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 Quality Analyst I to support our Operational Quality Laboratories. Analyst I in the Stability lab monitors QO Vitros Clinical Chemistry products (fluids, Microslide, Microtip and supporting fluids) by continuous verification against their stated labeled storage instructions or claims. The analyst is responsible for the creation of test designs and execution of long term, on analyzer and open vial Stability testing. Required products are obtained and stored, and testing is performed on the Vitros Chem system at each test outdate. Data is analyzed and compared to the stability limits. In addition, the analyst will assist Product Support in investigation of limit failures and maintain daily, weekly and monthly maintenance on the Vitros analyzers.
This position will be onsite full-time in Rochester, NY.
The Responsibilities
- Organizes and performs Vitros product testing under minimal supervision within established timelines and procedures.
- Analyzes data for accuracy, trends, precision, and investigation reports.
- Maintains, troubleshoots, and calibrates analyzers.
- Write, maintains and updates SOPs.
- Assists with laboratory housekeeping, inventory and other shared lab duties.
- Maintains a clean and orderly work area.
- Uses computer to access Quality Systems documents and on-line learning.
- Perform other work-related duties as assigned.
The Individual
Required
- BA/BS degree or equivalent experience is preferred; A degree with a science concentration is preferred.
- Previous laboratory or similar experience is required.
- Willing to learn to run, maintain and troubleshoot Vitros 350, XT3400, and 4600 analyzers.
- Analytical knowledge required for production releases.
- Careful attention to detail and accuracy of work are required.
- As an FDA regulated facility, documentation is key to this position in order to meet regulatory requirements; therefore, candidate must have an understanding of cGMPs and documentation in a regulated industry.
- Candidate must have a demonstrated proven track record of planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions.
- Working knowledge of computers and windows software is desired.
- Full understanding of quality control is expected.
- An individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting.
Preferred
- Experience in OCD LIMS or SAP
- Experience in documentation protocols and procedures.
The Key Working Relationships
Internal Partners
- Quality, Product Support, PP&L/Materials Management, Operation
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
The Physical Demands
Some lifting not to exceed50lbs. Manual dexterity of handling instruments and repetitive motion. Standing for long periods of time. Up to 75% 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. Wears appropriate PPE in the lab. 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. 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.