Quality Analyst I

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.

• 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.

Required:

• 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.

Preferred:

• Degree with a science concentration.

• Experience in QO LIMS or SAP.

• Experience in documentation protocols and procedures.

Internal: Quality, Product Support, PP&L/Materials Management, Operations (MCI, SAM ,Packaging)

External: Vendors and contractors

The work environment characteristics are representative of an office, laboratory and manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. Position requires ability to lift up to 50 lbs., work within restricted areas confined by equipment. Up to 50% of time/work within a low humidity environment with potential exposure to biological, toxic and corrosive reagents; and up to 50% is required to work within the confinements of a cubical style office, and also within a laboratory setting. Walking, standing and sitting for longs periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must be willing to work 1st or 2nd shift. Position requires use of Personal Protective Equipment as posted.

Essential functions are subject to change as other duties may be assigned.

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 $48,000 to $58,000 annually 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].