Thermo Fisher Scientific QA Life Science Technician, 1st shift in Rochester, New York
Under the direction of the Quality Assurance Lab Manager, is responsible for tests and experiments in support of documented procedures and work orders.
In addition to the responsibilities listed below the Lead LifeScience Technician in conjunction with the laboratory manager on occasion will supervise the work of QA Laboratory Technicians engaged in performing routine and specialized technical procedures, including planning laboratory work, evaluating work perfomed and handling procedural and technical laboratory problems. May design appropriate work schedules for subordinate employees and plans daily work assignments in order to maintain an adequate personnel complement for laboratory efficiency.
- Evaluate finished products using written methods and criteria. Approve or reject such products in accordance with these methods, criteria and specifications. Advise and consult with Manager on rationale for rejection.
Assigned test methods can include, as needed:
Cell culture tests (including maintenance of stock cell lines)
Conduct microbiological testing for quarterly sterility dose audit
Microbiological tests supporting sterilization validations
Immunological tests for antibody binding
Tests for contamination with:
Responsible for accurately and completely recording results and notifying the QA Lab Manager and/or QA Scientist upon observing or being notified by (a 3rd party laboratory) of an out of specification result (OOS) for both non-release and release QA testing.
Assist with and coordinate product stability shelf life and performance program.
Maintain proper records and documentation in support of responsibilities. Help develop new techniques, tools and fixtures in support of testing requirements.
Support activities associated with resolving product quality problems and customer complaints.
Schedule and maintain calibration of equipment utilized in product testing.
Provide assistance in customer audits under supervision.
Maintain work area so that it is conducive to performing product evaluations that allow for correct and accurate results.
Work with other QA Lab personnel to ensure commitments are met in the time allowed.
Provide assistance when needed to train other company personnel in the lab on procedures and equipment.
Help maintain required supplies for operation of the lab.
Perform all duties to support ISO, GMP, OSHA, EPA and QA Chemical Hygiene Plan.
Work on other projects as assigned which can include work from the Engineering area of the lab.
Minimum of a Bachelor’s Degree in Biology or related field, with a minimum of one year of related experience; or an Associate’s Degree in Biology or related field, with minimum of three years of appropriate laboratory experience.
A background in immunology, tissue culture, microbiology and molecular biology is desired.
The incumbent should have a basic understanding of statistics and automated data handling.
Incumbent must be capable of data interpretation and have command of basic laboratory skills.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.