Quality Analyst I

4 weeks ago

Rochester, New York, United States QuidelOrtho 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 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, as one QuidelOrtho we are seeking a Quality Analyst I in Microbiology to ensure the outgoing quality of our Calibrators, Controls and reagents by executing microbiological test procedures to confirm product performance meets specifications and claims. This position is located in Rochester, NY.

The Responsibilities
  • Perform environmental monitoring testing, participate in Biocontrol GEMBA of the manufacturing control/critical areas and complete incident reports when applicable.
  • Complete laboratory investigations for quality control issues as they arise and, when appropriate, initiate Non conformances.
  • Maintain supplies/inventory/orders, ATCC library for QC of media, maintenance of equipment/ control and critical laboratory rooms. Maintain equipment, reagents, room and supplies on the appropriate frequency.
  • Organize the logistics of the testing using the tools available for testing and transfers.
  • Work independently using aseptic technique to complete microbiological product release tests by performing testing on products, raw materials, water and environmental monitoring. Prepare product samples for multiple groups testing needs aseptically.
  • Ensuring compliance to inspection readiness programs within the organization, will be responsible to adhere to all quality, GLP, GMP and regulatory compliance policies. Complete Laboratory Investigations, non-conformance Records, or Quality Investigations in a timely manner.
  • Complete analysis of data using spreadsheets (Tracking and Trending) or LIMS to report testing results. Review data for accuracy and completeness.
  • Partner across Fluids/Microwell Manufacturing/Rochester Reagent Manufacturing to investigate and respond to specification failures or in response to observed trends.
  • Provide analytical and manual dexterity to deliver accurate and reproducible results from complex microbiological methods.
  • Assist with validation/qualification of test methods, processes and equipment.
  • Performs additional work related duties as assigned.
The Individual

Required:

  • Associate's Degree in Microbiology, Biology, Medical Technology, Biochemistry.
  • 2 years of laboratory experience or equivalent combination of education and experience.
  • Strong problem-solving skills
  • Strong attention to detail.
  • Ability to work independently and as part of a team
  • Ability to work over-time and occasional weekends, or alternate shifts as needed.

Preferred:

  • Bachelor's degree in Microbiology, Biology, Medical Technology, Biochemistry.
  • Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer.)
The Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk, analyzing data, in meetings as well as hand-on product testing as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

The Key Working Relationships

Internal partners: Operations, Quality, and R&D teams

External partners: Distributers

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 to $81,000.00 and is eligible a bonus. 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 the 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

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