Quality Analyst II, Release Lab

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 6000 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 Quality Analyst II in the Fluids Release Laboratory to execute complex analytical testing of VITROS Calibrators 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 51 Chemistry System pH meter Chloride meter conductivity meter and manual spectrophotometers. The Quality Analyst II will maintain VITROS instrumentation calibrates runs quality control and analyzes requested samples.

In addition the Quality Analyst II works under the guidance of senior laboratory staff and management to resolve routine to complex analytical quality issues Leads laboratory investigations and assures the product performance meets specification and claims. Position requires creating test reports analysis of technical data evaluation of quality control instrument troubleshooting lead inventory participate on production meetings complete document updates in change control system (windchill) draft scheduled and support to lead small validations/projects . 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.

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.

• Organizes/schedule and assures completion of Fluids Release Laboratory testing within established standard operating procedures (update procedures in change control system as appropriate) and will frequently assists team members to accomplish product release tests to meet production timelines.

• Participates and/or assists in Fluids Laboratory investigations may partner with Product Support to resolve issues and completes test results in a timely manner.

• The individual may also contribute to the documentation of any quality records resulting from investigations or product releases and support small validations/projects.

• Completes analysis of data using spreadsheets or LIMS to report testing results. Completes crossover testing for some internal controls and analysis for completion of reports. Reviews data for accuracy and completeness and serves to provide the peer review/second party review of other staff members data.

• Maintains equipment reagents and supplies required for testing VITROS and Products. May require over-time and occasional C or B shifts based on production needs and schedule.

• Performs additional work related duties as assigned.

The Individual

Required:

• Bachelors degree in scientific or related field; Chemistry Biology Microbiology Biochemistry.

• 2 to 4 years of laboratory experience.

• Problem-solving skills and attention to detail are required.

• Ability to work independently and as part of a team.

Preferred:

• Experience in a highly regulated manufacturing environment (Diagnostics Medical Device Pharmaceutical or Consumer) is preferred.

The Key Working Relationships:

Internal Customers: Management Production Engineers Maintenance Operators Quality Analysts/Scientists and Quality Engineers Products and logistics team Product Support Team

External Customers: Outside Vendors and Instrument Service Personnel

The Work Environment:

The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids tissues and samples. Position requires ability to lift to 20 lbs. on a regular basis. Walking standing and sitting for long periods of time (up to 75% of the day) 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. Personal protective equipment is required 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 its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. The salary range for this position is $53000 to $72000 annually and is bonus eligible.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 r