QA Manager (Lexington, MA)

Location: Framingham, Massachusetts, United States
Salary: competitive
Job Type: Contract
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Title: QA Manager
Duration: One year (possible extensions)
Location: Lexington, MA

ACCOUNTABILITIES:

  • Assists with the prioritization and coordination of batch release activities, to prevent supply disruption.
  • Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to requirements and SAP inspection plans.
  • Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into systems e.g. LabLIMS and SAP/BPR
  • Prepare and review batch documentation for release, including upload of batch certificates to the repository.
  • Archive batch documentation according to company and customer requirements.
  • Perform Technical Release of products in SAP/BPR based on release certificates from Contract Manufacturers/ Suppliers
  • Support other functions as needed with e.g. PQR preparation, deviations, change controls, and CAPA.
  • Maintenance of product lists and Quality relevant SAP master data.
  • Provides other support/input as needed to ensure the effective oversight of Contract Manufacturers/Suppliers and compliance of OncESSM procedure/processes with internal requirements, and GMP.
  • Provides Quality oversight for Artwork changes for product manufactured in the US.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
  • Minimum 6 years of QA/QC experience in the pharmaceutical industry
  • Demonstrated teamwork, initiative, and problem-solving skills
  • Fluent in English language oral/written communication skills

SKILLS REQUIRED:

  • Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
  • Analytical Skills - ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
  • Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management
  • Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
  • Regulatory Understanding - broad based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging

Sthree US is acting as an Employment Business in relation to this vacancy.

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