Previous Job
Previous
Quality Assurance Auditor: Pharmaceutical Batch Records and Log Books
Ref No.: 18-02403
Location: Durham, North Carolina
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:Dental Insurance, Medical Insurance
*6 month contract position with additional opporutnity based upon performance and continued business need*

The company
Our client is a global healthcare company. The Company offers health solutions through its prescription medicines, vaccines, biologic therapies and animal health products. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services and Alliances. The Company's Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers, such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices.

Qualifications:
We need batch records or logbooks reviewers more tailored towards Quality Assurance not Control. You will be reviewing paper and/or electronic batch records, logbooks and other forms for GDP’s, compliance and potential investigations.

B.S. in an appropriate Science or Engineering discipline. Minimum of 2 years of experience required. 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. 

**This is not a lab position**

Responsibilities: 
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.

Pay Rate: $22.00 per hour
Drug and background screenings required


On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.