QA Compliance Specialist

Proclinical is currently recruiting for a QA Compliance Specialist with a pharmaceutical company located in Burlington, MA. This individual will be responsible for organizing and coordinating the Supplier Quality and Audit program. Responsibilities include overseeing compliance-related initiatives, such as the internal auditing program, as well as external audits, approved supplier lists, quality agreements, and annual product reviews.

Job Responsibilities:

• Responsibilities include the development of an annual schedule, coordinating internal and supplier audits, and reporting on internal and supplier audit schedule adherence
• Oversee the internal and supplier auditing program
• Implement Global policies pertaining to supplier qualifications
• Support external audits (regulatory bodies and client audits) on an as-needed basis in the front room
• Responsibilities may include Hosting external audit and/or managing and coordinating the war room activities
• Management of supplier and client Quality agreements and drafting Annual Product reviews as required
• Must be able to function independently or in a larger cross-functional group
• Must be detail-oriented, able to work in a fast-paced environment, complete assignments within department cycle times and maintain a high level of quality detailed documentation
• Responsible for tracking metrics for the Quality department and presenting to management
• Drafting and/or reviewing product complaints and managing on-time closure
• Oversee the implementation for new parts at our location in Burlington

Skills and Requirements:

• Bachelor's Degree in life sciences strongly preferred, or equivalent experience
• 3-5 years of experience in the pharmaceutical industry
• Working knowledge of quality assurance, quality systems, and auditing
• Ability to work semi-independently, and have demonstrated ability to interact with others in a cross-functional environment
• Solid knowledge in FDA regulations, especially the cGMP for the 21^stcentury initiatives as well as global GMP and Eudralex 4
• Strong knowledge in the application of phase appropriate, risk-based principles
• Proficient in Microsoft Office
• Proficient in TrackWise/TrackWise Digital

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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