Senior QC Compliance Specialist

Catalent•Harmans, MD

4d•Onsite

About The Position

The Senior QC Compliance Specialist supports compliance in the Quality Control Analytical Laboratory at Catalent’s FDA-licensed CGMP gene therapy manufacturing campus in Harmans, Maryland. The role focuses on authoring, managing, and tracking investigations, events, deviations, and other quality records, as well as compiling, trending, and reporting quality metrics for management. The successful candidate helps ensure regulatory compliance and continuous improvement of quality systems supporting GMP manufacturing of biological products. The position is 100% onsite at the Harmans/BWI campus and follows a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule. The campus supports Phase 3 through commercial manufacturing of advanced therapeutic products, including AAV and other viral vector-based therapies and vaccines. The role requires a bachelor’s degree in biology or another life sciences discipline and 3–5 years of experience in a quality or compliance function. It also calls for experience with analytical or bioanalytical testing, GMPs, and quality records in pharmaceutical or biologics environments. Preferred laboratory-method experience includes ddPCR, qPCR, ELISA, pH, osmolality, appearance, CE-SDS, SDS-PAGE, and HPLC. The anticipated salary range in Maryland is $100,000–$120,000, plus bonus. Catalent describes its workplace as a diverse and inclusive culture and offers career growth opportunities, paid time off and holidays, medical, dental, and vision benefits effective on the first day of employment, tuition reimbursement, community engagement, and green initiatives.

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 within 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.
Strong troubleshooting and problem-solving skills.

Nice To Haves

Exposure to Lean Operational Excellence methodologies.
Experience with electronic systems such as Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), and Enterprise Resource Planning (ERP) systems.
Experience with ddPCR, qPCR, ELISA, pH, osmolality, appearance, CE-SDS, SDS-PAGE, and HPLC.

Responsibilities

Support and ensure timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.
Track and trend Quality Control Systems and provide management reports identifying risks and trends.
Collaborate with the Quality Systems group on QC CAPA effectiveness evaluations using quantitative and qualitative measures.
Maintain tracking mechanisms for 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, such as standard operating procedures.
Establish and execute a laboratory audit readiness program to support 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.