Conduct routine and non-routine analyses of in-process materials, raw materials, environmental/water samples, finished goods and stability samples by appropriate biochemical methods as assigned by supervisor.
Perform routine QC responsibilities as needed.
Apply acceptable cGMP practices during execution of all work tasks. Work independently with moderate supervisory guidance.
Perform routine QC responsibilities as assigned by supervisor such as (as applicable):
Conduct routine and non-routine analyses of test articles as assigned by supervisor by appropriate biochemical methods such as: SDS-PAGE, HPLC,CE SDS, ELISA, Cell Based Bioassay, etc.
Demonstrate initiative to perform routine QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed.
Monitor laboratory equipment for temperature and conformance to specifications.
Apply acceptable cGMP practices during execution of all work tasks.
Work independently with minimal supervisory guidance. Exhibit strong teamwork skills.
Update supervisor of progress at scheduled intervals. Seek additional guidance as needed.
Use scientific expertise to provide assistance for troubleshooting, laboratory investigations and problem resolution. Suggest process improvements to QC management.
Perform assay data review.
Perform independent assignments such as:
Compile data and prepare graphs for documentation of test procedures and preparation of reports.
Conduct document reviews, author standard operating procedures (SOPs), and assay review.
Lead special projects such as method validation, troubleshooting, optimization, and investigations.
Education and Experience:
BS requires 3-5 years and MS requires 1-3 years of previous related experience.
Good working knowledge of cGMP regulations is required.
Ability to work independently with moderate supervisory guidance.
Excellent teamwork and communication skills. Attentive to detail. Good computer skills.