Sterling Engineering, Inc.
https://cdn.haleymarketing.com/templates/63335/logos/square_logo.png
https://www.sterling-engineering.com
https://www.sterling-engineering.com
USD
36.06
HOUR
true
QC Analyst II
Piscataway, NJ 08854 US
2023-03-08
2023-04-20
Employment Type:
Contract to Perm
Job Category: Chemist/ Lab
Job Number: Na95976112
Compensation: 36.06
Job Description
The QC Analyst will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial novel biologics and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as UV, pH meter, HPLC, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.
Essential Duties & Responsibilities
- Analytical testing to support product in-process, release, and stability programs.
- Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
- Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
- Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
- Performs other functions as required or assigned.
- Complies with all company policies and standards.
Requirements
Education:
Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 4-6 years of experience in a pharmaceutical/biotech QC laboratory. Alternatively, Master’s degree in above areas with 2-4 years of experience in a pharmaceutical/biotech QC laboratory.
Experience:
· Previous experience in a cGMP laboratory.
· Strong background in Large/small molecule and protein chemistry and experience troubleshooting analytical results.
· Demonstrated ability at writing, revising, and complying with SOPs, policies, and QC methods.
Specialized Knowledge and Skills:
· Demonstrated success working with techniques such as UV, pH meter, HPLC, cell-based bioassays, capillary electrophoresis, ELISA, and standard compendial assays.
Work Environment & Physical Demands:
General Working Environment:
- Some time spent in an office doing office work (reading, writing, reviewing, and editing documents).
- Significant amount of time spent in the laboratory.
- Must be able to work extended hours or weekend hours, as may be required.
Noise:
No extraordinary noise levels.
Standing/Lifting:
Must be able to lift at least 25 lbs.
Visual:
No extraordinary requirements.
Stress:
High-paced demanding environment to meet ambitious project goals.
Travel:
No travel required.
