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 as QuidelOrtho, we are seeking a Quality Analyst I to work in our Quality Reference Laboratory. The Quality Analyst I in the Fluids Release Laboratory executes complex analytical testing of VITROS Calibrator, Control and other product fluids to support the formulation, release process, stability testing and accuracy of the VITROS products. This testing uses a variety of instrumentation including, but not limited to, VITROS 5,1 and 4600 Chemistry System, pH meter, Chloriometer and manual spectrophotometers. The Quality Analyst I will maintain VITROS instrumentation, calibrates, runs quality control and analyzes requested samples.

In addition, the Quality Analyst I works under the guidance of senior laboratory staff and management to resolve routine to complex analytical quality issues, assist in laboratory investigations and assures the product performance meets specification and claims. Position requires creating test reports, analysis of technical data, evaluation of quality control, and instrument troubleshooting.  Work is scheduled, supervised, and follows established methods and procedures. Business decisions and product performance assessments are dependent upon the procedural attention to detail and technical ability of this individual.

This position is in Rochester, NY. This position will be working on B-Shift but may require over-time and occasional A or C shifts based on production needs and schedule.

The Responsibilities

• Assures compliance to inspection readiness programs within the organization.
• Responsible for providing analytical test results for product performance against specifications to make release decisions for the VITROS fluids.
• This individual will be responsible adhere to quality, GLP, GMP and regulatory compliance policies.
• Works independently to complete product release tests by performing testing on VITROS analyzers and other analytical equipment such as pH meter, viscometer, Conductivity meter, UV-VIS spectrophotometry, Chloridometer, and CO2 Meter in compliance with procedures.
• Maintain equipment, reagents, and supplies. Will require limited work in a freezer.
• Completes analysis of data using spreadsheets or LIMS to report testing results. Reviews data for accuracy and completeness.
• Partners across Fluids Manufacturing to investigate and respond to specification failures or in response to observed trends.
• Completes Laboratory Investigations, Non Conformance Records, or Quality Investigations in a timely manner.
• Careful attention to detail and accuracy of work is essential.
• An understanding of cGMPs and documentation in a regulated industry and experience in documentation protocols and procedures is a plus.
• Planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions
• Perform raw material, intermediates and final product testing
• Calibrate, troubleshoot and maintain laboratory instrumentation and equipment
• Good written and verbal skills are required to draft and review standard operating procedures
• Participate in laboratory investigations, validations and verifications
• Provide analytical and manual dexterity to deliver accurate and precise results from complex analytical methods.
• Mathematically inclined to work up chemical calculations for reagent preparation.
• May require over-time and occasional A or C shifts based on production needs and schedule.

The Individual

• 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) is preferred.
• Problem-solving skills and attention to detail are required.
• Ability to work independently and as part of a team.
• Required Travel: 0-5%

The Key Working Relationships

Internal Partners:

• Production support and cross functional partners

External Partners:

• Outside vendors

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

Physical Demands

Up to 75% in the lab, on manufacturing floor, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role; 25% of time in meetings or on the phone. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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 $23/hour to $25/hour. 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 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 [email protected].