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Quality Assurance Equipment Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Equipment Specialist to join our team at Actalent. As a Quality Assurance Equipment Specialist, you will play a critical role in ensuring the quality and reliability of our equipment and systems.
Key Responsibilities- Equipment Maintenance and Troubleshooting: Support the team in investigating and resolving issues related to equipment failures, system deficiencies, and deviations.
- Quality Systems and Records: Author and maintain quality systems records, including deviations, change controls, and CAPAs, as required.
- Project Management and Communication: Monitor and communicate method lifecycle timelines using project management tools.
- Inventory Management: Order supplies and maintain inventory for equipment consumables and accessories.
- Equipment Calibration and Qualification: Coordinate and schedule calibration and qualification activities with Facilities, Metrology, and QC teams.
- Training and Support: Train QC analysts on equipment operation and serve as the point person for equipment inquiries.
- Equipment Repair and Maintenance: Perform non-invasive repairs on UHPLC systems and perform basic troubleshooting.
- Quality Assurance and Control: Review preventative maintenance reports, calibration certifications, and CMMS records, and perform system inventory audits.
- Asset Management: Submit asset induction, work, and administrative requests to ensure equipment failure is addressed promptly.
- Collaboration and Communication: Attend cross-functional meetings and collaborate effectively with QC, QA, Validation, Digital, and Vendors teams.
- Education and Experience: Bachelor's degree in sciences and at least 5 years of industry experience in a cGMP laboratory setting.
- Technical Skills: Familiarity with analytical equipment troubleshooting and maintenance, GMP/GDP/QC data review, and CMMS systems.
- Communication and Collaboration: Strong communication and collaboration skills, with the ability to work effectively in a dynamic, cross-functional matrix environment.
- Equipment Knowledge: Experience with CTU (Controlled Temperature Units) and equipment calibration.
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.
We are committed to diversity, equity, and inclusion, and we strive to create a culture of care, engagement, and recognition that promotes growth opportunities for our people.
