Quality Analyst I

Ortho Clinical Diagnostics • Rochester, NY

283d • $23 - $25

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

Requirements

• Minimum Associate's degree in scientific or related field.
• Equivalent combination of education and experience may be considered.
• Problem-solving skills and attention to detail.
• Ability to work independently and as part of a team.
• Ability to multi-task.
• Strong written and verbal communication skills.
• Ability to work overtime and occasional weekends or alternate shifts as needed.
• Microsoft Excel and Word proficiency.

Nice To Haves

• 2 years or more of work experience in Biology, Microbiology, Quality, Regulatory, Compliance, or a related field.
• Understanding of Windows based applications and lab management systems.
• Must adhere to quality, GLP, GMP and regulatory compliance policies.
• Flexible in scheduling to ensure deadlines are met.

Responsibilities

• Gathers and organizes information from various internal sources, reviews input as needed to develop weekly removable medias.
• Accurately and timely generates the removable medias using Laboratory Information Management Systems.
• Performs Quality checks on the Media and the data that it contains.
• Provides the calibration media to respective external vendors for duplication and distribution to customers.
• Publish weekly documentation of the media content on the company website for customer use.
• Collaboration and communication with business partners for new product launches, product updates, and schedule changes.
• Maintain Quality documentation.
• Support Media Team process improvement initiatives.
• Manages Product data in the Laboratory Information Management System on when it will be released to the removable media.
• Manages the final Device History Record for each media build, confirms all documentation is present, and files the DHR in the record retention storage area.

Benefits

• Comprehensive benefits package including medical, dental, vision, life, and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off (including sick time).
• Paid Holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Associate degree