Quality Associate/ Sr. Quality Associate Materials Evaluation Coordinator

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Quality Associate/SR QA Associate Materials Evaluation Coordinator

Hours:  Day Shift

 

Position Summary:

The Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator performs in the Packaging area as a Quality representative for sampling, auditing, and making Quality decisions.  In this area, the Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator audits unlabeled final container vials, media, syringes and finished product batches using designated ANSI sampling plans. 
Additionally, the Packaging Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator responsibilities include:  reserve sampling, post-pack identity sampling, packaging commodity verification and
reconciliation, line clearance verification, and stability sample inspection. The Quality Associate/Sr. Quality Associate Materials Evaluation Coordinator inspects product final container reserve samples according to approved standard operating procedures. Decisions made by Quality Associate/Sr. Quality Associate Materials Evaluation Coordinators have major compliance and monetary implications for Grifols. 

 

Primary Responsibilities:

• Evaluate critical quality attributes (visual, dimensional, functional), of unlabeled final containers and finished product, and execute required SAP transactions on all quality audits of material inspected and packaged at the facility.
• Must stay abreast of the rapidly changing requirements of various regulatory agencies.  New policy changes from these groups has a definitive, immediate impact on Materials Evaluation responsibilities and release of material to production.
• Responsible for performing quality verifiation of component issuance, vial etch, production order picklists of products packaged at the Clayton site. Non-verification of primary and secondary packaging components could be means for material or plasma product recall and will impact product market availability.
•  Must possess extensive knowledge of cGMP, company specifications and packaging operating procedures.
• Quality Associate/ Sr. Quality Associate Materials Evaluation Coordinator will serve as trainers to new employees in all aspects of this position and are considered to be a Subject Matter Expert (SME).

 

Knowledge, Skills & Abilities:

The incumbent must possess keen assessment skills and the ability to distinguish insignificant deviations from significant deviations that jeopardize the integrity of the product to be released. The incumbent must be able to learn and understand the concepts of statistical sampling used in daily activities. Computer skills are required. Must be able to read and understand technical drawings.  Effective communication skills, including proper grammar, are essential in order to report (both in writing and verbally) data and product impact. Must keep neat, accurate, and complete records of material evaluations and release activities performed. Tactful human relation’s skills are essential to achieve cooperation between business partners and customers.

Incumbent must have prior inspection experience (i.e. manufacturing components, packaged goods, etc.)

 

Education:

Requires minimum of an Associates degree with an emphasis in sciences or mathematics or an equivalent combination of education and experience is acceptable.

 

Experience:

A minimum of one year of related experience, preferably as a packaging inspector or in Materials Evaluation, is required for the Quality Associate/ Sr. Quality Associate Materials Evaluation position.

Incumbent must have prior inspection experience (i.e. manufact