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Senior QA Operations Associate (Contract)

Company: Advanced Clinical
Location: Cambridge
Posted on: February 16, 2021

Job Description:

Senior QA Operations Associate (Contract)Location: Cambridge, MADuration: 6+ months contract
**** Minimum 5 - 6 years experience in a Quality position is REQUIRED ******** Minimum 5 - 6 years biopharmaceutical/industry experience is REQUIRED ******** Experience interacting with internal CMC and external vendors is REQUIRED ****
RESPONSIBILITIES

  • Responsible for QA Operations oversight and support clinical development projects within CMC project teams.
  • Interfacing with both internal CMC teams as well as a network of external vendors.
  • Supporting the activities associated with manufacturing and disposition of clinical and commercial materials including change management, deviations and investigations.
  • Performing lot disposition activities to ensure that materials are released in accordance with regulatory requirements, cGMPs and policies and procedures and within project lead times
  • Interfacing with internal departments and external vendors
  • Reviewing and approving documents necessary to support the program.
  • Contributing to the evaluation and mitigation of program risks and escalation of potential significant quality issues.
    QUALIFICATIONS
    • Minimum 5 - 6 years experience in a Quality position
    • Minimum 5 - 6 years biopharmaceutical/industry experience
    • Ample knowledge of cGMPs
    • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action
    • Experience with Ex-US disposition
    • A combination of Quality and technical experience (development, manufacturing, analytical, validation)
    • Experience building internal and external relationships and working with external vendors
    • Excellent interpersonal, problem solving, skills.
    • Ability to coordinate timelines with internal customers and external clients and vendors.
    • Strong team player and is solution oriented.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Strong written and verbal communication skills.
      EDUCATION
      • B.S. / B.A. or science degree

Keywords: Advanced Clinical, Cambridge , Senior QA Operations Associate (Contract), Other , Cambridge, Massachusetts

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