Sr. Quality Assurance Auditor (AMLN-01833)

Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development, and commercialization of innovative, cost-effective medicines. Our rapid growth has created the following outstanding opportunity in San Diego, CA:

 

Sr. Quality Assurance Auditor

(AMLN-01833)


In this role, the successful candidate will coordinate and conduct audits and inspections to ensure regulatory quality compliance. This will involve conducting, or coordinating through outside firms, comprehensive cGMP investigations and follow-up audits of internal operations and applicable contract service providers, such as manufacturing sites, analytical laboratories, and packaging/labeling vendors. Auditing activities 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. Other duties include overseeing and tracking any audit activities performed by outside consultants.

 

Responsibilities:Maintain master internal and external audit schedules and quality audit files for regulatory activities.Provide and/or coordinate applicable required regulatory compliance training of employees at all levels, in collaboration with the Quality Assurance Training Coordinator. Evaluate and/or initiate employee training for SOPs on auditing practices.Interpret FDA regulations and comparable international regulations, SOPs, and other company policies and procedures on regulatory compliance. Maintain detailed understanding of current regulatory requirements.Assist with, and as a resource for, regulatory inspections for Amylin and contractors.Provide and implement effective solutions to quality issues or problems.Ensure comprehensive quality system meets regulatory requirements. Write or update quality manual(s), policies and SOPs describing applicable audit practices and related compliance activities. Update or develop processes and workflows, as necessary.Maintain a DMV driving record in accordance with Amylin?s fleet and automobile requirements.

 

Requirements:BS in a scientific discipline and 5 years directly related audit experience in a pharmaceutical environment. Requires detailed understanding of FDA and international guidelines such as EU. Requires a strong working knowledge of cGMP regulations. Understanding of GLP / GCP is helpful. Certified Quality Auditor or similar certification is highly desirable. Candidate must display strong interpersonal skills.Up to 40 percent travel.

 

Amylin offers competitive compensation, benefits and stock options.  Amylin maintains a drug and alcohol free workplace and all offers of employment are contingent upon satisfactory completion of a pre-employment drug and alcohol test. Please apply online at: http://careers.amylin.com  AA/EEO Employer.

 

Amylin

 Pharmaceuticals