Job Description
Ttg Talent Solutions
Pharmaceutical Quality Control – Data Reviewer Contract Type: Contract (Mid-level) Schedule: Full-time – 2nd shift: 2:30pm-11:30pm If hired for the 2nd shift, you will initially be trained during the 1st shift (7:30 A.M. – Once your training is complete, you will transition to your regular 2nd shift hours. We’re seeking a meticulous Data Reviewer to join a leading team in analytical quality assurance. This role is pivotal in maintaining the integrity of analytical data for pharmaceutical products through thorough documentation and adherence to regulatory guidelines. The ideal candidate thrives in a detail-oriented environment and brings a strong understanding of cGMP standards and pharmaceutical laboratory processes. Evaluate analytical test data for raw materials, in-process samples, finished products, and stability samples. Review documentation from laboratory analysis using HPLC/UPLC, GC, KF, and other analytical techniques per in-house and USP monographs. Ensure compliance with cGMP and SOPs in all data review activities. Audit laboratory notebooks, data files, and electronic records for accuracy and regulatory compliance. Collaborate with chemists to ensure timely documentation corrections and compliance. Support regulatory inspections and internal audits by preparing relevant documentation and data sets. Investigate Out of Specification (OOS), Out of Trend (OOT), and other quality events. Provide training and guidance on best practices for lab data recording and review. Bachelor’s degree in Chemistry or a related scientific field. Minimum of 4 years experience in a cGMP pharmaceutical environment. Proficient in analytical instrumentation such as HPLC, GC, and Dissolution testers. Strong understanding of regulatory expectations (USP, ICH, FDA). Experience reviewing raw data, audit trails, and electronic data systems. Standard office and laboratory environment. We are committed to creating an inclusive and diverse work environment and welcome applications from all qualified candidates regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status.
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