QC Compliance & Data Review Specialist

Job Title: QC Data Review Specialist
Location: Frederick, MD 21704
Position Type: Contract
Pay Rate: $29.57 – $39.57 / hour
Schedule: Full-Time | Monday – Friday, 8:30 AM – 5:00 PM (40 hours/week)

About Our Client

Our client is a world-renowned leader in biopharmaceuticals and commercial cell therapy, dedicated to bringing life-saving therapies to patients across the globe. Located at a state-of-the-art facility in Frederick, Maryland, they offer an innovative, fast-paced environment where quality, compliance, and scientific rigor are at the heart of everything they do. Joining this team gives you direct exposure to cutting-edge cell therapy operations and modern Quality Control practices.

Role Overview

We are seeking a highly motivated QC Data Review Specialist for a contract assignment in Frederick, MD. In this individual contributor role, you will manage QC compliance records and perform independent technical reviews of laboratory and quality data to ensure complete accuracy, traceability, and adherence to current Good Manufacturing Practices (cGMP) and data integrity (ALCOA+) expectations. You will partner with cross-functional teams (QC Operations, Quality Assurance, Manufacturing) to support commercial cell therapy operations, timely product release, and regulatory inspection readiness.

Key Responsibilities

1. Compliance Records Management

• Manage and own QC quality records within the Quality Management System (QMS), including deviations, laboratory investigations, CAPAs, change controls, impact assessments, and effectiveness checks.
• Monitor record timelines, track due dates, and mitigate risks to ensure timely record closure.
• Review quality records for scientifically sound conclusions, clear problem statements, robust root cause analysis, and complete evidence.
• Coordinate with record owners and reviewers to resolve documentation gaps and maintain inspection-ready records.

2. Data Review & Data Integrity

• Perform independent technical review of GMP laboratory data, electronic records, test worksheets, instrument output, calculations, and audit trails adhering to ALCOA+ principles.
• Reconcile data across source records and laboratory systems to verify sample identity, method execution, calculations, and specifications.
• Identify and document discrepancies, atypical observations, potential data integrity concerns, and procedural non-compliance.
• Support the review of Certificates of Analysis (CoA), product release packages, stability data, invalid assay records, and OOS/OOT investigations.

3. Compliance Oversight & Reporting

• Develop and maintain compliance trackers, dashboards, and trend reports for key metrics (OOS/OOT, invalid assays, record closure rates).
• Analyze recurring issues to recommend risk-based actions that improve right-first-time performance.
• Support inspection-readiness assessments, internal audits, and regulatory inspections.
• Partner with QA and QC leadership to communicate emerging compliance risks and proposed mitigations.

4. SOPs, Training & Continuous Improvement

• Author, revise, and review SOPs, work instructions, protocols, and technical reports.
• Serve as a Subject Matter Expert (SME) for compliance records, Good Documentation Practices (GDP), and electronic systems.
• Train and mentor QC personnel on record quality, review expectations, and data integrity.
• Support process improvement initiatives to streamline workflows and reduce repeat documentation errors.

Qualifications & Requirements

Education & Experience

• Master’s Degree in a scientific or technical discipline + 3+ years of experience in a biologics, cell therapy, or pharmaceutical cGMP environment; OR
• Bachelor’s Degree in a scientific or technical discipline + 5+ years of experience in a biologics, cell therapy, or pharmaceutical cGMP environment; OR
• High School Diploma / Equivalent + 9+ years of experience in a regulated cGMP environment.

Technical & General Skills

• Laboratory Data Review: Strong hands-on experience reviewing GMP lab data and managing quality records (Deviations, Investigations, CAPA, Change Control).
• Regulatory & Compliance Knowledge: Expert knowledge of cGMP, Good Documentation Practices (GDP), ALCOA+ Data Integrity, and regulatory guidelines (21 CFR Parts 11, 210, 211).
• Systems: Experience with electronic Quality Management Systems (eQMS), LIMS, and document management systems (e.g., Veeva, TrackWise, LabVantage, GVault).
• Software: Proficient in Microsoft Office (Word, Excel, PowerPoint) and data reporting/visualization tools (e.g., Power BI).
• Soft Skills: Exceptional analytical, written/verbal communication, and collaboration skills with the ability to influence without direct authority.

Preferred Qualifications

• Experience in commercial cell therapy or commercial biologics QC operations.
• Experience reviewing analytical or microbiological test data (in-process, release, stability, environmental monitoring).
• Formal training or practical experience in root cause analysis (RCA), investigation writing, or operational excellence.

Work Environment & Schedule

• Shift: Day Shift (8:30 AM – 5:00 PM, Monday – Friday)
• Hours: 40 hours/week with occasional off-shift or weekend support as business needs dictate.

ATR International is an Equal Opportunity Employer.

ATR International is committed to delivering next-generation recruiting that enables businesses and communities to thrive. By bringing passion for excellence, trust, and inclusion to every interaction, we build deep connections with our clients, contractors, internal staff, and local markets to drive long-term mutual success.

Founded in 1988 as a two-person, Hispanic-owned company, ATR is now a widely renowned technical staffing and consulting leader. Our firm has grown to serve a range of companies—from startups to Fortune 500 organizations—while putting more than 35,000 people to work, totaling over 14 million working hours. And we support a plethora of industries, from IT, engineering, and finance to healthcare, insurance, and retail.

Our passion for inclusion is at the heart of our success. Our woman-led, minority-owned firm welcomes fresh perspectives, and our efforts have earned us WBENC Certification—the most prestigious national recognition for women-owned businesses in the U.S. Today, ATR remains one of the most diverse firms in the staffing industry.

Reach out to learn how we can support your staffing or job search needs, no matter your background.