Quality Assurance Coordinator

About the role

Kelly® Science & Clinical is seeking a contract Quality Assurance Coordinator for a cutting-edge consumer product in Lititz, PA.

Pay

$27–$28.40 per hour depending on experience

Schedule

Monday–Friday, first shift, on-site

Length of assignment

One-year contract with possible extension

Responsibilities

• Monitor the INV/CAPA process and assist in monitoring site investigations to ensure appropriate resources are assigned and responsibilities are clearly outlined with due dates.
• Provide metrics for INVs/CAPAs and track and trend investigations and CAPAs as required.
• Support the CAPA Review Board and lead as required.
• Support investigation and CAPA partners by monitoring due dates.
• Support customer complaints by investigating complaints and providing summary of findings.
• 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 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 Operations business partners by understanding their needs, developing a trusting environment, and interacting with various management levels to facilitate timely INV/CAPA closures.

Requirements

• High school diploma
• Basic knowledge (plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements production

Qualifications

• 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.

Skills

• Problem solving