Quality Analyst I

The Opportunity

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.

The Role

As we continue to grow, we are seeking a Quality Lab Analyst to work in our MicroWell Release Lab supporting QA for the Microwell product line in our new manufacturing facility in Rochester. Will execute complex analytical tests and perform data analysis of VITROS products (Chemistry Calibrators, Controls, Reagents, and other support fluids) using Excel spread sheets, and a variety of instrumentation (VITROS 3600, 5600 and Eci Chemistry Systems). Will maintain VITROS instrumentation, perform maintenance, calibrations, and performs quality control.

Will work under the guidance of senior laboratory staff to resolve routine quality issues, assist in laboratory investigations, and assures the product performance meets specification and claims.

This position will initially be supporting Microwell product line and may also include performing these job duties in other release laboratories within Building 313 and 642.

This position will be onsite full-time at our Rochester, NY location.

SCHEDULE: Monday - Friday. Typically 7:00-3:30pm or 8:00-4:30pm.

Requires flexibility between A shift and B shift (1:30pm -10:00pm) depending on business need.

The Responsibilities

• Completes release and in process tests supporting Vitros products by executing analytical testing on multiple types of equipment in compliance with all procedures; and provides analytical and manual dexterity to deliver accurate and precise results.
• Perform reagent, calibrator, performance verifier, fluid intermediates and final product testing. Organize and ensure completion of Release Laboratory testing within established standard operating procedures and assist team members to accomplish product release tests to meet production timelines.
• Completes basic analysis of data using validated spreadsheets. Performs crossover testing for internal controls and other release fluids. Reviews basic data for accuracy and completeness and serves to provide the peer review of other QA1 member's data.
• Assists in Release Laboratory investigations. The individual will contribute to the running of the test and support of the data analysis with senior lab staff.
• Performs equipment maintenance and maintains lab supplies required for testing VITROS products.
• Performs necessary housekeeping to ensure the laboratory is continuously maintained in safe, orderly and compliant condition.
• Works in PPE and Bloodborne pathogen training required.
• Flexible in scheduling to ensure deadlines are met.
• Must adhere to quality, GLP, GMP and regulatory compliance policies.
• May require over-time and occasional B or C shifts based on production needs and schedule.
• Perform other work-related duties as assigned.

The Individual

Required:

• Minimum 2 year degree in scientific or related field; equivalent combination of education and experience may be considered.
• 0 to 2 years of work experience in Biology, Microbiology, Quality, Regulatory, or Compliance in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical or Consumer)
• Strong attention to details
• Ability to work independently and as part of a team.
• Ability to work overtime and occasional weekends or alternate shifts as needed.
• 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:

• Bachelor’s degree with a science concentration.

The Key Working Relationships

Internal: Management, Production Engineers, Maintenance Operators, Quality Analysts/Scientists, and Quality Engineers, Products and logistics team, Product Support Team, R&D scientist

External: Outside vendors and instrument service personnel

The Work Environment

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.

Physical Demands

Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required. Including sitting, standing, walking, bending, squatting, balancing (Maintaining body equilibrium to prevent falling when walking, standing or crouching on narrow, slippery or erratically moving surfaces. Amount and kind of balancing exceeds that needed for ordinary locomotion and maintenance of body equilibrium), and ability to lift up to 30lbs.

Salary Transparency

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 $45,000.00 - $50,000.00. 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.

Equal Employment Opportunity

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 recruiting@quidelortho.com.