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QC Compliance & Data Review Specialist III

VARITE is looking for qualified QC Compliance & Data Review Specialist III in Frederick, MD (Onsite)

WHAT THE CLIENT DOES?

An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title:

QC Compliance & Data Review Specialist III Location:

Frederick, MD 21704 (Onsite)

Contract Duration:

6-month contract with possible extension.

Pay Rate Range:

$35.00 - $38.73/hr. on

W2 HERE'S WHAT YOU'LL DO

Function:

Quality Control, Compliance and Data Review Position Overview:

• Everyone at
• is grounded by one common goal: curing cancer. Every day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission.
• We are seeking a highly motivated QC Compliance & Data Review Specialist III (Contract) to join the Quality Control organization in Frederick, Maryland.
• This is a temporary contract assignment anticipated to last approximately four to six months.
• The individual contributor role is responsible for managing QC compliance records and performing independent review of laboratory and quality data to ensure accuracy, completeness, traceability, and adnce to current Good Manufacturing Practices, approved procedures, and data integrity expectations.
• The role partners with QC Operations, QC Technical Services, Quality Assurance, Manufacturing, and other cross-functional stakeholders to support commercial cell therapy operations, timely product disposition, inspection readiness, and continuous improvement.

Key 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