Quality Assurance Manager

1 week ago


Amarillo, Texas, United States KEDPLASMA LLC. Full time
Job Description

KEDPLASMA LLC. offers a dynamic and rewarding work environment with opportunities for growth and development. We are committed to providing a safe and inclusive workplace for all employees.

Key Responsibilities:

1. Oversee all activities related to product quality, ensuring compliance with state, federal regulations, industry, and corporate policies.

2. Collaborate with Center Manager to ensure product quality and coordinate, monitor, and facilitate all QA activities.

3. Ensure production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP's (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.

4. Review and investigate final shipment release deviations, including accurate labeling and documentation of shipments.

5. Determine that DCOP's exist for all manufacturing procedures, including testing, and that DCOPs accurately describe and define the procedure, including a statement of what the procedure is intended to accomplish.

Benefits:

KEDPLASMA LLC. offers a comprehensive benefits package, including medical, vision, and dental insurance, life and AD&D insurance, paid holidays, PTO accrual, and more.

Requirements:

Relevant experience, education, and certifications will be considered in determining salary ranges.



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