Quality Analyst I

2 weeks ago

Rochester, United States QuidelOrtho Full time
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 the company continues to grow, we are seeking a SPQC Quality Analyst I. This SPQC Quality Analyst I position is located in our Operational Quality Laboratories in Rochester, NY.

Work Schedule: B shift (2:00pm -10:30pm), Sunday through Thursday.

The Responsibilities

  • Executing release testing and data analysis for release of product.

  • Individual will run, maintain, and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.

  • Work in partnership with manufacturing Operations, Product Support and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product.

  • The individual will execute Vitros testing following Test Designs and analyze data for the release of product.

  • Routinely interacts with data management systems such as LIMS, SAP, Document Management Systems (OTIS), and Non-Conformance & CAPAs (QERTS).

The Individual

  • BA/BS degree or equivalent is required; A degree with a science concentration is preferred.

  • Previous laboratory or similar experience is required.

  • Candidate must be willing to learn to run, maintain and troubleshoot Vitros 350, FS 5, 1, and 4600 analyzers.

  • Candidate must have analytical knowledge required for production releases.

  • Experience in OCD LIMS or SAP is preferred.

  • 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.

  • 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.

  • Having a working knowledge of computers and windows software is desired.

  • 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.

  • This position requires working in a lab setting which includes standing for long periods of time and wearing personal protective equipment (PPE).

  • Candidates are required to work in a BL2 Lab and handle human samples.

The Key Working Relationships

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

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

  • Some lifting up to 50 pounds

  • Manual dexterity for handling instruments and repetitive motion

  • Standing for extended periods

  • 75% in the lab, requiring walking, standing, and sitting for long periods

  • 25% in meetings or on the phone

  • Wearing appropriate PPE in the lab

  • Close and distance vision, ability to adjust focus

  • Ability to operate lab equipment

  • Adherence to personal protective equipment guidelines

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.

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