Quality Analyst I - Rochester, United States - QuidelOrtho

QuidelOrtho Rochester, United States

4 weeks ago

Full time

Description

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. This position in the CVA MicroTip laboratory is responsible for creation of test designs, execution of all uTIP Implementation, Gen Disposition/Gen Assignment, New Generation, Performance Verifiers, Thermo MAS controls, and Calibrator Kit Crossover testing. 1st review of data analysis will be performed to support this testing in the release of Masterlots, new Gens, target values and calibrator SAV's. In addition, responsibilities include but not limited to, maintaining the master test schedule, reagent/fluid inventory management and maintaining daily, weekly, and monthly maintenance on the Virtros analyzers.

This is an onsite position 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, investigation reports, and performs value assignment per documented specifications.
Maintains, troubleshoots, and calibrates equipment/instruments/analyzers
Writes, maintains and updates SOPs.
Assists with laboratory housekeeping, inventory and other shared lab duties

The Individual

Required:

A BA/BS degree or equivalent.
Previous laboratory or similar experience.
Candidate must be willing to learn to run, maintain and troubleshoot Vitros 350, XT3400, FS 5, 1, and 4600 analyzers.
Candidate must have analytical knowledge required for production releases.
Careful attention to detail and accuracy of work.
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.
Experience in documentation protocols and procedures are a plus.
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.
Full understanding of quality control is expected.
This position requires an individual who can multi-task, adapt to changes in daily workload and priorities, and function in a cross-functional team setting.

Preferred:

Degree with a science concentration.
Experience in Ortho LIMS or SAP.
Having a working knowledge of computers and windows software.

The Key Working Relationships

Internal: Quality, Product support, PP&L/Materials Management, Operations.

External: Outside Vendors and Suppliers

The Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 50 lbs., work within restricted areas confined by equipment. Up to 50% of time/work within a low humidity environment and/or extreme cold environment with potential exposure to biological, toxic and corrosive reagents; and up to 50% is required to work within the confinements of a cubical style office, and also within a laboratory setting. Walking, standing and sitting for longs periods of time 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. Position requires use of Personal Protective Equipment as posted. Essential functions are subject to change as other duties may be assigned.

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. A salary range for this position is $43,000 - $73,000. 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 their 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

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