Quality Control Specialist

1 week ago


Chelsea, Massachusetts, United States Catalent Inc Full time

Job Summary:

Catalent Inc is seeking a Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for executing QC testing and related analytical activities supporting product development, release and stability.

Key Responsibilities:

  • Conduct routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures.
  • Compile data for documentation of test procedures that may include stability program testing and formulation studies.
  • Participate in the preparation of investigations, summaries and reports, and review data obtained for compliance to specifications and report out-of-trend and/or out-of-specification results.
  • Operate analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).
  • Statistically and critically analyze data for trending and reporting into regulatory filings.
  • Participate in Laboratory and/or Quality Investigations.
  • Monitor equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
  • Participate in the construction and/or revision of SOPs.
  • Assist in the writing and updating of analytical test procedures, protocol, log books and checklists.
  • Identify and alert a supervisor of issues on instruments and/or test executions, make initial recommendations for possible solutions and/or corrective actions.

Requirements:

  • Bachelor's Degree required. Preferably in Physical or Chemical Sciences (life sciences) with a minimum of 2+ years of relevant work experience required.
  • 1+ years regulated GMP environment experience required.
  • Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.
  • Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required.
  • Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required.
  • Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred.
  • Experience with analytical method development and validation preferred.

Why Catalent:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Catalent offers a dynamic, fast-paced work environment, a diverse, inclusive culture, and a positive working environment focusing on continually improving processes to remain innovative. We also offer a defined career path and annual performance review and feedback process, as well as opportunities for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to [insert email].



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