QC Compliance & Data Review Specialist III QMS/LIMS

QC Compliance & Data Review Specialist III

Job Type: Contract – 6 Months

Location: Frederick, MD

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

Job Overview

We are seeking an experienced QC Compliance & Data Review Specialist III to support Quality Control operations in a regulated pharmaceutical or biotechnology environment. This role focuses on quality record management, independent review of GMP laboratory data, data integrity, and inspection readiness.

The ideal candidate will have strong knowledge of cGMP requirements, Good Documentation Practices, laboratory data review, and quality management systems.

Key Responsibilities

• Manage and track quality records, including deviations, laboratory investigations, CAPAs, change controls, and effectiveness checks.
• Perform independent reviews of GMP laboratory data, test worksheets, calculations, instrument outputs, electronic records, and supporting documentation.
• Ensure data integrity and compliance with ALCOA principles and applicable regulatory requirements.
• Identify documentation gaps, discrepancies, atypical results, and potential data integrity concerns; ensure appropriate documentation and escalation.
• Review Certificates of Analysis (COAs), product release data packages, stability data, and OOS/OOT investigations, as applicable.
• Maintain compliance trackers, dashboards, metrics, and trend reports to monitor quality records and QC performance.
• Support internal audits, regulatory inspections, and inspection-readiness activities.
• Author, review, and revise SOPs, work instructions, forms, technical reports, and other controlled documents.
• Collaborate with QC Operations, Quality Assurance, Manufacturing, and cross-functional teams to resolve compliance issues and meet deadlines.
• Support continuous improvement initiatives, root cause analysis, risk assessments, and CAPA effectiveness activities.
• Provide guidance and training on documentation practices, data integrity, and quality record requirements.

Required Qualifications

• Master’s degree in a relevant scientific or technical discipline with 3 years of relevant experience; OR
• Bachelor’s degree in a relevant scientific or technical discipline with 5 years of relevant experience; OR
• High school diploma or equivalent with 9 years of relevant experience.
• Experience in pharmaceutical, biotechnology, biologics, cell therapy, or another regulated GMP environment.
• Hands-on experience reviewing GMP laboratory data and supporting quality records, including deviations, investigations, CAPAs, and change controls.
• Strong knowledge of cGMP, Good Documentation Practices, data integrity principles, and 21 CFR Parts 11, 210, and 211.
• Experience with electronic Quality Management Systems (QMS), document management systems, and Laboratory Information Management Systems (LIMS).
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong analytical, organizational, documentation, and communication skills.
• Ability to manage multiple priorities independently and work effectively with cross-functional teams.

Preferred Qualifications

• Experience in commercial cell therapy or biologics Quality Control.
• Experience reviewing analytical or microbiological laboratory data supporting product release, stability, environmental monitoring, or in-process testing.
• Familiarity with Veeva, TrackWise, GVault, LabVantage, or similar quality systems.
• Experience with OOS/OOT investigations, root cause analysis, risk assessments, and CAPA management.
• Experience preparing compliance metrics, dashboards, and inspection-ready documentation.

Contract Details

• Duration: 6 months
• Location: Frederick, MD
• Work Schedule: Monday–Friday, 8:30 AM–5:00 PM

Qualified candidates with strong GMP compliance, laboratory data review, and quality record management experience are encouraged to apply.