RCI-GILD-17390 QC/ QA Deviation Writing Specialist - Frederick, MD

QC Compliance & Data Review Specialist III (Contract)

Only requirement is that we have someone that has strong GMP experience writing deviations and managing CAPA's and CCR's plus someone that can be quickly trained to support data review, if needed on some QC method. Someone with QC testing experience is a plus, but I would be open to someone with a QA background as long as they have deviation writing experience with and comfortable using electronic QMS system.

Frederick, MD

Schedule: M-F from 8:30am – 5pm

FUNCTION

• Quality Control, Compliance and Data Review

POSITION OVERVIEW

• 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.

LEVEL EXPECTATIONS

• Works independently on complex assignments and determines appropriate approaches within established policies and procedures.
• Acts as a technical and compliance resource for peers and cross-functional partners.
• Leads assigned quality records, data-review activities, and improvement initiatives from planning through completion.
• Uses data and risk-based judgment to identify issues, recommend actions, and escalate significant compliance concerns.
• Provides coaching and knowledge transfer to developing reviewers and record owners.

ESSENTIAL JOB FUNCTIONS

• 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, applicable quality objectives, regulatory requirements, company procedures, and departmental practices.
• Review and interpret information contained 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.
• Work effectively in a regulated environment where accuracy, attention to detail, confidentiality, and timely escalation are essential.

PREFERRED QUALIFICATIONS

• 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.

CONTRACT POSITION NOTICE

This position is a temporary contract assignment with an anticipated duration of four to six months. The actual assignment length may be adjusted based on business needs. This contract assignment does not guarantee extension or conversion to a regular employee position.