Senior Specialist, Quality Systems

4 weeks ago

Raritan, New Jersey, United States Johnson and Johnson Full time

We are seeking a highly skilled Quality Systems Specialist to join our team at Johnson & Johnson. In this role, you will independently perform Quality Systems activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.

Key Responsibilities:

  • Provide support and robust guidance for Quality Systems, including document management and metrics reporting.
  • Ensure compliance to the Quality Systems procedures and policies.
  • Actively participate in global super user network meetings and communicate relevant information to the team/site.
  • Review wide variety of documents for compliance to procedures, including SOPs, Work Instructions, Technical Documents, Logbooks, Forms.
  • Drive alignment and efficiencies between global and local processes.
  • Provide quality input on quality systems related issues and represent department in meetings.
  • Coordinate and conduct Quality Systems Review meetings.
  • Support internal and external audits, inspections, pre-inspection readiness, certifications, tracking, and trending activities.
  • Work closely with management and various team members to propose and complete improvements activities.
  • Ability to respond swiftly to departmental and interdepartmental requests.
  • Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.

Requirements:

  • Minimum of a Bachelor's degree is required with a focus in Biology, Engineering, Science, or equivalent technical subject area is preferred.
  • A minimum of four (4) years of experience in Quality Systems, Quality Assurance, Quality Control, Validation or Engineering in pharmaceutical industry, across various roles.
  • Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness, and adaptability.
  • Ability to work on complex issues with minimal direction and think analytically.

Preferred:

  • Familiarity with Quality Event Management systems (Trackwise, COMET, or equivalent systems).
  • Project Management skills.

Additional Information:

  • Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice.
  • Requires up to 10% domestic travel.
  • The anticipated base pay range for this position is $76,000-$121,900.
  • The Company maintains highly competitive, performance-based compensation programs.

We are an equal opportunity employer and welcome applications from diverse candidates. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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