This growing team is looking to proactively add to their QC team as the upcoming portfolio and pipeline is getting better. They are looking to start and train a contractor with an opportunity to convert to a full time employee during the contract.
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.
location: Marlborough, Massachusetts
job type: Contract
salary: $45 - 60 per hour
work hours: 8 to 4
ESSENTIAL JOB RESPONSIBILITIES:
- Perform routine in-process and release QC testing ofcell products.
- Execute analytical method validations and transfers including drafting technical protocols, reports and troubleshooting.
- Maintain, calibrate and operate equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assays.
- Track and test products according to stability protocols.
- Work with internal and external resources to maintain lab in an optimal state.
- Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Perform other lab duties as required.
- Bachelor or Masters degree in biotechnology or related field.
- 1 - 2 years of Quality Control experience.
- Knowledge of GMP, SOPs and quality control process
- Experience in the biotech and/or pharmaceutical industry.
- Ability to work weekends.
skills: Quality control, Cell Biology, PCR, SOP, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.