QC Compliance & Data Review Specialist III

TekWissen•Frederick, MD

19h•Onsite

About The Position

This individual-contributor role manages QC compliance records and independently reviews laboratory and quality data to ensure accuracy, completeness, traceability, and compliance with current Good Manufacturing Practices, approved procedures, and data-integrity expectations. The position supports commercial cell therapy operations, product disposition, inspection readiness, and continuous improvement in partnership with QC Operations, QC Technical Services, Quality Assurance, Manufacturing, and other cross-functional teams. The specialist owns and monitors assigned quality records in the Quality Management System, reviews records and GMP laboratory data, identifies and escalates discrepancies or compliance risks, and maintains inspection-ready documentation. The role also develops compliance metrics and reports, supports audits and inspections, authors and reviews controlled procedures and training materials, and coaches QC personnel on documentation and data-review practices. The role works independently on complex assignments, leads assigned activities through completion, and serves as a technical and compliance resource for peers and cross-functional partners.

Requirements

Master's degree in a relevant scientific or technical discipline and at least 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 at least 5 years of relevant experience; or high school diploma or equivalent and at least 9 years of relevant experience.
Experience reviewing GMP laboratory data and managing or supporting quality records such as deviations, laboratory investigations, CAPAs, and change controls.
Strong working knowledge of cGMP, Good Documentation Practices, data-integrity principles, and applicable regulatory requirements, including 21 CFR Parts 11, 210, and 211.
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.
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 provide occasional off-shift or weekend support, as required.
Ability to work independently on complex assignments and determine approaches within established policies and procedures.
Ability to lead assigned quality records, data-review activities, and improvement initiatives from planning through completion; use data and risk-based judgment to identify issues, recommend actions, and escalate significant compliance concerns.
Ability to provide coaching and knowledge transfer to developing reviewers and record owners.
Ability to communicate and coordinate effectively with QC Operations and cross-functional partners, review and interpret electronic and paper information, prepare accurate records and reports, use standard office and laboratory information systems for extended periods, and participate in virtual or in-person meetings.
Ability to work effectively in a regulated environment where accuracy, attention to detail, confidentiality, and timely escalation are essential.

Nice To Haves

Experience with GVault, Veeva, TrackWise, or LabVantage.
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.

Responsibilities

Manage assigned QC quality records in the Quality Management System, including deviations, laboratory investigations, CAPAs, change controls, impact assessments, and effectiveness checks.
Monitor record progress, due dates, approvals, and supporting documentation; identify risks to timely closure and escalate issues through appropriate governance pathways.
Review quality 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 retention requirements.
Coordinate with record owners, reviewers, and approvers to resolve documentation gaps and drive timely completion.
Independently review assigned GMP laboratory data, electronic records, test worksheets, instrument output, calculations, audit trails, and supporting documentation.
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.
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 summaries and evidence packages for management review and inspection readiness; communicate emerging compliance risks and mitigation recommendations with Quality Assurance and QC leadership.
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 to 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.
Coordinate with QC Operations and cross-functional partners on data review, records completion, testing support, and resolution of quality-related issues.
Monitor compliance with documented policies, quality objectives, regulatory requirements, company procedures, and departmental practices.
Review and interpret information in electronic and paper records, laboratory systems, reports, and controlled documents.
Prepare and maintain accurate electronic records, written reports, metrics, presentations, and technical documentation.
Perform other duties as required.