Data Reviewer I
Job Summary
We are seeking a highly detail-oriented Data Reviewer to support Quality Assurance oversight of Quality Control laboratory activities. This role involves performing comprehensive reviews of scientific data and laboratory documentation to ensure accuracy, integrity, compliance, and audit readiness within a cGMP-regulated pharmaceutical environment.
What You'll Do
Scientific Data Review & Compliance - Perform thorough, in-depth reviews of Quality Control laboratory documentation and scientific data for completeness, accuracy, integrity, and compliance. Review laboratory records including: In-process testing data, API and excipient testing records, finished product testing records, stability study data, cleaning verification results, instrument calibration records, contract laboratory reports, regulatory submission support documentation (including ANDA-related materials).
Data Integrity Oversight - Verify that all laboratory activities and records comply with applicable cGMP requirements and site procedures. Review audit trails and electronic data generated through computerized GxP laboratory systems. Ensure laboratory documentation adheres to ALCOA++ Data Integrity principles. Identify discrepancies, inconsistencies, or compliance concerns and escalate findings as appropriate.
Quality Systems & Regulatory Support - Maintain Quality Assurance oversight of Quality Control functions to ensure continuous inspection and audit readiness. Ensure documentation complies with: cGMP requirements, internal SOPs, USP, BP, EP compendial requirements, ICH guidance, FDA and other applicable regulatory expectations. Support departmental goals, quality initiatives, and continuous improvement activities. Assist with audit preparation and support regulatory inspections as needed.
Cross-Functional Collaboration - Partner with Quality Control, Quality Assurance, and laboratory personnel to resolve documentation and compliance issues. Provide guidance and feedback regarding laboratory documentation practices and data integrity expectations. Perform additional assignments and special projects as directed by Quality Management.
Work Environment
- Frequent sitting and computer-based work.
- Regular use of hands and arms to perform data review and documentation activities.
- Occasional standing, walking, bending, stooping, kneeling, or crouching when visiting laboratory areas.
- Close vision, distance vision, color vision, and the ability to adjust focus.
- Ability to lift and/or move up to 10 pounds.
Physical Requirements
- Frequent sitting and computer-based work.
- Regular use of hands and arms to perform data review and documentation activities.
- Occasional standing, walking, bending, stooping, kneeling, or crouching when visiting laboratory areas.
- Close vision, distance vision, color vision, and the ability to adjust focus.
- Ability to lift and/or move up to 10 pounds.
Education & Experience
- Bachelor's degree required.
- Minimum 3 years of experience in a pharmaceutical environment.
- Minimum 2 years of hands-on chromatography experience, including HPLC (Empower preferred), GC, FTIR, UV/Visible Spectroscopy, Malvern Particle Size Analyzers, and wet chemistry techniques.
- Experience reviewing laboratory records and supporting compliance activities in a regulated environment preferred.
Why Join Us?
- Play a vital role in ensuring the integrity and compliance of pharmaceutical laboratory data.
- Work closely with Quality Assurance and Quality Control teams in a highly regulated environment.
- Develop expertise in data integrity, regulatory compliance, and laboratory quality systems.
- Gain exposure to audit readiness initiatives and regulatory inspections.
- Join a collaborative organization committed to quality, compliance, and continuous improvement.