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 one QuidelOrtho, we are seeking a Quality Analyst I. This Quality Analyst I position is located in our Operational Quality Laboratories in Rochester, NY. 

The Responsibilities

• Gathers and organizes information from various internal sources, reviews input as needed to develop weekly removable medias.

• Accurately and timely generates the removable medias using Laboratory Information Management Systems.

• Performs Quality checks on the Media and the data that it contains.

• Provides the calibration media to respective external vendors for duplication and distribution to customers.

• Publish weekly documentation of the media content on the company website for customer use.

• Collaboration and communication with business partners for new product launches, product updates, and schedule changes.

• Maintain Quality documentation.

• Support Media Team process improvement initiatives.

• Manages Product data in the Laboratory Information Management System on when it will be released to the removable media.

• Manages the final Device History Record for each media build, confirms all documentation is present, and files the DHR in the record retention storage area.

The Individual

Required:

• Minimum Associate’s degree in scientific or related field. 

• Equivalent combination of education and experience may be considered.

• Problem-solving skills and attention to detail.

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

• Ability to multi-task.

• Strong written and verbal communication skills.

• Ability to work overtime and occasional weekends or alternate shifts as needed.

• Microsoft Excel and Word proficiency.

Preferred:

• 2 years or more of work experience in Biology, Microbiology, Quality, Regulatory, Compliance, or a related field.

• Understanding of Windows based applications and lab management systems.

• Must adhere to quality, GLP, GMP and regulatory compliance policies.

• Flexible in scheduling to ensure deadlines are met.

• May require over-time and occasional B shift based on production needs and schedule.

• Must follow GLP and GMP practices.

The Key Working Relationships

Internal Partners: Quality, Product Support, PP&L/Materials Management, Operations

External: Suppliers

The Work Environment

• Manufacturing, laboratory, or warehouse setting.

• Exposure to viral and bacterial hazards, hazardous chemicals, and potentially infectious materials.

• Flexible work hours to meet project deadlines.

The Physical Demands

• Light

• Sitting, standing, walking. 

• Computer

​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. 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].

#LI-SP1