JVT Advisors

Sr. Specialist, QC Compliance

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6 months

Job Summary:  This person will be responsible for and involved in various aspects of QC compliance including inspection readiness activities, quality systems, training and document control.  

  • Lead and oversee the QC area inspection readiness program, performing routine walkthroughs and area reviews; provide feedback on compliance gaps and recommend plans for correction.
  • Identify areas within QC for continuous improvement, propose compliant solutions and independently implement.
  • Author and/or participate in QC related deviations, OOS investigations and lab events.
  • Lead and/or participate in the implementation of meaningful and effective corrective actions for deviations, OOS investigations and lab events.
  • Work with the QC Review and Document Control teams to ensure all laboratory testing and support documentation is reviewed, closed out and archived within appropriate timeframes per established procedures.
  • Revise QC SOPs, forms, work instructions and other documentation as required to ensure clarity of procedures, appropriate level of instructions and compliance to regulatory requirements.

  • Minimum 5-8+ years of QC and/or QA experience in a pharmaceutical cGMP setting.
  • B.S. degree in relevant scientific discipline.
  • Excellent technical writing skills and experience authoring deviations, investigations, and procedures in a cGMP setting.
  • Knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Excellent ability to communicate in a scientifically sound and understandable manner.
  • Demonstrated ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment effectively and independently.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Ability to navigate through ambiguity and rapid growth and adapt to change.

Jared Potter

Principal Recruiter

He's a natural people person.

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