QA Compliance Auditor Job

Employer Name: Pharmaceutical Company	SpiderID: 2499160
Location: Lexington, Massachusetts	Date Posted: 10/1/2008
Wage:	Category: Medical/Health
Job Code:
Number Of Openings: 1

Job Description:
· Responsible for GMP audit program to ensure scope, frequency and procedures meet applicable regulations to support company activities.

· Manage the audit program, including the preparation of annual audit plans, the execution of audits (internal and external) according to plan, the preparation of audit reports, tracking audit observations & CAPA to completion and maintenance of vendor files

· Evaluate API, Excipient, Packaging Material vendors and CMOs (which may include contract clinical manufacturing/packaging groups) in support of the vendor qualification program. Track vendor performance and provide reports to management.

· Monitor action plans in response to any regulatory agency or internal audits/inspections to assure timely completion

· Evaluate and improve Quality System programs for compliance to US/EU and other regulatory bodies

· Review and approve appropriate technical documentation in support of cross-functional and cross-departmental projects

· Review and disposition manufacturing, packaging, and testing records from contract manufacturing organizations (CMO’s) for clinical and commercial drug substance and drug product as needed.

· Provide documentation, investigation, change management support etc, to other departments as needed.

· Support the Annual Product Review for commercial products

· Support the Complaint Management program (investigations, follow up, closeout) as needed.

· Perform product lot review/release if needed

· Participate in quality programs and initiatives; make recommendations to continuously improve systems.

· Maintain up-to-date knowledge of regulations, standards and policy

Job Requirements:
· B.A./B.S. in life sciences discipline

· 5-10 years experience in quality assurance and project management experience, with increasing responsibilities, within the pharmaceutical and /or biotechnology industry. Medical Device experience is a plus

· Strong working knowledge and understanding of cGMP regulations; EU regulations a plus

· Experience with regulatory inspections and requirements

· Strong understanding of Quality System regulations and requirements and ability to assess and implement improvements to the existing system

· Excellent oral and written communication skills

· Experience with manufacturing facilities/sites and extensive experience in auditing vendors and CMOs; 3 years experience in management of contract vendors a plus

· Must be able to perform a critical, detailed and accurate review of Quality documentation.

· Strong organization skills

· Ability to write technically accurate and compliant standard operating procedures and reports

· Detail oriented with strength in problem resolution skills with contract vendors

· Ability to interact with diverse departments to initiate and complete projects in a timely manner with minimal supervision

· Strong decision making abilities and a sense of when to involve management

· Good management skills to manage or supervise consultants

Job Criteria:
Start Date:
Position Type: Full-Time Temporary
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel: 25-50%
Vacation Time:

Contact Information:

Contact Name: Justin Endres	Company Type: Recruiter
Company: The Bowdoin Group

City: Wellesley
State: Massachusetts
Zip: 02481

Web Site: http://www.bowdoingroup.com