Quality Assurance Specialist Senior

5 days ago

Philadelphia, Pennsylvania, United States Adaptimmune Full time

Job Title: Quality Assurance Specialist Senior

Job Summary:

Adaptimmune is seeking a Quality Assurance Specialist Senior to provide quality oversight on product, process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Adaptimmune's validation practices and procedures.

Key Responsibilities:

  • Responsible for QA review and approval of all validation records and documentation.
  • Assist in the monitoring of quarterly reports, periodic reviews and/or revalidation of equipment and processes.
  • Review and approve protocol discrepancies related to manufacturing process equipment, utilities, computer systems, validation, and laboratory instruments.
  • Ensure GMP compliance in all areas of validation/qualification and that systems are fully validated/qualified and all documentation completed before they are released for GMP use.
  • Liaise with key personnel within project teams to ensure validation tasks are completed in a timely manner.
  • Review the content of technical lifecycle documentation ensuring compliance with the validated state of the process.
  • Collaborate on the Aseptic Process Validation strategies, assessments and protocols to ensure the Navy Yard manufacturing facility remains compliant.
  • Assist with the Data Integrity Audit Trail Review implementation at the Navy Yard Site.
  • Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation.
  • Support process improvement & change management initiatives by assessing impact to the validated state of the process and equipment.
  • Maintain inspection readiness and actively support regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors.
  • Stay current with industry trends and standards (PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
  • Participate in routine plant operating meetings (CAPA, Deviation, Change Control) and serve as Quality Engineering SME.

Qualifications & Experience:

  • Bachelor's Degree in Science or related technical field.
  • Minimum of 5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.
  • Must demonstrate understanding of cGMP's, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations.
  • Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
  • Strong knowledge of global regulatory requirements for Clinical and Commercial GMP computerized systems validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
  • Knowledge of Quality Risk Management principles and experience with performing risk assessments using a variety of tools, i.e. FMEA.
  • Must be able to work well on cross-functional teams, as well as perform independently. Strong organizational skills are required and must be able to prioritize multiple tasks.
  • Must possess strong verbal/written communication skills and ability to influence at all levels.
  • Experience utilizing quality systems to support Quality Engineering activities (Document management, Training, Deviation management, Change Control management, and CAPA).
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.

Desirable:

  • Experience with Calibration manager databases, Electronic Lab Notebooks, Veeva, Validation Data Acquisition systems (ie Kaye, Ellab, TempTale), Building Management systems, Document Control Software
  • Experience with leading the start-up, validation, and licensure of manufacturing facilities.
  • Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic processes (aseptic process validation).
  • Experience working with cell and gene therapies or biologics products.
  • Experience working with external parties and/or leading cross-functional teams.

At Adaptimmune:

We embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category.

  • Senior Quality Assurance Specialist

    5 days ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary:We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of our products throughout the development and manufacturing processes.Key Responsibilities:Quality...

  • Senior Quality Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job Title: Senior Quality Assurance SpecialistWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Iovance Biotherapeutics Inc. This role will be responsible for ensuring the quality and regulatory compliance of our commercial and clinical products.Key Responsibilities:Represent Iovance QA by working on-site at contract...

  • Senior Quality Assurance Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States Marshwinds International Incorporated Full time

    Job Title: Senior Quality Assurance SpecialistJob Summary: We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Marshwinds International Incorporated. The ideal candidate will have a strong background in both manual and automated testing, with a focus on ensuring the quality and reliability of our software products.Key...

  • Quality Assurance Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Quality Assurance Engineering SpecialistMeet our growing Biotech client, seeking a Quality Assurance Engineering Specialist/Senior level to join their team in Philadelphia, PA.Job Summary:As a Quality Assurance Engineering Specialist in the pharmaceutical industry, you will play a critical role in ensuring the quality and compliance of our products...

  • Senior Quality Assurance Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job Title: Senior Quality Assurance SpecialistWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Iovance Biotherapeutics Inc. This role will be responsible for ensuring the quality and regulatory compliance of commercial and clinical products, including manufacturing, testing, and release at contract service providers.Key...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Quality Assurance Engineering SpecialistMeet our growing Biotech client, a leading pharmaceutical company seeking a Quality Assurance Engineering Specialist to join their team.Job Summary:As a Quality Assurance Engineering Specialist, you will play a critical role in ensuring the quality and compliance of our products throughout the development and...

  • Senior Quality Assurance Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

    Job Title: Senior Quality Assurance SpecialistWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Iovance Biotherapeutics Inc. This role will play a critical part in ensuring the quality and regulatory compliance of our commercial and clinical products.Key Responsibilities:Represent Iovance QA by working on-site at the...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Job Summary:As a Quality Assurance Engineering Specialist, you will play a critical role in ensuring the quality and compliance of our products throughout the development and manufacturing processes.You will collaborate with cross-functional teams to implement quality assurance strategies, conduct risk assessments, and ensure adherence to industry...

  • Quality Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States PATIENT CARE COORDINATION, INC. Full time

    Quality Assurance SpecialistJoin Patient Care Coordination, Inc. as a Quality Assurance Specialist and play a vital role in ensuring the highest quality of care for our patients.About the Role:We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring that our...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Adaptimmune Full time

    Job Title: Sr. Quality Assurance SpecialistAdaptimmune is a leading biotechnology company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our company culture is...

  • Senior Quality Assurance Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States Adaptimmune Full time

    Job Title: Sr. Quality Assurance SpecialistAdaptimmune is a leading biotechnology company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.Our company culture is...

  • Quality Assurance Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States Meet Full time

    Job Title: Quality Assurance SpecialistJob Summary:Meet is seeking a Quality Assurance Specialist to ensure the quality and compliance of our products throughout the development and manufacturing processes. As a Quality Assurance Specialist, you will collaborate with cross-functional teams to implement quality assurance strategies, conduct risk assessments,...

  • Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Patient Care Coordination Inc Full time

    Job Title: Quality Assurance SpecialistAt Patient Care Coordination Inc, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the highest level of quality in our services, ensuring compliance with regulatory standards, and identifying areas for improvement.Key...

  • Senior Quality Assurance Engineer

    1 week ago

    Philadelphia, Pennsylvania, United States Insight Global Full time

    Job Title: Senior Quality Assurance EngineerWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Insight Global. As a Senior Quality Assurance Engineer, you will be responsible for ensuring the quality of our software applications by designing and executing comprehensive testing strategies.Key Responsibilities:Design and...

  • Senior Quality Assurance Specialist for Lot Disposition

    1 week ago

    Philadelphia, Pennsylvania, United States Adaptimmune Full time

    Job DescriptionAt Adaptimmune, we are committed to delivering high-quality cell therapy products to patients with cancer. As a Senior Quality Assurance Specialist for Lot Disposition, you will play a critical role in ensuring the quality and safety of our products.Key Responsibilities:Conduct record reviews of batch records, QC testing data, and associated...

  • Quality Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Pennsylvania Medicine Full time

    Schedgistration Quality Assurance SpecialistPenn Medicine is committed to delivering exceptional patient care, advancing medical research, and educating future healthcare leaders. As a Schedgistration Quality Assurance Specialist, you will play a vital role in ensuring the highest quality registration workflows and processes.Key Responsibilities:Develop and...

  • Senior Quality Assurance Engineer

    3 weeks ago

    Philadelphia, Pennsylvania, United States Comcast Corporation Full time

    Job Title: Senior Quality Assurance EngineerComcast Corporation is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality assurance team, you will be responsible for providing technical leadership in developing test strategies and designing quality assurance practices.Key Responsibilities:Develop and...

  • Quality Assurance Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States PeopleShare Inc Full time

    PeopleShare is seeking a Quality Assurance Specialist to join their team in the Lehigh Valley. This role offers competitive pay and a hybrid schedule, making it an attractive opportunity for those in the pharmaceutical industry.The ideal candidate will have a Bachelor's Degree in Science, Engineering, or Pharmacy, along with 5-7 years of experience in the...

  • Quality Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job Title: Quality Assurance Specialist IWuXi AppTec is seeking a highly skilled Quality Assurance Specialist I to join our team. As a Quality Assurance Specialist I, you will play a critical role in ensuring the quality of our products and services.Job Summary:The Quality Assurance Specialist I will be responsible for reviewing laboratory testing...

  • Quality Assurance Specialist

    1 week ago

    Philadelphia, Pennsylvania, United States PeopleShare Inc Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at PeopleShare Inc. The ideal candidate will have a strong background in quality control and assurance, with excellent communication and analytical skills.Job Responsibilities:Perform regular audits to ensure compliance with quality standards.Recommend improvements to...