Quality Control Scientist
33 Locke Drive Marlboro, MA 01752 US
Job Description
PURPOSE & SCOPE: This position provides Quality Control testing of in process and final product testing. Looking for experience with cell culture, RT-qPCR, Immunofluorescence, cell based assays etc. this is an onsite role
ESSENTIAL JOB RESPONSIBILITIES:
1) Perform routine in-process and release QC testing of cell products.
2) Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.
3) Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
4) Track and test products according to stability protocols.
5) Work with internal and external resources to maintain lab in an optimal state.
6) Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
7) Develop, revise and review SOPs, qualification/validation protocols and reports.
8) Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
9) Monitor the GMP systems currently in place to ensure compliance with documented policies. Perform other lab duties as required.
REQUIRED:
1) Bachelor or Master's degree in biotechnology or related field with 5+ years of Quality Control experience.
2) Knowledge of GMP, SOP?s and quality control process
3) Experience in the biotech and/or pharmaceutical industry.
4) Ability to work weekends.
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Marlboro, MA
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.