Quality Assurance Associate

Cangene Corporation has an immediate opportunity for a QA Associate at their plasma collection center in Frederick, Maryland.

Duties include:

Ensure compliance to center procedures and all applicable regulatory requirements as defined by FDA, MHRA, Health Canada, Customer specfications and other quality/regulatory bodies.

 

Work as part of a team with Center Management, Corporate QA, RA and Plasma Operations to ensure safety of donor and products. 

Ensure compliance with Quality Policies and Standard Operating Procedures, including:
? Conducting internal and external quality audits
? Maintaining quality systems, including deviation and corrective action management, document control and tracking & trending systems.

? Conducting quality reviews of all plasma center records, including donor files, equipment, supplies and training records.

? Hosting regulatory inspections and audits

?100% label verification and QA release of all product shipments.

.Participation in training, including GMP training of all staff.

Qualified candidates will have a college degree or equivalent experience/knowledge directly related to plasmapheresis collections, immunization programs, blood banking, or clinical laboratory science with training in GMP regulations. Excellent written, verbal and interpersonal skills are required.