Compliance Specialist

Summit, New Jersey
Industry: Business Analyst / Project Manager
Job Number: JN -062021-65077

 Purpose and Scope of the Position

  • The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multiuse sites through interaction with internal team members and peerlevel customers as well as external service providers. The incumbent in this individual contributor role ensures the compliance of equipment and the ECQ group with local, global, and regulatory guidelines. The incumbent will perform periodic reviews of equipment, policies and procedures, gap analysis where required, and small-scale projects to complete departmental objectives.

Ideal candidate has the following min experience:

  • BS in Engineering or Science related discipline.
  • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
    • Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • 3. Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  • 4. Strong attention to detail.
  • 5. Ability to organize and present data and findings clearly.
  • 6. Possess experience with investigation

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