Quality Control Research Associate - II

QC Compliance & Data Review Specialist III
Frederick, MD
Schedule: M-F from 8:30am 5pm

FUNCTION
Quality Control, Compliance and Data Review

POSITION OVERVIEW
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 adherence 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 as required.

REQUIREMENTS
We are all different, yet we all use our unique contributions to serve patients. The following qualifications and skills are sought for this role.
U.S. Education & Experience
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.