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Lead Molecular Biochemist
6 months ago
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
Under minimal supervision, the scope of this position is responsible for a variety of production and non-production functions in support of manufacturing goals, monitoring product quality through testing and observation. Additionally, this position consists of the operation of moderately complex semi-automated equipment.
This role is located in Athens, Ohio.
The Responsibilities
Ensures product quality in all manufacturing operations by being alert and observant to detect problems and/or potential problems with equipment or product.
Responsible for running in-process, chemistries release, calibration, and experimental devices, notifying appropriate personnel of results and completing all associated documentation.
Responsible for scheduling of biochemistry production and testing activities
Responsible for training and the documentation of training for all Molecular Biochemistry personnel
Responsible for the completeness and accuracy of manufacturing documents
Responsible for retrieving and compiling data associated with all device testing and notifying the appropriate personnel if results are not in compliance.
Operate laboratory equipment safely, as trained and directed, per established practices.
Oversee daily operations of the laboratory and completion of instrument logs.
Responsible for inventory accuracy of all testing-related materials.
Responsible for equipment maintenance and communication with external vendors for service calls or reports of equipment malfunction
Responsible for coordinating complaint investigations with the testing team.
Responsible for completion of NCMRs and other quality documentation
Responsible for Pre-delivery Sample testing program
Carries out duties in compliance with established business policies.
Perform other duties & projects as assigned.
The Individual
Required:
Bachelor’s degree in science, or equivalent combination of relevant work experience and education.
Three to five years of related experience required.
Demonstrated mastery of all relevant and associated Production and Quality Biochemist skills.
Advanced skills in Microsoft Office Suite; strong knowledge of Excel.
Strong communication skills
Knowledge of aseptic techniques and Biological Safety practices
Ability to read, interpret and follow detailed procedures, instructions and drawings.
Chemistry and laboratory skills, GLP/GMP experience
Demonstrated team-oriented interaction skills/professional behavior.
Strong written and verbal communication skills.
Must understand traceability (product, material, and calibration).
Demonstrates commitment to the development, implementation and effectiveness of QuidelOrtho Quality Management System per ISO, FDA, and other regulatory agencies.
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Preferred:
Master’s degree
2 years of related experience in a lead capacity
Ten key adding machine experience preferred.
The Key Working Relationships
Internal Partners:
Quality Control Chemists/Supervisor, Manufacturing, Materials & Warehousing, R&D, Quality Engineering, IT and Facilities
External Partners:
Vendors
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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