Quality Assurance Coordinator

Kelly Services; Fort Washington (Montgomery County); On-site; USD 77,366,000 - 81,378,000; Full time

Job summary

Kelly Services in Lititz, PA seeks a Contract Quality Assurance Coordinator to monitor INV/CAPA processes, support investigations, and provide metrics. This on-site, first-shift position is a one-year contract with a pay rate of $27–$28.40 per hour, based on experience.

The contract QA specialist will monitor investigations, track trends, and assist CAPA reviews while coordinating with partners to ensure timely closures and accurate reporting.

Qualifications

• High School Diploma required; plant QA experience preferred.
• Ability to collaborate with internal/external partners and management.
• Experience with Quality Processes and SOPs, CAPA, and investigations.

Responsibilities

• Monitor INV/CAPA process and assist investigations with due dates and resources.
• Track investigation results and CAPA timelines; support CAPA Review Board.
• Support investigations and CAPA by summarizing findings for QA management.
• Provide status updates and metrics for INV/CAPA activities and timelines.
• Engage with operations to ensure timely INV/CAPA closures.

Skills

INV/CAPA monitoring

Data metrics reporting

Cross-functional collaboration

On-site presence

Education

High School Diploma

Job description

Quality Assurance Coordinator Kelly® Science & Clinical is seeking a for Quality Assurance Coordinator a contractposition at a cutting-edge consumer product in Lititz, PA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career. Pay Rate:$27-$28.40 /hr depending on experience Schedule:M-F First Shift on site Length of assignment: one-year possible extension Bring your own IT device laptop role

The Contract QA Specialist will provide support to business partners by monitoring process/status of investigations and CAPAs for products made at the Lititz site. As the Contract QA Specialist for the Lititz INV/CAPA process, the specialist will be responsible for monitoring data for the investigation results, ensuring timelines are met, updating and monitoring Investigation Track and Trends. This role is responsible for administration, effectiveness and continuous monitoring of the INV and CAPA process along with providing metrics for INVs/CAPAs. Are you interested in joining a diverse team influencing strategy and delivering outstanding results to our customers?

Key Responsibilities:

• Monitor INV/CAPA process and assist in monitoring site investigations and ensure appropriate resources are assigned and responsibilities are clearly outlined with due dates. 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 datSupport 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 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 need, developing a trusting environment. Additionally, Interact with various management levels and other business partners responsible for investigations and CAPAs to facilitate timely INV/CAPA closures.

Education:

• High School Diploma

Experience:

• 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

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