Quality Auditor

Quality Auditor

Contact Information: Sunrise Systems Inc PO BOX 4647 Metuchen, NJ 08840	View other jobs with this company
	Contact: Phone: Fax:	Manisha Subramanian 732-603-2200 732-603-2208

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Reference Number:
QualityAuditor-PA

Job Description:
Our major pharmaceutical client is looking for a Quality Auditor for a 6+ month position in West Point, PA.

Position Description:
- Under the direction of GMPQ supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs)And other applicable worldwide regulations.
- Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
- In addition, the Auditor communicates and resolves audit comments with client areas.
- Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Merck standards.
- Issue reports summarizing deficiencies and work with areas to execute remedial action.
- Notify appropriate management of inspection results.

Requirements:
- B.S. and/or M.S. in an appropriate Science or Engineering discipline.
- Minimum of 1 year of experience required with a B.S. Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
- Effective communications (oral/written) and interpersonal skills are necessary.

Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "QualityAuditor-PA" IN THE SUBJECT LINE!

Experience Level:
Unspecified

Requirements:

Location:
West Point PA

Duration:
6 - 9 months

Pay Rate:

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Date Posted: 11/18/2009
Last Updated: 11/18/2009
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