Quality Assurance Specialist

2 days ago

Ellenville, New York, United States Quidel Corporation Full time
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 a global organization with a presence in over 130 countries, providing fast, accurate, and consistent testing where and when it's needed most - from home to hospital, lab to clinic.

Our culture prioritizes the well-being and success of our team members, fostering a work environment that supports happiness, inspiration, and engagement. We strive to build meaningful connections with each other, recognizing 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

We're 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.

As a Quality Lab Analyst, you will execute complex analytical tests and perform data analysis of VITROS products (Chemistry Calibrators, Controls, Reagents, and other support fluids) using Excel spreadsheets and various instrumentation (VITROS 3600, 5600, and Eci Chemistry Systems).

You will maintain VITROS instrumentation, perform maintenance, calibrations, and quality control.

Under the guidance of senior laboratory staff, you will resolve routine quality issues, assist in laboratory investigations, and ensure product performance meets specifications and claims.

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

This is a full-time onsite position at our Rochester, NY location.

Responsibilities
  1. Complete release and in-process tests supporting Vitros products by executing analytical testing on multiple types of equipment in compliance with all procedures.
  2. Provide analytical and manual dexterity to deliver accurate and precise results.
  3. Perform reagent, calibrator, performance verifier, fluid intermediates, and final product testing.
  4. Organize and ensure completion of Release Laboratory testing within established standard operating procedures.
  5. Assist team members to accomplish product release tests to meet production timelines.
  6. Complete basic analysis of data using validated spreadsheets.
  7. Perform crossover testing for internal controls and other release fluids.
  8. Review basic data for accuracy and completeness and serve as a peer reviewer for other QA1 members' data.
  9. Assist in Release Laboratory investigations.
  10. Contribute to the running of the test and support of data analysis with senior lab staff.
  11. Perform equipment maintenance and maintain lab supplies required for testing VITROS products.
  12. Perform necessary housekeeping to ensure the laboratory is continuously maintained in a safe, orderly, and compliant condition.
Requirements
  • Minimum 2-year degree in a scientific or related field.
  • 0-2 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 detail.
  • 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.
Key Working Relationships

Internal:

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

External:

  • Outside vendors and instrument service personnel
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 long 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.

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