Quality Operations (QO) Associate Materials Evaluation Coordinator - 2nd Shift

Grifols•Clayton, NC

3d•Onsite

About The Position

The Quality Operations (QO) Associate Materials Evaluation Coordinator evaluates critical quality attributes—including visual, dimensional, and functional characteristics—coordinates required chemical and/or biological testing, and executes approved usage decisions for quality-managed materials used at the facility. Materials include chemicals, labeling components, primary drug container components, process hoses, sterilizing filters, and other critical raw materials. The coordinator verifies compliance with specifications and testing requirements and checks that required documentation is complete and accurate, helping protect the safety and efficacy of products. This role performs the final detailed review of materials before release, so sound judgment is essential. The coordinator inspects product final-container reserve samples according to approved procedures and may serve as a Quality representative in the Packaging area, where duties include sampling, auditing, and making Quality decisions. Packaging responsibilities can include auditing final product batches using designated ANSI sampling plans, reserve sampling, post-pack identity sampling, packaging commodity verification and reconciliation, line-clearance verification, and stability sample inspection. Decisions made in this role can have significant compliance and financial implications. The position requires knowledge of cGMP, company specifications, and distribution operating procedures. Associate-level coordinators also serve as subject-matter experts and train new employees in the position. Work may take place in an office, laboratory, and/or warehouse, with possible exposure to biological material and infectious organisms, as well as electrical office and laboratory equipment. The scheduled hours are 2nd shift, 3:30 p.m. to 2:00 a.m.

Requirements

At least an Associate's degree with an emphasis in sciences or mathematics, or an equivalent combination of education and experience.
For the QO Associate Materials Evaluation position, at least one year of related experience is required; experience as a QO Assistant Materials Evaluation is preferred.
Prior inspection experience, such as inspection of manufacturing components or packaged goods.
Keen assessment skills and the ability to distinguish insignificant deviations from significant deviations that could jeopardize material integrity.
Ability to learn and understand statistical sampling concepts used in daily work.
Computer skills.
Ability to read and understand technical drawings.
Effective written and verbal communication, including proper grammar, to report data and product impact.
Ability to keep neat, accurate, and complete records of material evaluations and release activities.
Tactful interpersonal skills to achieve cooperation with business partners and customers.
Ability to wear required safety equipment, including protective eyewear, garments, and gloves, when working with raw material chemicals.
Ability to work with limited supervision, show initiative, and defend decisions based on specifications and procedures.
Near vision correctable to at least 20/20 in one eye and 20/40 in the other eye; no color blindness; and excellent color and depth discrimination.
Ability to lift up to 50 pounds.
Ability to successfully pass the certification requirement for product final-container visual inspection.

Nice To Haves

Related experience as a QO Assistant Materials Evaluation Coordinator.

Responsibilities

Evaluate visual, dimensional, and functional quality attributes of quality-managed materials; coordinate required chemical and/or biological testing; and execute approved usage decisions.
Determine whether materials such as labels, chemicals, and raw material components are acceptable, including identifying potential problems not expressly addressed by specifications or written requirements.
Issue and track Incidents/Raw Material Reports (RMRs) for discrepant material and quarantine product under approved procedures.
Stay informed about changing regulatory agency requirements that affect materials evaluation and release to production.
Physically inspect products and review documentation and labeling to ensure outgoing shipments comply with specifications, product licenses, CFR, and customer-specific requirements.
Reconcile all released product, including labels, plasma, and raw material components.
Prepare, review, and revise documentation related to labeling specifications, raw material criteria, and outgoing shipment specifications.
Inspect product final-container reserve samples according to approved standard operating procedures.
As a Quality representative in Packaging, perform sampling and audits and make Quality decisions; audit final product batches using designated ANSI sampling plans.
Perform Packaging activities including reserve sampling, post-pack identity sampling, packaging commodity verification and reconciliation, line-clearance verification, and stability sample inspection.
For Associate-level coordinators, train new employees in all aspects of the position and serve as a subject-matter expert.
Perform other duties as assigned.