Quality Control Scientist

Onsite: Marlborough, MA

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 Masters degree in biotechnology or related field with 5+ years of Quality Control experience.

2) Knowledge of GMP, SOPs and quality control process

3) Experience in the biotech and/or pharmaceutical industry.

4) Ability to work

Pay rate is $35 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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