Analytical Data Reviewer III
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Role details
Tech stack
Job description
Our confidential client is seeking an Analytical Data Reviewer III to support a fully onsite laboratory data review function in Albany, NY. The ideal candidate will have several years of hands-on experience in a QC, analytical, or testing laboratory, with working knowledge of analytical techniques and instrumentation including HPLC, GC, UV, IR, XRD, and particle-size analysis., * Review and assess laboratory analytical data generated in a regulated laboratory environment to ensure accuracy, completeness, and compliance with applicable procedures and quality standards.
- Apply hands-on knowledge of analytical laboratory techniques and instrumentation, including HPLC, GC, UV, IR, XRD, and particle-size analysis, to effectively evaluate laboratory results and identify potential discrepancies or issues.
- Review analytical data and supporting documentation for adherence to GMP, GDP, ALCOA principles, SOPs, and established laboratory procedures.
- Identify, investigate, and escalate data discrepancies, atypical results, documentation issues, and other technical concerns as appropriate.
- Support technical investigations and problem-solving activities, providing analytical and laboratory expertise to help identify root causes and appropriate resolutions.
- Serve as a technical resource for junior data reviewers and laboratory personnel, providing guidance on analytical data review practices and laboratory techniques.
- Mentor and train junior reviewers or analysts on data review expectations, documentation practices, and applicable laboratory procedures.
- Collaborate with laboratory, quality, and other cross-functional teams to resolve data-related questions and ensure accurate and timely completion of reviews.
- Maintain thorough and compliant documentation in accordance with applicable quality and regulatory requirements.
- Support continuous improvement of laboratory data review processes and practices.
Requirements
- Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Sciences, or a related scientific discipline, or equivalent combination of education and relevant laboratory experience.
- Several years of hands-on experience in a QC, analytical, testing, or other regulated laboratory environment.
- Demonstrated hands-on experience operating or working directly with analytical laboratory instrumentation such as HPLC, GC, UV, IR, XRD, and/or particle-size analysis equipment.
- Experience reviewing and interpreting laboratory analytical data with sufficient technical understanding to assess results, identify discrepancies, and determine when additional investigation is warranted.
- Working knowledge of GMP, GDP, ALCOA principles, SOPs, and regulated laboratory documentation practices.
- Pharmaceutical industry experience strongly preferred; experience in biotech, chemical, or other regulated laboratory environments will also be considered.
- Demonstrated ability to troubleshoot technical issues and contribute to laboratory investigations and problem-solving activities.
- Previous experience mentoring, training, or providing technical guidance to junior laboratory personnel or data reviewers.
- Strong attention to detail and ability to identify inconsistencies or potential data integrity concerns.
- Ability to communicate effectively with laboratory, quality, and cross-functional teams.
- Ability to work fully onsite in Albany, NY., * Bachelor’s (Preferred)
Benefits & conditions
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
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Prepare application
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