Senior Quality Assurance Auditor (GMP)

Senior Quality Assurance Auditor (GMP)
MON-03832
Ohio Manufacturing Facility



Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

 

Currently, we have a great opportunity for a highly motivated, hands-on professional to assume responsibility for all project management and leadership functions to support the quality compliance area and quality initiatives.

 

Coordinate and conduct local, site-specific audits and inspections to ensure regulatory quality compliance by performing the following duties:

 

• Conduct on-site self-inspection activities, which include: initiation and execution of the audit, generation of the final report and recommended corrective actions, review of corrective action plans and closure of follow-up activities

• Maintain master internal audit schedules and quality audit files for on-site regulatory activities, specific to the Ohio manufacturing facility

• Evaluate and/or initiate employee training for Standard Operating Procedures on auditing practice and the audit corrective action program

• Interpret Food and Drug Administration (FDA) regulations and comparable international regulations, Standard Operating Procedures, and other company policies and procedures on regulatory compliance

• Maintain a detailed understanding of current regulatory requirements

• Assist with, and support as a resource for, regulatory inspections of Amylin Ohio LLC

• Provide and implement effective solutions to quality issues or problems

• Develop subject matter expertise with the CAPA programs on site

• Generate quality system metrics and presentations to senior management

• Support complaint investigations which require follow-up and evaluation by the Ohio manufacturing site with the coordination of site responses for proposed corrective and preventive action for complaints

• Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures and appropriate industry and regulatory standards, guidelines, rules and regulations.

 

This position requires:

 

• A BA/BS in a scientific discipline

• 7 years of directly related audit experience in a pharmaceutical environment

• A detailed understanding of FDA and international guidelines such as EU

• Strong working knowledge of GMP regulations

• Excellent interpersonal skills

• Certified Quality Auditor or similar certification is highly desired.

 By “Challenging Science,â€� Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Livesâ€� for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.





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AMYLIN

Challenging Science. Changing Lives.