Quality Assurance Coordinator

About the role

Kelly® Science & Clinical is seeking a Quality Assurance Coordinator for a contract position at a cutting-edge consumer product in Lititz, PA. Trust The Experts at Hiring Experts to bring you this exciting opportunity.

Responsibilities

• Maintain the INV/CAPA process and assist in monitoring site investigations.
• Provide Metrics for INVs/CAPAs.
• Track and Trend investigations and CAPA as required.
• Support CAPA Review Board and lead as required.
• Support investigation and CAPA partners by monitoring due dates.
• Provide detailed or summary communication to QA management on status of key initiatives and issues related to investigation and CAPA due dates.
• Perform and understand investigation trending in order to determine appropriate INV or CAPA trend responses, and ensure metrics are readily available for reporting.
• Use metrics to ensure all investigations are drafted to meet specified timelines and are completed prior to the release of associated product(s).
• Establish relationships with Operation’s business partners by understanding their needs, developing a trusting environment.
• Interact with various management levels and other business partners responsible for investigations and CAPAs to facilitate timely INV/CAPA closures.

Qualifications

• High School Diploma.
• Basic knowledge (Plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production Knowledge.
• Skills and Abilities: Ability to collaborate with internal/external partners to enhance relationships and interactions, including interaction with management to inform, inspire change, and provide direct feedback. Proven track record to accomplish work goals, with a modest amount of daily direction and oversight. Ability to be on site daily. Quality Process and Systems Experience, especially with SOPs, MWI, Change Controls, Non-Conformance Investigation Documentation. Problem Solving.