Job Description
Job Description
About Atrium:
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Client Overview: Our client is a pharmaceutical contract development and manufacturing organization (CDMO) that helps other companies develop and manufacture drugs on a contract basis, focused on oral solid dosage products & ingestible powder products. They are seeking a
QC Data Reviewer to ensure data accuracy, integrity, and compliance within the Quality Control (QC) laboratory.
Salary/Hourly Rate: $38/hr - $43/hr (Temp)
$80k - $90k (Perm)
Position Overview: The QC Data Reviewer will be responsible for conducting detailed, accurate, and timely reviews of analytical and microbiological data produced within the QC laboratory. This role plays a critical part in maintaining compliance with current Good Manufacturing Practices (cGMP), internal SOPs, and applicable regulatory standards. The QC Data Reviewer acts as a key quality gatekeeper-verifying that all data, documentation, and results are complete, consistent, and compliant before approval or release. This position requires strong attention to detail, technical expertise in laboratory systems, and a commitment to upholding the highest standards of data integrity.
Responsibilities of the QC Data Reviewer: - Review analytical and microbiological data, chromatograms, and calculations for accuracy and compliance with SOPs, cGMP, and regulatory guidelines.
- Verify that test results meet specifications and follow ALCOA+ data integrity principles.
- Ensure completeness and accuracy of raw data, worksheets, and results before final approval.
- Review instrument outputs and system suitability results (e.g., HPLC, GC, FTIR, UV, KF).
- Identify and report discrepancies, deviations, or data integrity concerns to management.
- Support timely batch release by completing reviews within required timelines.
- Collaborate with lab staff and QA to clarify data and resolve documentation issues.
- Participate in investigations and CAPAs related to lab data or testing.
- Assist with continuous improvement of data review processes and compliance practices.
Required Experience/Skills for the QC Data Reviewer: - Minimum 10 - 15 years of experience in a cGMP-regulated pharmaceutical environment.
- Strong understanding of Good Documentation Practices (GDP) and data integrity principles.
- Familiarity with laboratory instrumentation and methods (HPLC, GC, KF, UV, FTIR, Dissolution, etc.).
Preferred Experience/Skills for the QC Data Reviewer: - Strong preference for candidates with prior QC and QA data review experience.
Education Requirements: - Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
Benefits: - Benefits include Medical, Dental, and Vision coverage.
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As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO
Position ID: 158302
Job Tags
Hourly pay, Permanent employment, Contract work, Temporary work,