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Associate II, Quality Control (Bioassay)

Location
Norwood, Massachusetts
Job Type
Permanent
Posted
13 Sep 2020
Title: Associate II, Quality Control (Bioassay)
Location: Norwood, MA
Duration: 5-6 months+

Description:
  • The individual will execute methods including, but not limited to, Agarose Gel Electrophoresis, UV/Vis measurement, Sanger Sequencing, protein concentration determination and qPCR. This position will contribute to related method transfers and qualification activities.
  • This position will be 1st shift from 7:00 am to 5:00 pm Wednesday to Saturday.
  • Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, but also supporting ELISA, Cell-Based Potency testing, and other methodologies as needed
  • Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies?
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements?
  • Perform general laboratory support activities including reagent preparation, equipment maintenance, etc
  • Write/revise SOPs, protocols and reports
  • Provide support to audit teams for internal and vendor audit
  • BS in a relevant scientific discipline with at least 2 years Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing
  • Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, etc.
  • Understanding of Sanger Sequencing
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred
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Details

  • Job Reference: 173892724-2
  • Date Posted: 13 September 2020
  • Recruiter: Integrated Resources, Inc
  • Location: Norwood, Massachusetts
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent