QC Data Review Specialist (6 month contract)
Bristol, PA, US
Scientific
Bachelors Degree
Full Time, Temp to Hire
$48-57/hour
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Bristol, PA, US
$48-57/hour
Experienced (Non-Manager)
Full Time, Temp to Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Kelly Science is seeking a QC Data Review Specialist to join a growing team located in Bristol, PA.
This position is 100% on-site.
Pay: $48-57/hour depending on experience
Shift: Monday – Friday 9:00am-5:00pm OR 10:00am-6:00pm
Employment Type: Full Time; 6 month contract
Job Responsibilities:
- Review GMP QC analytical data generated by the Analytical Services team, ensuring accuracy and compliance with established standards.
- Review and interpret data from separation-based assays (e.g., HPLC, CE-SDS), and support the batch analytical foundation by coaching team members, identifying analytical issues, and proposing corrective solutions.
- Apply ALCOA+ and data integrity principles during all data review activities to maintain the highest standards of quality and compliance.
- Support and contribute to deviation review and investigation activities, helping identify root causes and implement effective corrective actions.
Qualifications:
- Bachelor’s degree in Chemistry or a scientific related field
- Minimum of 8 years GMP analytical experience with HPLC, CE-SDS and GC.
- 1–2 years focused on data review would be strongly preferred.
- Experience with CIEF and wet chemistry/compendial methods is a plus.
- Demonstrated expertise in operating analytical instruments, method validation (both drafting and approving protocols/reports), and thorough data review.
- Strong experience with Empower software required. Must possess the ability to deep-dive into account-level data for compliance and data integrity review.
Interested? Please apply today for immediate consideration!
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