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 Opportunity

As the company continues to grow we are seeking a Quality Technician II for Device History Record (DHR) review and Incoming Inspection. This position is located in Rochester, NY, supporting the Slide Manufacturing site. This part-time position will be 20 hours per week (2 x 8-hour shifts; 1 x 4-hour shift) from 07:00am -03:30pm or 08:00am - 04:30pm (A shift - 8 hours). The potential scheduled workdays are Sunday - Tuesday or Thursday - Saturday.

The Responsibilities

Reviews raw material Certificates of Analysis and Certificates of Conformance for acceptance.
Inspects raw materials for compliance against specifications.
Reviews Device History Records (DHRs) and Incoming Inspection documentation for accuracy, completeness, and compliance per applicable departmental procedures.
Responsible for maintaining Incoming Inspection and DHR records and documentation filing, storage, and logging for shipment to storage facility.
Ability to learn and execute Change Control to document and implement revisions of documents associated with the role.
Ability to observe and participate in cross-functional discussions, meetings, and product reviews to learn and support nonconformances and corrective actions.
Maintains a record of Incoming Inspections and DHR metrics to be presented at quality forums.
Generates nonconformances respective to work area when required and accountable to escalate quality concerns or issues to management.
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.
Perform other work-related duties as assigned.

The Individual

Minimum of BA/BS degree, or 2 years experience, is required.
Knowledge and application using Microsoft Office (Excel, Word, Outlook, Teams, Powerpoint)
Must be detail oriented, having the ability to work both independently and as part of a dynamic team.
Ability to communicate effectively at all levels across the business; effective verbal and written communication
Must work well in an environment with defined production deadlines and changing business needs
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 good documentation practices in a regulated industry.
This position is not currently eligible for visa sponsorship.

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 $21/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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