Quality Analyst 1 - Microbiology

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 support our microbiology lab. This person will support the outgoing quality of the Calibrators, Controls and reagents by executing microbiological test procedures to confirm product performance meets specifications and claims. Also perform environmental monitoring testing, participate in Biocontrol GEMBA of the manufacturing control/critical areas and complete incident reports when applicable. The individual will also complete laboratory investigations for quality control issues as they arise and when appropriate initiate Non conformances.

The position also maintains supplies/inventory/orders, ATCC library for QC of media, maintenance of equipment/ control and critical laboratory rooms. This individual will organize the logistics of the testing using the tools available for testing and transfers.

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 (3pm -11pm) but may require over-time and occasional A or C shifts based on production needs and schedule.

The Responsibilities

• Planning and organization of daily workload. Works independently using specific technique to complete microbiological product release tests by performing testing on products, raw materials, water and environmental monitoring. Prepares product samples for multiple groups testing needs aseptically.
• Maintain equipment, reagents, room and supplies on the appropriate frequency.
• Assures compliance to inspection readiness programs within the organization and this individual will be responsible adhere to all quality, GLP, GMP and regulatory compliance policies. Completes Laboratory Investigations, Non Conformance Records, or Quality Investigations in a timely manner.
• Completes analysis of data using spreadsheets (Tracking and Trending) or LIMS to report testing results. Reviews data for accuracy and completeness.
• Assures compliance to inspection readiness programs within the organization.
• Partners across Fluids 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.
• Asist with validation/qualification of test methods, processes and equipment.
• Performs necessary housekeeping to ensure the laboratory is continuously maintained in safe, orderly and compliant condition.
• May require over-time and occasional C or B shifts based on production needs and schedule.
• Perform other work-related duties as assigned.

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:

• Internal customers include other release laboratories (Control Value Assignment group, Research and Development, Product Support, Customer Complaints and Customer Technical Services, Operations B642 and B313, Planning and logistics group).

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. Works in PPE and Bloodborne pathogen training required, limited work in freezer/refrigerator, and must adhere to quality, GLP, GMP and regulatory compliance policies. Required to gown up for critical rooms and controls rooms.

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. Some lifting is required, not to exceed 50 pounds.

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 recruiting@quidelortho.com.