QC Technician II

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

The Quality Control Technician II is primarily responsible for performing Quality Control testing products at various stages of Production, as well as occasional basic technical tasks such as document control, maintenance of work areas and may perform inventory control. The QC Technician II will be expected to maintain proficiency in all areas such that re-assignment will be seamless when there are changes to workload and/or company focus. This role is located in Athens, Ohio.

The Responsibilities

• Performs and documents QC testing of WIP production lots and special evaluation assignments.

• Performs Data Processing (QDAT/DECA)

• Performs daily QC Chemistry core functions as needed.

• Writes document redlines

• Performs and documents final QC testing

• Performs complaint resolution

• Supports daily QC Chemistry core functions as needed

• Performs and documents 1st article functional Sofia Final Kit QC testing

• Supports new product development/improvement projects

• Conducts general housekeeping and laboratory organization

• Carries out duties in compliance with established business policies

• Performs routine checks

• Operates laboratory equipment safely, as trained and directed, in accordance with established practices.

• Trains, mentors, and guides QC Tech I, as needed.

The Individual

Required:

• Bachelor's degree in Chemistry, Biology, Life Science or similar discipline or equivalent experience

• 1-3 years in Quality Control or manufacturing laboratory environment

• Experience working with a microscope

• Basic data analysis and report writing skills

• Knowledge of aseptic technique

• Ability to read, interpret and follow detailed procedures, instructions and drawings

• Solid understanding of QSRs/ISO

• Chemistry and laboratory skills, GLP/GMP experience

• Demonstrated team-oriented interaction skills/professional behavior

• Strong written and verbal communication skills

• Computer skills, including word processing, spreadsheet creation and manipulation, report generation, email, etc.

• Must know quality terms, definitions and concepts

• Must understand traceability (product, material, and calibration)

• Ability to discern product and process integrity to defined standards and methods, with the initiative to take appropriate action.

Preferred:

• Experience in a medical device, high-volume manufacturing environment

• Knowledge of quality systems and regulations for medical device industry

• Working knowledge of QC systems and non-conforming material handling requirements

The Key Working Relationships

Internal Partners:

Management team, Supplier Quality Engineers, Production, Quality Assurance

External Partners:

Suppliers

The Work Environment

The work environment characteristics are representative of an office, laboratory, and manufacturing environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, 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 20 lbs. on a regular basis. Up to 90% of time at lab bench or desk, walking, standing, and sitting for long 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. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

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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