Job 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
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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Equal employment opportunities for all employees. We fulfills this commitment through a variety of measures including internal & external posting of job openings, hiring, training & promoting individuals without regard to race, color, religion, sex, pregnancy, national origin, ancestry, citizenship, veteran status, disability, medical condition, marital or domestic partner status, sexual orientation, gender identity, age,or any other considerations made unlawful by federal,state or local law
