QC Compliance & Data Review Specialist III

Our client, a Biopharmaceutical company, is looking for a QC Compliance & Data Review Specialist III for their Frederick, MD location.
 
Responsibilities:

• Compliance Records Management
• Manage and own QC quality records in the Quality Management System, including deviations, laboratory investigations, CAPAs, change controls, impact assessments, and effectiveness checks, as assigned.
• Monitor record progress, due dates, approvals, and supporting documentation; identify risks to timely closure and escalate issues through the appropriate governance pathway.
• Review records for clear problem statements, accurate chronology, scientifically sound conclusions, appropriate root cause evaluation, and complete supporting evidence.
• Maintain organized, inspection-ready records in accordance with approved procedures, document lifecycle controls, and applicable retention requirements.
• Coordinate with record owners, reviewers, and approvers to resolve documentation gaps and drive timely completion.
• Data Review and Data Integrity
• Perform independent technical review of GMP laboratory data, electronic records, test worksheets, instrument output, calculations, audit trails, and supporting documentation, as qualified and assigned.
• Confirm data are complete, consistent, attributable, legible, contemporaneous, original or a verified true copy, accurate, enduring, and available in accordance with ALCOA+ principles.
• Reconcile data across source records and laboratory systems to verify sample identity, method execution, calculations, specifications, result transcription, and traceability.
• Identify discrepancies, atypical observations, missing information, potential data integrity concerns, and procedural noncompliance; ensure issues are documented and escalated appropriately.
• Support review of Certificates of Analysis, product release data packages, stability data, invalid assay records, and OOS/OOT or laboratory investigation documentation, as applicable.
• Compliance Oversight and Reporting
• Develop and maintain compliance trackers, dashboards, metrics, and trend reports for quality records, data review, invalid assays, OOS/OOT events, and other QC performance indicators.
• Analyze recurring documentation or data-review issues and recommend risk-based actions to improve right-first-time performance and laboratory compliance.
• Support periodic record reviews, inspection-readiness assessments, internal audits, regulatory inspections, and responses to document or data requests.
• Prepare clear summaries and evidence packages that enable management review and inspection readiness.
• Partner with Quality Assurance and QC leadership to communicate emerging compliance risks and recommended mitigation actions.
• Procedures, Training and Continuous Improvement
• Author, revise, and review SOPs, work instructions, forms, protocols, technical reports, and job aids supporting QC compliance and data-review activities.
• Serve as a subject matter expert for assigned compliance records, documentation practices, data review, and related electronic systems.
• Train and mentor QC personnel on record quality, review expectations, data integrity, and Good Documentation Practices.
• Lead or support cross-functional improvement initiatives that simplify workflows, strengthen controls, improve cycle time, and reduce repeat documentation errors.
• Provide compliance and data-review support during system implementation, business process changes, and planned or unplanned system outages.
• Perform other duties as required.
• Works independently on complex assignments and determines appropriate approaches within established policies and procedures.
• Acts as a technical and compliance resource for peers and cross-functional partners.
• Leads assigned quality records, data-review activities, and improvement initiatives from planning through completion.
• Uses data and risk-based judgment to identify issues, recommend actions, and escalate significant compliance concerns.
• Provides coaching and knowledge transfer to developing reviewers and record owners.
• Communicate with QC Operations and cross-functional partners to coordinate data review, records completion, testing support, and resolution of quality-related issues.
• Monitor compliance with documented policies, applicable quality objectives, regulatory requirements, company procedures, and departmental practices.
• Review and interpret information contained in electronic and paper records, laboratory systems, reports, and controlled documents.
• Prepare and maintain accurate electronic records, written reports, metrics, presentations, and technical documentation.
• Use standard office and laboratory information systems for extended periods and participate in virtual or in-person meetings.
• Work effectively in a regulated environment where accuracy, attention to detail, confidentiality, and timely escalation are essential.

• Master's degree in a relevant scientific or technical discipline and 3+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; or
• Bachelor's degree in a relevant scientific or technical discipline and 5+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; or
• High school diploma or equivalent and 9+ years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment.
• Experience reviewing GMP laboratory data and managing or supporting quality records such as deviations, laboratory investigations, CAPAs, and change controls.
• Knowledge & Other Requirements
• Strong working knowledge of cGMP, Good Documentation Practices, data integrity principles, and applicable regulatory requirements, including 21 CFR Parts 11, 210, and 211.
• Demonstrated ability to review complex laboratory and compliance records, recognize deviations from approved practices, and document clear, evidence-based conclusions.
• Working knowledge of root cause analysis, laboratory investigations, risk assessment, CAPA, change control, and inspection-readiness practices.
• Experience with electronic Quality Management Systems, document management systems, and Laboratory Information Management Systems. Experience with GVault, Veeva, TrackWise, or LabVantage is preferred.
• Proficiency with Microsoft Word, Excel, PowerPoint, and data reporting or visualization tools.
• Excellent written and verbal communication, organizational, analytical, and problem-solving skills.
• Ability to manage multiple priorities with minimal direction, meet committed timelines, and adapt to changing operational needs.
• Ability to influence without direct authority and collaborate effectively across Quality, Manufacturing, Technical Operations, and other functions.
• Ability to maintain confidentiality and exercise sound judgment when handling sensitive quality and compliance information.
• Willingness to work a schedule that supports business needs and to provide occasional off-shift or weekend support, as required.
• Experience in commercial cell therapy or biologics Quality Control operations.
• Experience reviewing analytical or microbiological test data supporting in-process, final product, environmental monitoring, stability, or product release activities.
• Experience preparing data packages and supporting internal audits or regulatory inspections.
• Experience developing metrics, dashboards, or trend reports using Excel, Power BI, or comparable tools.
• Formal training or practical experience in data integrity, investigation writing, root cause analysis, or operational excellence methodologies

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities