Company: Renaissance Pharmaceuticals
Posted on: October 5, 2019
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.
- Review and write deviation reports, change controls, product
complaints, and standard operating procedures.
- Implement new chemical component/packaging component
- Interact with other departments to address/review
- 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,
- 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
- 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
- Any other tasks as requested by management.
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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