Senior Quality Assurance Engineer

4 weeks ago


Philadelphia, Pennsylvania, United States Catalent Inc Full time

About the Role:

Catalent Inc is seeking a Senior Quality Assurance Engineer to join our team in Philadelphia. As a Senior Quality Assurance Engineer, you will be responsible for providing Quality Assurance guidance and support for activities related to Manufacturing and Packaging operations at Catalent Philadelphia.

Key Responsibilities:

  • Supports regulatory compliance with FDA cGMPs, DEA requirements, Clinical Supply Services (CSS) Network Standard Operating Procedures, and Catalent CSS Philadelphia local Standard Operating Procedures.
  • Responsible for performing/reviewing product quality complaint investigations, process deviations, and validation protocols.
  • Oversees special projects, compliance issues, and provides possible corrective actions to remedy the issues and prevent future occurrences.

Requirements:

  • Bachelor's Degree with at least two years of relevant experience; OR an Associate's Degree with at least four years of relevant experience; OR a High School Diploma / GED with at least eight years of relevant experience OR ten years of relevant experience.
  • Required discipline of degree of Science or Engineering.
  • Proven track record of monitoring/auditing quality and identifying potential efficiencies in a production environment is preferred.
  • Experience in a regulated, pharmaceutical field is strongly preferred.
  • Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is preferred.

Why Catalent:

Catalent is a global, high-growth, private company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. We offer a diverse, inclusive culture, a positive working environment focusing on continually improving processes to remain innovative, and potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

What We Offer:

  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • Positive working environment focusing on continually improving processes to remain innovative.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • 152 Hours + 8 paid holidays.
  • Several Employee Resource Groups focusing on D&I.
  • Dynamic, fast-paced work environment.
  • Community engagement and green initiatives.
  • Generous 401K match.
  • Company match on donations to organizations.
  • Medical, dental and vision benefits effective day one of employment.
  • Tuition Reimbursement – Let us help you finish your degree or start a new degree.
  • 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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