Senior Specialist, QA OTF

2 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
Job Summary

Catalent Inc is seeking a highly skilled Quality Assurance Specialist to provide support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The ideal candidate will have a strong background in Quality Assurance, Good Manufacturing Practices (GMPs), and biologics/biopharmaceuticals.

Key Responsibilities
  • Provide QA On-The-Floor (OTF) oversight of manufacturing operations, including observing critical processes and reviewing documentation for compliance.
  • Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
  • Perform Acceptable Quality Limit (AQL) visual inspection of drug product, review and approve batch documents, and generate or revise GMP documentation as needed.
  • Identify and implement continuous improvement initiatives, participate in site and corporate quality and process improvement initiatives, and make solid quality decisions with limited oversight.
  • Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
Requirements
  • Masters' degree in a Scientific, Engineering, or Biotech field with 2+ years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
  • Familiarity with GMPs, 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
  • Knowledgeable and/or exposure to biological manufacturing processes, including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
  • Ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.
Why Catalent?
  • Defined career path and annual performance review and feedback process.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • Dynamic, fast-paced work environment.
  • Generous 401K match and Paid Time Off accrual.
  • Medical, dental, and vision benefits effective day one of employment.
  • Tuition Reimbursement.
  • Wellhub program to promote overall physical wellness.
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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