Quality Control Assistant/Associate Materials Evaluation Coordinator

Quality Control Assistant/Associate Materials Evaluation Coordinator

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: Quality

Shift: First, Monday through Friday

Hours: 8:00 am to 4:30 pm

The Quality Control 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 QC Assistant/Associate Materials Evaluation Coordinator inspects product final container reserve samples according to approved standard operating procedures.

The QC Assistant/Associate Materials Evaluation Coordinator may perform in the warehouse as a Quality representative for sampling, auditing, and making Quality decisions. In this area, the QC Assistant/Associate Materials Evaluation Coordinator audits raw material batches using designated ANSI sampling plans.

Decisions made by QC 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.
• 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 QC 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 relations' 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 QC Assistant Materials Evaluation, is required for the QC Associate Materials Evaluation position. Incumbent must have prior inspection experience (i.e. manufacturing components, etc.)

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.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified applicants in a manner consistent with the requirements of applicable state and local laws.