QC Compliance & Data Review Specialist III

VARITE • Frederick, MD

1d • Onsite

About The Position

VARITE is seeking a QC Compliance & Data Review Specialist III to join the Quality Control organization in Frederick, Maryland. This onsite contract role supports commercial cell therapy operations and is responsible for managing QC compliance records and independently reviewing laboratory and quality data for accuracy, completeness, traceability, and compliance with current Good Manufacturing Practices, approved procedures, and data integrity expectations. The assignment is described as a six-month contract with possible extension and is anticipated to last approximately four to six months.

The specialist works with QC Operations, QC Technical Services, Quality Assurance, Manufacturing, and other cross-functional partners to support timely product disposition, inspection readiness, and continuous improvement. The role manages quality records, reviews GMP laboratory data and associated documentation, identifies and escalates discrepancies and compliance risks, and develops reporting and inspection-support materials. It also contributes to procedures, training, system and process changes, and improvement initiatives. The position is an independent contributor role that handles complex assignments, serves as a technical and compliance resource, leads assigned work through completion, and coaches developing reviewers and record owners.

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 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 appropriate 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 communicate and coordinate effectively, review and interpret electronic and paper records, and prepare accurate documentation in a regulated environment requiring accuracy, attention to detail, confidentiality, and timely escalation.
• Ability to use standard office and laboratory information systems for extended periods and participate in virtual or in-person meetings.

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 documents; identify closure risks 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 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.
• Verify data completeness, consistency, attribution, legibility, contemporaneousness, originality or verified true-copy status, accuracy, endurance, and availability 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; 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 and 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 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.
• 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 improvements 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, record 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.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Company-sponsored retirement savings plan
• Legal service plans providing access to attorneys for advice and representation
• Potential eligibility for an employee referral bonus if a referred candidate is hired

What This Job Offers

• Career Level: Senior
• Education Level: High school or GED