Quality Analyst I
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. As we continue to grow as one QuidelOrtho, we are seeking a Quality Analyst I. The Quality Analyst I will be working in a laboratory environment supporting the manufacturing operation. This person will be responsible for executing release testing and data analysis for release of product. This individual will run, maintain, and troubleshoot Vitros 350, FS 5,1, 4600, and 3400XT analyzers. The Quality Analyst I works in partnership with manufacturing Operations, Product Support, and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product. The individual will execute Vitros testing following Test Designs and analyze data for the release of product. Routinely interacts with data management systems such as LIMS, SAP, Document Management Systems (Windchill), and Non-Conformance & CAPAs (QERTS). This position is in Rochester NY. SCHEDULE: Monday - Friday. Requires flexibility A shift (7:00am-3:30pm) depending on business needs.
Requirements
- A BA/BS degree or equivalent.
- Previous laboratory or similar experience.
- Candidate must be willing to learn to operate, maintain and troubleshoot Vitros 350, FS 5,1, 3400, and 4600 analyzers.
- Candidate must have analytical knowledge required for production releases.
- Careful attention to detail and accuracy of work.
- Must have an understanding of cGMPs and documentation in a regulated industry.
- Candidate must have a proven track record of planning and organization of daily workload.
- High affinity toward teamwork and demonstrated problem solving using innovative solutions.
Nice To Haves
- Degree with a science concentration.
- Experience in QO LIMS or SAP.
- Experience in documentation protocols and procedures.
Responsibilities
- Organizes and Executes Vitros product testing under minimal supervision within established timelines and procedures.
- Analyzes data for accuracy, trends, precision, investigation reports per documented specifications.
- Maintain, troubleshoots and calibrates equipment/instruments/analyzers.
- Edits/Redlines SOP's/WKI for accuracy
- Participates in laboratory housekeeping, inventory management and other shared duties.
- Maintains a clean and orderly work area in lab and office.
- Uses Quality Systems for document retrieval and on-line learning.
- Some lifting not to exceed 50lbs. Manual dexterity of handling instruments and repetitive motion. Standing for long periods of time.
- Identifies unacceptable product quality and takes appropriate actions.
- Wears appropriate PPE in the lab.
- Participates in Overtime as required by the organization.
- Participates in meeting discussions and problem resolutions.
- Perform other work-related duties as assigned.
Benefits
- QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
