QA Manager - NJ
Job Type:
Regular Full-Time
Location:
Morris Plains, NJ
Job Description:
Dendreon seeking a highly motivated QA Manager to help build our New Jersey QA team and participate in the preparation of the site for FDA inspection. This is an excellent opportunity for someone to provide leadership in a fast-paced, high-volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position.
General Summary:
The QA Manager will provide leadership and support for the development and implementation of Quality Assurance Policies and Procedures. In addition, the Quality Assurance Manager will provide direct support to the NJ Immunotherapy Manufacturing Facility as described below.
Hiring and supervision of Quality Assurance staff that covers multiple work shifts..
Review and approval of GMP controlled documents including SOPs.
Manages the NJ site Material Review Board.
Issues batch records and labeling in support of immunotherapy manufacturing.
Provides for batch record review and disposition of immunotherapy products.
Performs lot packet review and disposition of raw materials.
Ensures initiation, investigation, and closure of lot related deviations, non-conformances, and CAPAs.
Provides support for the recall of non-conforming materials, investigations associated with product complaints, and biological product deviation reports.
Job Requirements:
Bachelor’s degree in a scientific discipline or equivalent.
Typically 7 years related experience in cGMP/FDA regulated industry.
Typically 3 years leadership experience.
Knowledge of cGMP/QSR and FDA device/drug/biologics regulations is required.
Proficient in MS Office applications.
Experience with ERP and/or MRP systems preferred.
Working Conditions and Physical Requirements:
May be required to work alternate shifts.
Ability to gown aseptically for work in Clean Room environments.
Some travel may be required.
The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.