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.
- 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 21stcentury 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.