Operations Coordinator Jobs

About The Position

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.