Senior QC Compliance Specialist
About The Position
The Senior QC Compliance Specialist supports compliance in the Quality Control Analytical Laboratory at Catalent’s Harmans/BWI campus. The role authors, manages, and tracks investigations, events, deviations, and other quality records, and supports compiling, trending, and reporting quality metrics for management accountability. The specialist helps ensure regulatory compliance and continuous improvement of quality systems for GMP manufacturing of biological products. The position is based 100% onsite in Harmans, Maryland, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. The campus includes FDA-licensed, CGMP manufacturing facilities supporting Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines.
Requirements
- Bachelor’s degree in biology or another life sciences discipline.
- 3–5 years of experience in a quality or compliance function.
- Experience with analytical and/or bioanalytical testing processes.
- Knowledge of scientific and regulatory principles and the ability to enhance quality systems.
- Experience with Good Manufacturing Practices (GMPs).
- Experience developing, reviewing, and approving CAPAs, deviations, and investigations in the pharmaceutical or biologics industry, especially in analytical or bioanalytical laboratories.
- Experience with International Council for Harmonisation (ICH) Guidelines, United States Pharmacopeia (USP), and European Union (EU) GMPs.
- Ability to learn and navigate electronic systems quickly and work independently or collaboratively in fast-paced environments, applying strong troubleshooting and problem-solving skills.
Nice To Haves
- Exposure to Lean Operational Excellence methodologies is highly desirable.
- Experience working with Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), and Enterprise Resource Planning (ERP) systems is desirable.
- Experience with ddPCR, qPCR, ELISA, pH, osmolality, appearance, CE-SDS, SDS-PAGE, and HPLC.
Responsibilities
- Support timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.
- Track and trend aspects of Quality Control Systems and provide management reports identifying risks and trends.
- Collaborate with the Quality Systems group to perform QC CAPA effectiveness evaluations using quantitative and qualitative measures.
- Maintain tracking mechanisms to support QC analytical metrics.
- Monitor and review QC systems and procedures for compliance, quality improvements, and efficiency, providing compliance support to the QC department.
- Participate in QC compliance remediation plans and their implementation.
- Assist with generating and revising GMP documentation, including standard operating procedures.
- Establish and execute a laboratory audit-readiness program to ensure continuous compliance.
- Participate in QC internal audits as applicable.
- Contribute to site quality and process-improvement initiatives and represent QC Analytical on project teams.
- Provide protocol-generation and execution support for facility and utility qualifications and startups.
- Perform other duties as assigned.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Potential for career growth and a defined career path.
- Annual performance review and feedback process.
- Diverse, inclusive culture.
- Community engagement and green initiatives.
- Bonus potential.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
