Experience:
3-5 years of experience
Concerned about your lack of experience? Learn More...
Employment Type:
Full time
Posted:
2/14/2020
Job Category:
Other
QS Specialist
(This job is no longer available)
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Job Description

QS Specialist

Bachelor's degree required or equivalent work experience

Entry level - no experience required. Prefer at least 2 years of relevant experience in the pharmaceutical industry and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.

Responsibilites:

QS Specialist will 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 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.

Location: Lakewood

Duration: Temp

About Precision Resource Company

Precision Resource is one of the world's largest precision metal component suppliers using fineblanking technology - with six strategically located facilities in North America and more fineblanking presses (130+) than any other company in the world! We service our customers with press sizes ranging from 40 tons to 1400 tons and with a tremendous range of secondary processing capabilities. These additional capabilities include grinding (double-side, single-side, and fine grinding), lapping, CNC machining, assembly, forming, and heat treating. Precision Resource's customer base consists of an international list of recognized leaders in industries such as automotive, electronics, off-highway equipment, cutlery, hand tools, hardware, lawn & garden equipment and many more. This combination of production capabilities and a demanding and diverse customer base helps ensure that Precision Resource remains the modern, progressive manufacturer that we are so proud to be.