Quality Control Specialist

  • location: Marlborough, MA
  • type: Contract
  • salary: $45 - $60 per hour
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job description

Quality Control Specialist

job summary:
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
education: Bachelors
 
responsibilities:
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.
 
qualifications:
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.

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