processes and products.ResponsibilitiesCount work in the manufacturing process and reconcile count balances between processes.Maintain a chain of custody on all...

  • Quality Assurance Specialist

    3 weeks ago

    Exton, Pennsylvania, United States Beacon Hill Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Specialist to join our team at Beacon Hill. As a Quality Assurance Specialist, you will be responsible for performing testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein, and cell-based assays.Key...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Zenith LifeScience Full time

    Job Title: Senior Quality Assurance SpecialistWe are seeking a highly skilled Raw Materials Expert to join our team at Zenith LifeScience. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality and suitability of raw materials for our production processes.This role involves working closely with cross-functional teams to...

  • Quality Assurance Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Beacon Hill Full time

    Job SummaryWe are seeking a highly skilled Quality Control Scientist to join our team at Beacon Hill. The successful candidate will be responsible for performing testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays.Key ResponsibilitiesExecute analytical test...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Exton, Pennsylvania, United States Zenith LifeScience Full time

    We are seeking a highly skilled Raw Material Expert with extensive knowledge and hands-on experience in Raman spectroscopy to join our team at Zenith LifeScience.The successful candidate will be responsible for the analysis and characterization of raw materials, ensuring their quality and suitability for production processes.This role involves working...

  • Quality Assurance Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Idemia Full time

    ResponsibilitiesAs a Quality Auditor, you will be responsible for ensuring the quality of our manufacturing process. This includes:Counting work in the manufacturing process and reconciling count balances between processes.Maintaining a chain of custody on all material removed from jobs during the manufacturing process.Entering count information accurately...

  • Quality Control Manager

    3 weeks ago

    Exton, Pennsylvania, United States System One Full time

    Job Title: Quality Control ManagerSchedule: Monday - Friday Day HoursOur client is a cell & gene therapy company that is rapidly growing. They are looking for a dynamic Quality Control Manager to play a key role in shaping the future of the QC department.This is more than just a management role—it's an opportunity to build and develop a talented team while...

  • Senior Quality Control Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Associate Director Quality ControlAs a key member of our Quality Control team, you will be responsible for managing a staff of Quality Control analysts and Environmental Monitoring specialists. Your primary focus will be on ensuring that day-to-day scheduling of activities is appropriately resourced and that the Environmental Monitoring Program is...

  • Senior Quality Control Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Summary: We are seeking a highly experienced Senior Quality Control Manager to lead our Quality Control team. The ideal candidate will have a strong background in Quality Control, with a minimum of 10 years of experience in the biologics industry. The successful candidate will be responsible for managing a staff of Quality Control analysts and...