Senior QC Compliance Lead - GMP Bio Lab (Onsite)

Catalent Pharma Solutions; Maryland; Sur place; USD 100 000 - 120 000; Plein temps

Résumé du poste

Catalent Pharma Solutions in Harmans, MD is seeking a Senior QC Compliance Specialist to join the Quality Control Analytical Laboratory. You will author, manage, and track investigations, deviations, and quality records, and help compile key quality metrics for management accountability.

You will support GMP documentation and establish audit readiness to ensure ongoing compliance. The role requires 3–5 years in quality/compliance and experience with analytical or bioanalytical testing,

Qualifications

• 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 GMPs and regulatory principles (ICH, USP, EU GMPs).
• Experience with electronic systems such as LIMS, EDMS, ERP is desirable.
• Experience developing, reviewing, and approving CAPAs, deviations, and investigations.

Responsabilités

• Support timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.
• Track and trend QC analytical metrics and prepare management reports.
• Collaborate with Quality Systems to evaluate CAPA effectiveness using qualitative and quantitative measures.
• Maintain tracking mechanisms for QC analytical metrics and readiness programs for audits.
• Assist with GMP documentation such as SOPs and participate in internal audits and project teams.
• Provide protocol generation and execution support for facility and utility qualifications and startups.

Connaissances

Analytical testing

Bioanalytical testing

GMP knowledge

Quality systems

Problem solving

Independent work

Formation

Bachelor's degree in biology or life sciences

Outils

LIMS

EDMS

ERP systems

Description du poste

Catalent Pharma Solutions in Harmans, MD is seeking a Senior QC Compliance Specialist to join the Quality Control Analytical Laboratory. You will author, manage, and track investigations, deviations, and quality records, and help compile key quality metrics for management accountability.

You will support GMP documentation and establish audit readiness to ensure ongoing compliance. The role requires 3–5 years in quality/compliance and experience with analytical or bioanalytical testing,