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QA Compliance Specialist Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED
Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has five targeted therapeutic oncology candidates in clinical development.Job Responsibilities:
This position is responsible for GxP (GMP, GCP, GLP, GCLP) supplier quality assurance. In this role the employee will be responsible for evaluating suppliers, contract test labs, contract manufacturing organizations (CMO), and contract research organizations (CRO), from a quality perspective. This will include the coordination of supplier self-assessments, assessments of supplier usage conducted internally, as well as coordination and conduct of supplier audits. This individual will also conduct internal audits.
- Lead the QA team in evaluating GxP suppliers
- Coordination of the send out and reconciliation of supplier self-assessments
- Coordination of internal information regarding the current & future use of Suppliers
- Coordinate & schedule Supplier Audits
- Conduct Compliance audits (Suppliers of GMP and GCP services, Internal System)
- Assist with the management of Quality Systems
- Reassess and revise program SOPs as required
-Assist with the management of supplier quality agreements
Requirements:
- BS degree or higher (preferably in Biology or Chemistry)
- Minimum 5+ years QA GMP experience in the pharmaceutical/ biotechnology industry
- Excellent written and oral communication with exceptional organizational skills
- Demonstrated ability to work in a team environment and manage projects independently
- Direct QA Experience with Supplier Management Programs
-3+ Years of GMP Supplier Audit Experience
-3+ Years of supporting GMP Internal Audits
| Location: | One Kendall Square Building 700, Second Floor Cambridge, MA 02139 United States |
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THIS JOB HAS EXPIRED
Merrimack Pharmaceuticals
Investors: Physic Ventures, Unilever Technology VenturesAll Jobs: at Merrimack Pharmaceuticals
| Web Site: | www.merrimackpharma.com |
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| Headquarters: | One Kendall Square Building 700, Second Floor Cambridge, MA 02139 United States |
| Industry: | Biotechnology |
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