Manager, QC Program Management

Full-time - Manager

Harmans, MD

Chemical Manufacturing

About the position

The Manager, QC Client Services is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation. Manage the OTL for analytical method implementation and support SMPs and Batch records implementation review.

Responsibilities

• Be the face of Catalent Quality Control during Client onboarding
• Manage the day-to-day method establishment
• Attend client meetings to establish testing and stability protocols
• Ensure completion of project team assigned QC related activities
• Coordinate internal testing with Quality Control group
• Coordinate product and raw material testing with external testing laboratories
• Coordinate with the stability group and clients to establish stability studies
• Review and approve client sampling plans
• Review and approve batch records
• Ensure sample testing schedule is accurate
• Develop and maintain QC client activities tracker
• Communicate manufacturing and testing schedules to the Quality Control group
• Effectively communicates with clients on QC related items/results

Requirements

• Masters' degree in a Scientific, Engineering or Biotech field with 6 - 8 years' experience in Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review
• Bachelor's degree in a Scientific, Engineering or Biotech field with 8 - 10 years' experience in Quality Assurance/Quality Control function reviewing Analytical testing data for analytical assays such as ELISA, DDPCR, HPLC, SDS-PAGE, Western blot OR as an Analytical Chemist with documentation review
• Proficient in Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
• At least 4 years of Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict
• Demonstrable leadership experience at Catalent may be considered in place of external experience
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

Nice-to-haves

• Exposure to Lean Operational Excellence highly desirable

Benefits

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment