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location: Marlborough, Massachusetts
job type: Temporary
salary: $40 - 48 per hour
work hours: 9 to 5
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
- Perform routine in-process and release QC testing of cell 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 Master's Degree in biotechnology or related field with 5+ 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: PCR, SOP, Flow Cytometry, GMP (Good Manufacturing Practice)
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
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.