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Title: Sr. Specialist, Quality Assurance

Location: Boston, MA Seaport district

Hybrid; 3 days a week onsite, 2 remote

Status: contract through end of year

Hourly rate: $58


This Quality Assurance role requires experience in biotech and biologics. Only candidates with this experience will be considered.


Candidates must reside in Massachusetts.


The Sr. QA Specialist will be responsible for supporting GMP QA processes, including master and executed batch record review and disposition of drug substances and drug products (including package and labeling). The positions is also responsible for owning and supporting deviations, change control, and CAPA‘s. This role will contribute to development of the internal Quality Management System (QMS) and support other internal QA functions including training, documentatio0n, This role is based in Boston, MA and reports directly to the Director of GMP QA.


Required skills

  • Review and approve Master and Executed Batch Records.
  • Review in-process, release, and stability data.
  • Disposition lots from intermediates through finished drug product.
  • Supports internal and external deviations, change control, and CAPA.
  • Supports Vendor Management Program, including management of vendor audit activities and the Approved Supplier List.
  • Writes and implements changes to Standard Operating Procedures.
  • Coordinates and reviews change control activities to drive change control records to closure.


Qualifications

  • 7+ years of experience in chemistry, biology, or related scientific or engineering field.
  • Experience supporting GMP and CMC functions from QA perspective is required.
  • Strong attention to detail and ability to communicate and collaborate with stakeholders outside of Quality.
  • Authoring and reviewing SOP’s.
  • Based in the Boston area with ability to come into the office 3 days.