Senior QC Compliance Analyst (GMP Bio Lab)

Catalent; Harmans (MD); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical benefits from day one

Dental benefits

Vision benefits

Paid time off + 8 holidays

Job summary

Catalent in Harmans, MD is seeking a Senior QC Compliance Specialist to support regulatory adherence and continuous quality improvement in the Analytical Laboratory. The role focuses on managing investigations, deviations, CAPAs, and QC metrics to drive quality across GMP manufacturing of biological products.

You will collaborate with Quality Systems, generate protocols, and support facility qualifications, with an emphasis on timely documentation and compliance readiness in a fast-paced

Qualifications

• Bachelor's degree in biology or life sciences with 3–5 years in quality or compliance.
• Experience with analytical and/or bioanalytical testing processes.
• Knowledge of regulatory principles; exposure to Lean Operational Excellence is desirable.
• Experience with GMPs and QA documentation systems (LIMS/EDMS/ERP).
• Experience with CAPAs, deviations, and investigations in pharma/biologics.

Responsibilities

• Support timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.
• Track and trend QC systems; provide management reports on risks and trends.
• Collaborate to evaluate CAPA effectiveness using quantitative and qualitative measures.
• Maintain tracking for QC analytical metrics and ensure compliance.
• Assist with GMP documentation such as SOPs and audit readiness programs.
• Participate in internal QC audits and project teams for quality improvement.

Skills

Quality Assurance

CAPA management

Investigations

GMP knowledge

LIMS/EDMS/ERP

Education

Bachelor's degree in biology or life sciences

Tools

LIMS

EDMS

ERP systems

Job description

Catalent in Harmans, MD is seeking a Senior QC Compliance Specialist to support regulatory adherence and continuous quality improvement in the Analytical Laboratory. The role focuses on managing investigations, deviations, CAPAs, and QC metrics to drive quality across GMP manufacturing of biological products.

You will collaborate with Quality Systems, generate protocols, and support facility qualifications, with an emphasis on timely documentation and compliance readiness in a fast-paced