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QS Specialist

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: October 5, 2019

Job Description:

Overview

The Quality Systems Specialist is to maintain and coordinate Quality Systems related documents namely deviation reports, change controls and product complaints for compliance with cGMP and company procedures with minimal supervision. To review and write cGMP procedures under supervision. To process changes in analytical methods, test specifications and batch records. To issue effective documents including procedures, forms, reports, and analytical methods. To process changes to the procedures. To report periodic quality metrics and perform trending of data.

Responsibilities

  • Review and write deviation reports, change controls, product complaints, and standard operating procedures.
  • Implement new chemical component/packaging component specifications.
  • Interact with other departments to address/review observations.
  • Maintain all quality management systems and provide training where applicable. (i.e. Documentum; Trackwise Complaint; Trackwise Change Control; Trackwise Technical Communication; Trackwise Deviation; Order Tracking; QIS; Stability System - Scientek; DCN; BarTender; Batch Record Issuance; Logbook Issuance; Einfo Tree, Archive)
  • Perform gap analysis of all quality related procedures to ensure there are no gaps present
  • Lead process improvements and projects within the company.
  • Generate work flows for creation, revisions, review, approval and implementation of procedures, form, batch records, and methods using electronic systems as documentation.
  • Issue effective documents including procedures, forms, reports, analytical methods, batch records and logbooks.
  • Ensure documents are effective at all times.
  • Review documents for compliance with company standards for formatting, review, approvals and implementation.
  • Create and maintain procedures for document work flow, document retention, archiving and retrieval.
  • Assist with document retrieval during audits.
  • Coordinate assignment of procedures effective dates with training department.
  • Interact with departments to ensure timely revisions and approvals of the documents.
  • Provide training in Quality Systems to ensure effective use of the systems Trackwise, Documentum, QIS, and DCN.
  • Maintain and report quality metrics and trending of data.
  • Act as administrator of electronic system used for Quality functions.
  • Any other tasks as requested by management.

    Qualifications

    Bachelor's degree required or equivalent work experience. Prefer at least 2 years of relevant experience in the pharmaceutical industry and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.

Keywords: Renaissance Pharmaceuticals, Lakewood , QS Specialist, Other , Lakewood, New Jersey

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