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

GRIFOLS, S.A.•NC-Clayton, CA

5d•Onsite

About The Position

The Quality Operations (QO) Assistant/Associate Materials Evaluation Coordinator evaluates critical visual, dimensional, and functional quality attributes; 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 ensures documentation is complete and accurate, helping protect the safety and efficacy of products. The role performs the final detailed review of materials before release for use, requiring sound judgment, and inspects product final-container reserve samples according to approved procedures. The coordinator may also serve as a Quality representative in the Packaging area, performing sampling, auditing, and Quality decisions. Responsibilities there 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 have significant compliance and monetary implications. The role requires prior inspection experience and the ability to assess deviations, understand statistical sampling, use computers, read technical drawings, communicate findings effectively, and maintain accurate records. Work may take place in an office, laboratory, and/or warehouse, with possible exposure to biological materials and infectious organisms, as well as electrical office and laboratory equipment. The position is scheduled for the second shift, 3:30 p.m. to 2:00 a.m.

Requirements

Associate 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 activities.
Computer skills and ability to read and understand technical drawings.
Effective written and verbal communication skills, including proper grammar, to report data and product impact.
Ability to maintain neat, accurate, and complete records of material evaluations and release activities.
Tactful interpersonal skills to achieve cooperation among business partners and customers.
Extensive knowledge of cGMP, company specifications, and distribution operating procedures.
Ability to wear required safety equipment when working with raw material chemicals, including protective eyewear, garments, and gloves, and to work with limited supervision.
Initiative and ability to 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; excellent color and depth discrimination.
Ability to successfully pass certification requirements for product final-container visual inspection.
Ability to lift up to 50 pounds and meet the stated physical demands of the role.

Nice To Haves

Experience as a QO Assistant Materials Evaluation Coordinator.

Responsibilities

Evaluate critical 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 recognizing potential issues not explicitly addressed by specifications or written requirements.
Issue and track Incidents/Raw Material Reports for discrepant material and quarantine product according to approved disposition procedures.
Stay current with 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 products and materials, 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.
When assigned to Packaging, perform Quality sampling, auditing, and decision-making; audit final product batches using designated ANSI sampling plans.
Perform Packaging responsibilities including reserve sampling, post-pack identity sampling, packaging commodity verification and reconciliation, line-clearance verification, and stability sample inspection.
As an Associate, train new employees in all aspects of the position and serve as a Subject Matter Expert.
Perform other duties as assigned.