Covance Medical Technologist Associate
Play a pivotal role in the drug development process and grow your career
Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities?
If you are looking for a company where you can gain exposure to a wide variety of science and explore a multitude of career paths across the drug development spectrum, consider working at Covance
- Perform testing that is related to method validations and instrument validations according to Standard Operating Procedure (SOP) but does not include reporting patient results.
- Prepare workstation and instrumentation for the assigned testing.
- Receive, open and place in service all reagents according to SOPs.
- Prepare and properly label reagents and document according to SOPs.
- Operate instruments to perform testing in accordance with established written procedures.
- Resolve routine and non-routine assay problems.
- Perform parallel testing, reagent validation, linearities, and stability studies.
- Thoroughly and completely document all experiments performed, including reagents and equipment used.
- Prepare Method Validation Experimental Plan, EP Evaluator documents and Statement of Claims Summary Reports according to SOP.
- Ensure the validity of test results through the performance of established quality assurance and quality control procedures. Interpret quality control results according to Westgard rules or other established departmental procedures.
- Prepare quality control material accurately.
- Document quality control results. Check for and acknowledge biases, warnings, and violations of control rules.
- Prepare proper documentation of test results and enter the information completely and accurately into the appropriate validation binder.
- Generate an appropriate audit trail for all activities.
- Ensure signature and dating of all steps conforms to SOP and accepted Covance CLS practices for documentation of results.
- Ensures maintenance of instruments and equipment is performed according to manufacturer and SOP requirements, and documented according to SOP.
- Calibrate instruments, equipment, and/or assays as required and document.
- Perform basic instrument and equipment troubleshooting.
- Perform pipette calibrations and document according to SOP.
- Notify laboratory management when an instrument or equipment does not meet specifications.
- Comply with regulatory guidelines and Covance Standard Operating Procedures (SOPs) at all times.
- Individual is responsible for maintaining his/her complete up-to-date training file, and is accountable for correcting any deficiencies found in his/her training file.
- Individual is responsible for ensuring he/she is trained, and training is documented prior to performing a task.
- The individual successfully completes, as scheduled, competency assessment, and ensures competency testing documentation is provided to management for review/retention.
- Competently performs department duties as set forth in the department training checklist(s).
- May assist in training new employees and follows-up to ensure training is understood.
- Attends, as scheduled, department, mandatory, and other meetings and training, as required according to training matrices
- Work to achieve partnership with both internal customers and external clients by:
- Pull data in a timely manner for review by QA and external clients.
- Contribute to the provision of accurate verbal or written response to internal QA and client audit findings. Coordinate, where needed, with other resources to resolve issue.
- Researches and prepares a response following investigation for quality purposes. Coordinate, where needed, with other resources to resolve issue.
- Research and respond in a timely manner to internal customer inquiries regarding status of test results, retrieval of samples for testing/storage, and other needs.
- Understand department metrics and goals.
- Demonstrate proficiency in applicable computer systems and software.
- Adheres to established Safety policies and Universal Precaution guidelines at all times. Maintains a clean, organized and safe work environment. Minimizes biohazard waste. Cleans workstation and materials daily.
- Takes action for the department when additional responsibilities and opportunities are presented.
- Provide laboratory management with a report of activities upon request.
- Other duties as assigned.
Individual must qualify as testing personnel under the following CLIA 1988 and New York State
Department of Health requirements:
• Bachelor's degree in a chemical, physical or biological science from an accredited college
• 90 semester hours from an accredited institution that include the following:
1) 16 semester hours of biology courses, which are pertinent to the medical sciences
2) 16 semester hours of chemistry (at least 6 semester hours of Inorganic Chemistry)
3) 3 semester hours of math
- Experience with lab instruments & pipetting skills
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