Quality Assistant/Associate Materials Evaluation Coordinator

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 mathematics or an equivalent combination of education and experiencacceptable.

Experience:
A minimum of one year of related experience, preferably as a QC Assistant Materials Evaluation, is required for the QC Associate Materials Evaluation position.
Incumbent must have prior inspection experience (i.e. manufacturing components, etc.).

Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competenciemay be considered in place of the stated requirements. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, equivalent could include 4 years of experience or a Bachelor's degree.

Occupational Demands:
When working with raw material chemicals, the incumbent must be able to wear all required safety equipment such as protective eyewear, garmentsgloves and able to work with limited supervision. Must demonstrate initiative and have the ability to defend a decision based on specifications andprocedures. In addition the incumbent must have near vision correctable to at least 20/20 in one eye and 20/40 in the other eye, have no color blindexcellent color and depth discrimination, and be able to lift up to 50 lbs. The incumbent must be able to successfully pass the certification requiremfor product final container visual inspection.

Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure toinfectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment.Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precisecoordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs.Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Colorperception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words andsentences. Performs tasks by following a set of written or oral instructions/procedures.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]

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