Job Description
DUTIES: Supervise a team of QA specialists to achieve manufacturing project deliverables and milestones.
Coordinate and communicate project timelines and activities with core team.
Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, and Reports. Lead technical discussions with clients at project level with a high level of technical proficiency.
Interact with clients, resolve project escalations, and support team with client interactions.
Draft technical plans, reports, and protocols.
Compile and review batch release documentation packages.
Provide Quality expertise and oversight of the batch disposition process.
Work with manufacturing and cross-functional team members to ensure deliverables are met to support disposition of the batch.
Ensure business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.
Support Manufacturing and Testing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
Travel: Up to 5% domestic travel required.
REQUIREMENTS: Master's degree in Industrial Engineering, Chemical Engineering, Biochemistry, or related field of study and 3 years of experience in manufacturing quality control, quality assurance, or related experience. Employer will also accept a Bachelor's degree in Industrial Engineering, Chemical Engineering, Biochemistry, or related field of study plus 5 years of related experience with manufacturing quality control, quality assurance, or related experience. Required knowledge or experience with:
•Technical writing;
•Deviations;
•CAPAs;
•Change control;
•Reviewing quality records;
•Project management;
•Quality assurance;
•Quality control;
•cGMP compliance.