Senior QA Associate I,II - Contract Manufacturing
Job Type:
Regular Full-Time
Location:
Research Triangle Park, NC
Job Description:
Dendreon is seeking a highly motivated Senior QA Associate, to be located in our North Carolina office, as part of our Quality Assurance Contract Manufacturing team. Dendreon is 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, which will develop and implement Quality Assurance policies and procedures in support of commercial manufacturing of Dendreon’s Active Pharmaceutical Ingredient.
General Summary:
Review and disposition contractor batch records promptly and effectively.
Provides on-site quality oversight at contract manufacturer.
Tracks and trends deviations, non-conformances, corrective actions, OOS, change controls, investigations and other metrics in support of management review.
Provides support in the review and approval of change controls related to materials management.
Works effectively to support all QA groups, providing assistance in performing data audits, processing deviations, non-conformances and CAPAs.
Writes and reviews Standard Operating Procedures proactively, working with others to develop solutions.
Develops and reports Quality metrics related to contract manufacturing sites.
Maintains awareness of regulations (cGxP, CFR) and industry standards (USP, ICH, FDA guidance), ensuring Dendreon Quality is always aware of and addresses changes/revisions.
Job Requirements:
Bachelor’s degree in a scientific discipline or equivalent.
Typically 5 years related experience in cGMP/FDA regulated industry (protein manufacturing preferred).
Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.
Proficient in MS Office applications.
Working Conditions and Physical Requirements:
Ability to gown aseptically for work in Clean Room environments.
May be required to work alternate shifts and extended hours to meet project timelines.
Some travel may be required to other Dendreon sites.
This position is located full time at our North Carolina office.
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.