♦ Utilize knowledge and experience with histology samples to maintain proper storage conditions and facilitate accessioning of blocks and slides (stained and unstained). Routine decalcification, processing, embedding, microtomy and re-embedding of human tissue specimens from patients enrolled in clinical trials. Perform Immunohistochemistry and FISH testing according to protocols and SOPs. Perform slide scanning as required and according to protocols.
♦Perform assigned clinical laboratory testing accurately and in a timely manner, in accordance with established written procedures. Resolves routine and non-routine assay problems.
♦ Ensure the validity of tests results through the performance of established quality assurance and quality control procedures. Evaluation of new calibrator and/or QC lots, summarize investigations for review by management, documetnation of QC results, analyze proficiency testing survey samples as patient specimens.
♦ Reagents/Materials/Supplies: Receive, open and place in service all reagents/materials according to SOPs. Perform inventory control of supplies and reagents as approved by management.
♦ Result Entry (Auto-verification and manual entry). When data is manually entered (e.g. QC, patient data) ensure peer review is performed and documented prior to release of results. Prepare proper documentation of test results and enter into the information system. Generate an appropriate audit trail for all activities. Document and communicate any result reporting problems or inconsistencies to laboratory management. Complete testing within the expected turnaround time to meet customers’ expectations.
♦ Ensures maintenance of instruments and equipment is performed according to manufacturer and SOP requirements, and documented according to SOP. Perform basic instrument and equipment troubleshooting.
♦ Comply with regulatory guidelines and Covance Standard Operating Procedures (SOPs) at all times.
♦ Training: Individual is responsible for maintaining his/her complete up-to-date training file and is accountable for correcting and 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). 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.
♦ 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.
♦ Other duties as assigned.
Bachelor’s degree in biological sciences/biomedical sciences/Medical Technology preferred from an accredited college or university.
at least 1 year previous experience in histology laboratory