Quality Associate Materials Evaluation Coordinator

Grifols • Clayton, NC

7d • Onsite

About The Position

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 detail 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 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.

Requirements

• 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.
• 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, 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.).
• Requires minimum of an Associates degree with an emphasis in sciences or mathematics or an equivalent combination of education and experience is acceptable.
• 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 be able to work with limited supervision.
• Must demonstrate initiative and have the ability to defend a decision based on specifications and procedures.
• 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.
• Must be able to successfully pass the certification requirement for product final container visual inspection.
• Frequent hand movement of both hands with the ability to make fast, simple, 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 35lbs.
• Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height.
• Frequent foot movements.
• Color perception/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 and sentences.
• Performs tasks by following a set of written or oral instructions/procedures.

Nice To Haves

• Extensive knowledge of cGMP, company specifications and distribution operating procedures.

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.
• Issue and track Incidents/Raw Material Reports (RMRs) for discrepant material and quarantine product per approved procedures that govern disposition of such discrepant material.
• Stay abreast of the rapidly changing requirements of various regulatory agencies. New policy changes from these groups has a definite immediate 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 could mean for material or plasma product recall and will impact product market availability.
• Serve as trainers to new employees in all aspects of this position and are considered to be a Subject Matter Expert (SME).

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree