Senior QA Compliance Specialist

Edison, NJ 08837

Posted: 06/14/2018 Industry: Quality Assurance/Safety Job Number: 46569

Senior QA Compliance Specialist


Overview:

To coordinate, review, track and report on the deviations that are generated as part of the Nonconformance Systems.  


Responsibilities:
  • Oversees and monitor the open nonconformance’ s to ensure all activities are being completed in a timely manner.
  • Complete an independent review of the nonconformance deviation to assess for level, trend and assign action items as necessary.
  • Complete an independent review of the nonconformance and all related materials, to assess for closure or QAA.
  • Ensure effective corrective actions are put into place as part of a nonconformance closure.
  • Is responsible to lead team meeting to ensure nonconformances are effectively and efficiently completed.
  • Provide training and guidance on the nonconformance system, problem statements, investigations and root cause analysis.
  • Updates and reviews standard operating procedures, work instructions, forms and templates as required by management.
  • Compiles a monthly report on nonconformance’ s to evaluate any trends that shall be escalated for review to management and CAPA Review Board Meeting.
  • Responsible for providing individual or customized reports to any department or management.
  • Responsible for providing reports and documentation to the FDA, internal audit or any other auditing body.
  • Is responsible for issuing new user rights in the nonconformance database and updating current user rights.
  • Assists on special projects and performs other duties as assigned.


Qualifications:

MINIMUM JOB REQUIREMENTS

Education:

Associates degree or 2 years college; science or other related field preferred.  Bachelor' s degree strongly  preferred.

Experience:

3 years quality assurance or FDA regulatory experience

Specific Licenses and/or Certifications:

 

Specialized Knowledge, Skill, and Abilities*:
  1. Fluent in Microsoft Office, specifically Word and Excel
  2. Strong verbal and written communication skills

Work Environment:

Office

Physical Demands:

(if applicable)

Travel up to 20% of the time.

Victoria Gatarz

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