Senior QC Compliance Lead - GMP/Biologics

Catalent Pharma Solutions; Glen Burnie (MD); Vor Ort; USD 100.000 - 120.000; Vollzeit

Benefits dieser Stelle

Career growth opportunities

Diversity & inclusion culture

Paid time off + 8 holidays

Medical, dental, and vision benefits

Zusammenfassung

Catalent Pharma Solutions in Harmans, MD is seeking a Senior QC Compliance Specialist to lead investigations, deviations, and CAPAs, ensuring GMP compliance and continuous improvement of quality systems in the analytical lab.

You will produce management reports, support QC metrics, and participate in internal audits, site-wide quality initiatives, and audit readiness. This role is 100% onsite at Harmans, MD.

Qualifikationen

• Bachelor’s degree in biology or life sciences with 3–5 years in quality/compliance.
• Experience with analytical and/or bioanalytical testing processes.
• Knowledge of regulatory principles with ability to enhance quality systems; Lean familiarity is desirable.
• Experience with GMPs and regulatory guidelines (ICH, USP, EU GMPs).
• Proficiency with electronic systems (LIMS/EDMS/ERP) is desirable.

Aufgaben

• Support timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.
• Track and trend QC analytical metrics and provide management reports identifying risks.
• Collaborate on QC CAPA effectiveness evaluations using quantitative/qualitative measures.
• Maintain tracking mechanisms to support QC analytical metrics.
• Monitor QC systems for compliance and improvements; provide compliance support to QC.
• Participate in QC compliance remediation plans and implementations.
• Assist with GMP documentation generation and revision (SOPs).
• Establish and execute a laboratory audit readiness program for ongoing 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 qualifications and startups.

Kenntnisse

QC Compliance

CAPA investigations

Deviation handling

Documentation control

GMP knowledge

Ausbildung

Bachelor’s degree in biology

Tools

LIMS

EDMS

ERP systems

Jobbeschreibung

Catalent Pharma Solutions in Harmans, MD is seeking a Senior QC Compliance Specialist to lead investigations, deviations, and CAPAs, ensuring GMP compliance and continuous improvement of quality systems in the analytical lab.

You will produce management reports, support QC metrics, and participate in internal audits, site-wide quality initiatives, and audit readiness. This role is 100% onsite at Harmans, MD.