QC Compliance & Data Review Specialist III

Iconma Portal•Frederick, MD

2d•Onsite

About The Position

The QC Compliance & Data Review Specialist III manages and reviews Quality Control compliance records and GMP laboratory data in a regulated biopharmaceutical environment. The role owns assigned quality records in the Quality Management System, including deviations, laboratory investigations, CAPAs, change controls, impact assessments, and effectiveness checks. It monitors record status, due dates, approvals, and supporting documentation; identifies closure risks; and coordinates with record owners and reviewers to resolve gaps and complete records on time. The specialist independently reviews laboratory data and associated records, including electronic records, test worksheets, instrument output, calculations, audit trails, and supporting documentation, as qualified and assigned. The role checks data against ALCOA+ principles and reconciles source records with laboratory systems for identity, execution, calculations, specifications, transcription, and traceability. It supports review of Certificates of Analysis, product release and stability data, invalid assays, and OOS/OOT or laboratory investigation documentation, as applicable. The position develops compliance trackers, dashboards, metrics, and trend reports; supports periodic reviews, audits, inspections, and information requests; and prepares summaries and evidence packages. It authors and reviews procedures and related controlled documents, serves as a subject matter expert, trains and mentors QC personnel, and leads or supports improvement initiatives and system or process changes. The specialist works independently on complex assignments, provides technical guidance to peers, uses risk-based judgment, and coordinates with QC Operations and cross-functional partners. The work requires accuracy, attention to detail, confidentiality, timely escalation, and use of electronic and paper records, laboratory systems, office tools, and virtual or in-person meetings.

Requirements

Master's degree in a relevant scientific or technical discipline and 3 or more years of relevant experience in a biologics, cell therapy, pharmaceutical, or other regulated GMP environment; or a bachelor's degree in a relevant scientific or technical discipline and 5 or more years of relevant experience; or a high school diploma or equivalent and 9 or more 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 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 within established policies and procedures, use data and risk-based judgment, and escalate significant compliance concerns.
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 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.
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 meet ALCOA+ principles and reconcile source records with laboratory systems for sample identity, method execution, calculations, specifications, result transcription, and traceability.
Identify discrepancies, atypical observations, missing information, potential data integrity concerns, and procedural noncompliance; document and escalate issues 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 to QA and QC leadership.
Author, revise, and review SOPs, work instructions, forms, protocols, technical reports, and job aids supporting QC compliance and data review.
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.
Lead assigned quality records, data-review activities, and improvement initiatives from planning through completion; provide 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, 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.
Use standard office and laboratory information systems for extended periods and participate in virtual or in-person meetings.
Perform other duties as required.