TalentBurst
Overview
The Clinical Laboratory Specialist (2nd shift) in San Marcos, TX is a 6-month role (12:00 PM - 08:30 PM CST) focused on supporting day-to-day clinical and manufacturing operations for *** Laboratory Solutions Inc.
Responsibilities
Provide hands-on technical support for patient molecular/serologic and manufacturing testing of samples with the ability to perform and summarize data for review and reporting.
Participate in method validations and monitor daily, weekly, and monthly QC of equipment and systems.
Ensure duties are performed in regulatory compliance with operational efficiency.
Perform duties related to tests, instruments, and reagents; identify potential instrument or reagent problems and escalate to Lead.
Maintain a clean and organized workplace; ensure proper PPE and sample/material handling; log all incoming materials.
Maintain technical competencies and ensure annual competencies are up-to-date; align annual CE with competencies.
Perform high-/mid-complexity and simple routine tests; ensure accurate data transfer and electronic report generation; document final results and submit results for review.
Accession clinical samples in the Laboratory Information System (LIS); use LIS to sign off test completion and communicate results for review/release.
Report incorrect sample submissions to management; communicate written reports to clients.
Assist with training new employees for routine, moderate, and high-complexity tests; perform competency assessments of all staff.
Maintain strict adherence to SOPs, Quality System Essentials (QSE), cGMP, and regulatory guidelines.
Perform feasibility studies and assist management in the development of new assays; assist with strategic project testing and data summaries; participate in validation protocols and data summaries.
Perform equipment annual calibrations; use Microsoft tools to summarize daily, weekly, and monthly quality metric data.
Support deviations to SOPs in documentation (MediaLab) and use MediaLab to enter deviations and CAPA submissions/updates.
Maintain CE credits consistent with laboratory policy.
Knowledge, Skills, and Abilities
Practical knowledge of immunohematology and molecular procedures, including NAT testing.
Proficient in MS Office Suites; excellent organizational and teamwork skills; strong written and verbal communication abilities.
Ability to communicate with all levels of staff and management and interface with clients; proficient in technical writing for regulated documents.
Promotes teamwork and maintains positive employee morale.
Education One of the following required: Bachelors of Science Degree in immunology, genetics, molecular biology, or related field; CLS (ASCP) or equivalent is a plus.
Experience Entry: No previous experience required. Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus.
Occupational Demands Work is performed in both a lab and an office environment. Typical activities include sitting for 4-6 hours per day, occasional standing, walking, bending and twisting. Prolonged use of calibrated micropipettors with repetitive motion. Light to moderate lifting up to 50 lbs. Some travel within the United States. Ability to communicate complex information clearly and to understand instructions; ability to apply abstract principles to solve complex conceptual issues.
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Responsibilities
Provide hands-on technical support for patient molecular/serologic and manufacturing testing of samples with the ability to perform and summarize data for review and reporting.
Participate in method validations and monitor daily, weekly, and monthly QC of equipment and systems.
Ensure duties are performed in regulatory compliance with operational efficiency.
Perform duties related to tests, instruments, and reagents; identify potential instrument or reagent problems and escalate to Lead.
Maintain a clean and organized workplace; ensure proper PPE and sample/material handling; log all incoming materials.
Maintain technical competencies and ensure annual competencies are up-to-date; align annual CE with competencies.
Perform high-/mid-complexity and simple routine tests; ensure accurate data transfer and electronic report generation; document final results and submit results for review.
Accession clinical samples in the Laboratory Information System (LIS); use LIS to sign off test completion and communicate results for review/release.
Report incorrect sample submissions to management; communicate written reports to clients.
Assist with training new employees for routine, moderate, and high-complexity tests; perform competency assessments of all staff.
Maintain strict adherence to SOPs, Quality System Essentials (QSE), cGMP, and regulatory guidelines.
Perform feasibility studies and assist management in the development of new assays; assist with strategic project testing and data summaries; participate in validation protocols and data summaries.
Perform equipment annual calibrations; use Microsoft tools to summarize daily, weekly, and monthly quality metric data.
Support deviations to SOPs in documentation (MediaLab) and use MediaLab to enter deviations and CAPA submissions/updates.
Maintain CE credits consistent with laboratory policy.
Knowledge, Skills, and Abilities
Practical knowledge of immunohematology and molecular procedures, including NAT testing.
Proficient in MS Office Suites; excellent organizational and teamwork skills; strong written and verbal communication abilities.
Ability to communicate with all levels of staff and management and interface with clients; proficient in technical writing for regulated documents.
Promotes teamwork and maintains positive employee morale.
Education One of the following required: Bachelors of Science Degree in immunology, genetics, molecular biology, or related field; CLS (ASCP) or equivalent is a plus.
Experience Entry: No previous experience required. Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus.
Occupational Demands Work is performed in both a lab and an office environment. Typical activities include sitting for 4-6 hours per day, occasional standing, walking, bending and twisting. Prolonged use of calibrated micropipettors with repetitive motion. Light to moderate lifting up to 50 lbs. Some travel within the United States. Ability to communicate complex information clearly and to understand instructions; ability to apply abstract principles to solve complex conceptual issues.
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