Senior QC Compliance & Data Review Specialist

Hiring: Senior QC Compliance & Data Review Specialist (Contract)

Location: Frederick, Maryland

Schedule: Monday–Friday, 8:30 AM–5:00 PM

Contract Duration: 4–6 months

Industry: Biopharmaceuticals / Cell Therapy

About the Role

We are seeking an experienced Senior QC Compliance & Data Review Specialist to support Quality Control operations in a regulated biopharmaceutical environment.

The ideal candidate will have hands-on experience reviewing GMP laboratory data, managing quality records, and ensuring compliance with cGMP regulations, Good Documentation Practices (GDP), and data integrity requirements.

This role is ideal for a quality professional who can independently review complex laboratory records, identify compliance issues, support investigations, and maintain inspection-ready documentation.

Key Responsibilities

• Review GMP laboratory data, raw data, test results, calculations, instrument outputs, and supporting documentation for accuracy, completeness, and traceability.
• Manage and review quality records, including deviations, laboratory investigations, CAPAs, change controls, and impact assessments.
• Ensure compliance with ALCOA+ data integrity principles and Good Documentation Practices.
• Identify data discrepancies, documentation gaps, procedural deviations, and potential compliance risks, and ensure appropriate escalation.
• Support the review of Certificates of Analysis (CoAs), product release data packages, stability data, and OOS/OOT investigations, as applicable.
• Monitor quality records, track due dates, and coordinate with cross-functional teams to support timely closure.
• Prepare and maintain compliance trackers, metrics, trend reports, and quality documentation.
• Support internal audits, regulatory inspections, and inspection-readiness activities.
• Review and update SOPs, work instructions, and other controlled documents as required.
• Collaborate with QC, Quality Assurance, Manufacturing, and Technical Operations teams to improve quality processes and data integrity.

Required Qualifications

• Relevant education and GMP experience meeting one of the following:
• Master's degree in a relevant scientific or technical discipline with 3+ years of relevant experience.
• Bachelor's degree in a relevant scientific or technical discipline with 5+ years of relevant experience.
• High school diploma or equivalent with 9+ years of relevant experience.
• Hands-on experience in a pharmaceutical, biotechnology, biologics, or other regulated GMP environment.
• Experience reviewing GMP laboratory data and managing or supporting deviations, CAPAs, laboratory investigations, and change control s.
• Strong understanding of cGMP, Good Documentation Practices, and ALCOA+ data integrity principles.
• Working knowledge of 21 CFR Parts 11, 210, and 211.
• Experience with electronic Quality Management Systems (eQMS), document management systems, or Laboratory Information Management Systems ( LIMS ).
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to work independently, manage multiple priorities, and meet deadlines.

Preferred Qualifications

• Experience in commercial cell therapy or biologics Quality Control operations.
• Familiarity with Veeva Vault, GVault, TrackWise, LabVantage, or similar quality and laboratory systems.
• Experience with audit trail review, product release documentation, OOS/OOT investigations, and inspection readiness.
• Experience using Excel or Power BI for compliance tracking, reporting, and trend analysis.
• Experience with root cause analysis, risk assessments, and CAPA effectiveness checks.

Interested?

If you have strong GMP compliance, laboratory data review, and quality systems experience, we encourage you to apply or reach out to learn more about this opportunity.

#Hiring #QualityControl #GMP #Biopharmaceuticals #QualityCompliance #DataIntegrity #CAPA #BiotechJobs #ContractJobs