Pharmaceutical Senior QA and QC Specialist - Group Leader

This position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification, QC protocol, reports, QC process control document, new and existing procedures, and Quality Control deviation/investigations. Supports process improvements implementation. This role is in Sanford, NC.

POSITION RESPONSIBILITIES:

• Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.
• Provide final QA approval on simple change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
• May also review and approve documents such as Deviation, complaints investigations, Laboratory investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build of Master Batch or any electronic record when needed, and all associated to compendial changes.
• Capable to Make quality decisions in real time according to regulations and procedures. 
• Ability to work collaboratively with internal partners to resolve technical issues.
• Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.