Quality Assistant/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.

Frist Shift

 

Quality Assistant/Associate Materials Evaluation Coordinator

 

Summary:

The Quality Operations (QO) Assistant/Associate Materials Evaluation Coordinator evaluates critical quality attributes (visual, dimensional, functioncoordinates required chemical and/or biological testing, and executes approved usage decisions on all quality managed material used at the facility These evaluations are performed on a wide variety of materials including, but not limited to, chemicals, labeling components, primary drug containcomponents, process hoses, sterilizing filters, and other critical raw materials. This is done by verifying compliance to specifications and testingrequirements and ensuring required documentation is complete and accurate thus minimizing the possibility that the safety and efficacy of finalproducts manufactured and tested using these quality managed materials is compromised or adulterated. The Coordinators perform the last detailreview of these materials prior to release for use thus sound judgment is essential. The QO Assistant/Associate Materials Evaluation Coordinatorinspects product final container reserve samples according to approved standard operating procedures.

The QO Assistant/Associate Materials Evaluation Coordinator may perform in the Packaging area as a Quality representative for sampling, auditing,making Qualitydecisions.

In this area, the QO Assistant/Associate Materials Evaluation Coordinator audits final product batches using designatedsampling plans.

Additionally, the Packaging QO Coordinator responsibilities include: reserve sampling, post-pack identity sampling, packagingcommodity verification and reconciliation, line clearance verification, and stability sample inspection.

Decisions made by QO Coordinators have major compliance and monetary implications for Grifols.

 

Primary Responsibilities:

• Evaluate critical quality attributes (visual, dimensional, functional), coordinate required chemical and/or biological testing, and execute appusage decisions on all quality managed material used at the facility.
• Issue and track Incidents/Raw Material Reports(RMRs) for discrepant material and quarantine product per approved procedures that governdisposition of such discrepant material.
• Must stay abreast of the rapidly changing requirements of various regulatory agencies. New policy changes from these groups has a definitimmediate impact on Materials Evaluation responsibilities and release of material to production.
  Responsible for reconciliation of all product released (i.e.. Labels, plasma, raw material components, etc.) Non-reconciliation of material coumeans for material or plasma product recall and will impact product market availability.
• Must possess extensive knowledge of cGMP, company specifications and distribution operating procedures.
  Associate QO Materials Evaluation Release Coordinators will serve as trainers to new employees in all aspects of this position and areconsidered 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 jeopardiintegrity of the material to be released. The incumbent must be able to learn and understand the concepts of statistical sampling used in daily activComputer skills are required. Must be able to read and understand technical drawings. Effective communication skills, including proper grammar, essential in order to report (both in writing and verbally) data and product impact. Must keep neat, accurate, and complete records of materialevaluations and release activities performed. Tactful human relation’s skills are essential to achieve cooperation between business partners andcustomers.

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 math