Quality Analyst 1

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.

QuidelOrtho is searching for a Quality Analyst I. Working in a laboratory environment supporting the manufacturing operations, this person will be responsible for executing release testing and data analysis for release of product.   Individuals will run, maintain, and troubleshoot Vitros 350, 4600, and 3400 analyzers.  This position 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, Non-Conformance & CAPAs (Windchill). 

This position is located in our Operational Quality Laboratories in Rochester, NY.

• Organizes and Executes Vitros product testing under minimal supervision within established timelines and procedures.

• Analyzes and reviews data for accuracy, trends, precision, investigation reports per documented specifications.

• Maintains, troubleshoots, and calibrates equipment/instruments/analyzers.

• Edits/Redlines SOP's/WKI for accuracy

• Participate in laboratory housekeeping, inventory management and other shared duties.

• Maintains a clean and orderly work area in the lab and office.

• Use 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.

• Participate in Overtime as required by the organization.

• Participates in meeting discussions and problem resolutions.

• Perform other work-related duties as assigned.

Required:

• BA/BS degree or equivalent.

• Previous laboratory or similar experience.

• Candidate must learn to run, maintain, and troubleshoot VITROS 350, FS 5, 1, and 4600 analyzers.

• Careful attention to detail and accuracy of work.

• As an FDA regulated facility, documentation is key to this position in order to meet regulatory requirements; therefore, candidate must have an understanding of cGMPs and good documentation practices in a regulated industry.

• Candidate must have a demonstrated proven track record of planning and organization of daily workload, high affinity toward teamwork, and demonstrated problem solving using innovative solutions.

• Full understanding of quality control is expected.

• This position requires an individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting.

• This position requires working in a lab setting which includes standing for long periods of time and wearing personal protective equipment (PPE).

• Candidates are required to work in a BL2 Lab (biohazard level 2) and handle human-derived samples.

Preferred:

• A degree with a science concentration.

• Experience in OCD LIMS or SAP.

• Experience in documentation protocols and procedures.

• Having a working knowledge of computers and windows software.

Internal Partners: Laboratory and office peers, quality team, product support, materials management, slide inspection, slide assembly, and packaging operations

The work environment characteristics are representative of a The work environment is inside a room-temperature controlled laboratory. Other factors which impact the working environment: Temperature: extreme cold (freezer), Biological hazards in lab and Protective equipment required (gloves, eyewear, laboratory jacket).

Continuous standing, frequent sitting. Continuous neck, bending and twisting. Repetitive movement of hands. Some lifting, not to exceed 50 lbs

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $43,000 to $58,000 and is bonus eligible.` 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. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected].

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