QC Compliance & Data Review Specialist III

Aptask Global Workforce (AGW) is seeking a Quality Control Research Associate for an Onsite position with a Leading Biotechnology Company located in Frederick, MD. This is a 4+ to 6+ month contract opportunity.

We are seeking a highly motivated individual to join the Quality Control organization. This 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, Quality Assurance, Manufacturing, and other cross-functional stakeholders to support commercial cell therapy operations, timely product disposition, and inspection readiness.

Responsibilities:

• Manage and own QC quality records in the Quality Management System, including deviations, laboratory investigations, CAPAs, and change controls
• Monitor record progress, due dates, approvals, and supporting documentation; identify risks and escalate issues
• Perform independent technical review of GMP laboratory data, electronic records, test worksheets, and supporting documentation
• Confirm data are complete, consistent, and accurate in accordance with ALCOA+ principles
• Identify discrepancies, atypical observations, missing information, and potential data integrity concerns
• Develop and maintain compliance trackers, dashboards, metrics, and trend reports
• Support periodic record reviews, internal audits, and regulatory inspections
• Author, revise, and review SOPs, work instructions, and technical reports
• Train and mentor QC personnel on record quality, review expectations, and Good Documentation Practices

Requirements:

• Master's degree in a relevant scientific discipline and 3+ years of experience in a biologics, cell therapy, or pharmaceutical GMP environment; OR
• Bachelor's degree in a relevant scientific discipline and 5+ years of relevant experience; OR
• High school diploma and 9+ years of relevant experience
• Experience reviewing GMP laboratory data and managing quality records such as deviations, laboratory investigations, CAPAs, and change controls
• Strong working knowledge of cGMP, Good Documentation Practices, and data integrity principles (21 CFR Parts 11, 210, and 211)
• Experience with electronic Quality Management Systems (eQMS), document management systems, and Laboratory Information Management Systems (LIMS)
• Proficiency with Microsoft Word, Excel, and PowerPoint
• Excellent written and verbal communication, organizational, and analytical skills

Desired skills:

• Experience in commercial cell therapy or biologics Quality Control operations
• Experience reviewing analytical or microbiological test data
• Experience preparing data packages and supporting internal audits or regulatory inspections
• Experience developing metrics or dashboards using Excel, Power BI, or comparable tools
• Formal training in data integrity, investigation writing, or root cause analysis
• Experience with GVault, Veeva, TrackWise, or LabVantage is preferred

Pay range: up to $39.56 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.