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Scientific Quality Auditor


Please note that this is a 6 month contract assignment. Candidates cannot start an assignment until background check and drug test is completed
Please note that this is a 6 month contract assignment. Candidates cannot start an assignment until background check and drug test is completed
The schedule is dynamic than could be shown. The position rotates as follows: 1st week - 6:30am to 3:00pm 2nd week - 7:30am to 4:00pm 3rd week - 2:30pm to 11:00pm (repeat). The rotation is Monday through Friday with the exception of 1 to 2 Sundays per month are worked 7:30am to 4:00pm with the following Friday off .
Responsibilities:
Under the direction of GMPQ supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations. Review and approve production documentation accompanying the release of drug product 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 standards. Issue reports summarizing deficiencies and works with areas to execute remedial action. Notify appropriate management of inspection results and tracks metrics.

Qualifications:
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.
Responsibilities:
Under the direction of GMPQ supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations. Review and approve production documentation accompanying the release of drug product 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 standards. Issue reports summarizing deficiencies and works with areas to execute remedial action. Notify appropriate management of inspection results and tracks metrics.
Qualifications:
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.

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