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Job Title: APR
Category:  Professional & Business Operations
  • The APQR Specialist is responsible for ensuring ongoing QA compliance functions are met relative to APR/PQR with the primary function of compiling, organizing, analyzing and approving information for the APRs for products manufactured or packaged by CMOs.
  • The APQR Specialist will assist in the circulation of the completed APR for review and approval.
  • The APQR Specialist will draft the management summary statement for the Annual Product Reviews (APRs) and Product Quality Reviews (PQR).
  • The APQR Specialist will provide support to Regulatory Affairs in collection of chemistry, manufacturing, and controls (CMC) data from Contract Manufacturing Organization (CMO).

  • BA/BS degree in science or health related field required.  Advanced degree preferred.

  • Knowledge of medical device and/or drug GMP’s required. 

  • Must have excellent communication, organization, time management and writing skills.  Strong interpersonal skills required in areas of verbal and written communications, service to internal customers, professionalism, coaching, influencing and team building.  Strong questioning and problem-solving skills. 

  • Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures. 

  • Ability to write routine reports and business correspondence. 

  • Ability to effectively present information in one-on-one and small group situations to internal customers and other employees of the organization.  Ability to communicate well with all levels of the organization. 

Location  Bridgewater , NJ
Minimum Experience (yrs):  3+
Required Education:  Not Specified

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