Quality Operations (QO) Assistant / Associate Materials Evaluation Coordinator

Quality Operations (QO) Assistant / Associate Materials Evaluation Coordinator

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: Quality

Position Summary: The Quality Operations (QO) Assistant/Associate Materials Evaluation Coordinator evaluates critical quality attributes (visual, dimensional, functional), coordinates 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 container components, process hoses, sterilizing filters, and other critical raw materials. This is done by verifying compliance to specifications and testing requirements and ensuring required documentation is complete and accurate thus minimizing the possibility that the safety and efficacy of final products manufactured and tested using these quality managed materials is compromised or adulterated. The Coordinators perform the last detailed review of these materials prior to release for use thus sound judgment is essential. The QO Assistant/Associate Materials Evaluation Coordinator inspects 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, and making Quality decisions. In this area, the QO Assistant/Associate Materials Evaluation Coordinator audits final product batches using designated ANSI sampling plans. Additionally, the Packaging QO Coordinator responsibilities include: reserve sampling, post-pack identity sampling, packaging commodity 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 approved usage decisions on all quality managed material used at the facility.
• Determine the acceptability of materials (i.e. labels, chemicals, raw material components, etc.) that can at times require recognition of problems or potential use issues not always addressed by specifications or other written requirements.
• Issue and track Incidents/Raw Material Reports (RMRs) for discrepant material and quarantine product per approved procedures that govern disposition of such discrepant material.
• 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.
• Conduct a physical inspection of products as well as fully review all documentation and labeling to insure that outgoing shipments are compliant with specifications, product licenses, CFR, and customer specific requirements.
• Responsible for reconciliation of all product released (i.e.. Labels, plasma, raw material components, etc.) Non-reconciliation of material could be means for material or plasma product recall and will impact product market availability.
• Prepare/review/and revise documentation related to labeling specifications, raw material criteria, outgoing shipment specifications, etc.
• 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 are considered to be a Subject Matter Expert (SME).
• And other duties as assigned.

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 material 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 QO Assistant Materials Evaluation, is required for the QO Associate Materials Evaluation position. Incumbent must have prior inspection experience (i.e. manufacturing components, packaged goods, etc.)

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an 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, garments and gloves and able to work with limited supervision. Must demonstrate initiative and have the ability to defend a decision based on specifications and procedures. 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 blindness, excellent color and depth discrimination, and be able to lift up to 50 lbs. The incumbent must be able to successfully pass the certification requirement for product final container visual inspection. Work is performed in an office, laboratory and/or warehouse environment. Possibility of exposure to biological material with potential exposure to infectious organisms exists. Exposure to electrical office and laboratory equipment. Work is performed sitting, walking or standing for 7-8 hours per day. Repetitive movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 50 lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Repetitive foot movements.