Overview
QC Data Reviewer Jobs in Massachusetts, United States at United Pharma Technologies Inc
Title: QC Data Reviewer
Company: United Pharma Technologies Inc
Location: Massachusetts, United States
Job Title: QC Stability Data Reviewer
Location: Massachusetts
Job Summary
We are seeking a QC Stability Data Reviewer with 3+ years of experience reviewing stability
data for biologics in a GMP-regulated environment. The ideal candidate will have hands-on QC
laboratory experience, a background in stability testing, and strong expertise in analytical data
review, stability report writing, and cGMP documentation.
Key Responsibilities
- Review and approve cGMP analytical and stability data for accuracy, completeness, and
- compliance with SOPs, specifications, and regulatory requirements.
- Prepare stability data summaries, trend analyses, and technical reports.
- Review analytical results generated using ELISA, HPLC/UPLC, electrophoresis, spectroscopy,
- and compendial methods.
- Verify raw data, calculations, chromatograms, and laboratory documentation while
- ensuring GDP and Data Integrity (ALCOA+) compliance.
- Support OOS/OOT investigations, deviations, CAPAs, and inspection readiness activities.
- Perform data trending and analysis using JMP or similar statistical tools.
- Collaborate with QC, QA, Analytical Development, and Manufacturing teams to resolve
- analytical issues.
Required Qualifications
- Bachelors degree in Chemistry, Biology, Biochemistry, Biotechnology, Pharmaceutical
- Sciences, or related field.
- 3+ years of QC Stability Data Review experience in the biopharmaceutical industry.
- Biologics experience is required (small molecule experience will not be considered).
- Recent hands-on QC laboratory experience preferred.
- Experience with stability testing, followed by data review and stability report writing.
- Strong knowledge of cGMP, GDP, FDA regulations, and Data Integrity requirements.
