7682 Sr. Quality Assurance Specialist

Duties:
The External Quality Senior Sr Specialist is responsible for quality oversight for the production of clinical and commercial fill and pack manufacturing processes related to the Contract Manufacturing Organizations (CMOs) and release of lots.
The Sr Specialist interacts with GEO, CMO, Quality Control, Regulatory Affairs, Planning/Supply Chain and CMC.

Skills:
Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.
Support development of commercial and clinical GMP systems at the Company.
Assist with driving implementation of a science and risk-based Quality Culture throughout the External Quality team.
Provide quality oversight of external commercial and clinical CMO’s for those products and services as licensed by the HPRA and FDA, as supervisory authority.
Provide quality oversight of one or more portions of operations including, but not limited to; review of documentation, change requests, batch record and associated documentation review, deviation/CAPA review, and lot release. This involves coordination with other groups such as supply chain, CMO, CMO Pack Ops, etc.
Work directly with the Company CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure lots are released to meet supply requirements.
Conduct lot assessments for product complaints.
Assist with QA decision, direction, and leadership in assigned interdepartmental meetings.
Assist with regulatory inspections.
Implement continuous process improvements.
Other duties as assigned.

Education:
3-5 Years Exp with Degree.