Data Reviewer III
$76,000–$94,000 year
On-siteRensselaer, New York, United States
Rensselaer, New York, United StatesOn-siteFull Time$76,000–$94,000 yearMid LevelBachelors DegreeHealthcare Tech
Full TimeMid LevelBachelors DegreeHealthcare Tech
Job Summary
Quality Control Data Reviewer III is responsible for reviewing and approving primary analytical data generated in CGMP-compliant labs, including data from GC, HPLC/UHPLC, IR, DSC, UV-Vis, and KF, to ensure data accuracy, completeness, and integrity. The role includes electronic review and signatures, verification of instrument calibration and logbooks, escalation of OOS findings, preparation of Stability summary tables and protocols, data trending, training of new hires, and supporting QA initiatives and client projects in a pharmaceutical manufacturing environment.
Required Qualifications
- Bachelor's Degree in Natural Science, Pharmacy or equivalent
- Minimum 5-8 years' in QC operations or relevant industrial experience
- Experience working in cGMP or GLP pharmaceutical industry environment
- Knowledge, skills and abilities including analytical instrumentation (GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl-Fischer, Dissolution)
- Understand and interpret complex analytical techniques (Method Validation, Method Transfer, Method Verification, Stability testing methodologies)
- Excellent verbal and written communication skills
- Ability to meet deadlines and work under pressure with limited supervision
- Strong time management and organizational skills
- Proficient in Microsoft Office Suite and instrument manufacturer-based systems
- Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
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