Sample Management Technician

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them. In this San Diego onsite role, the Sample Management Technician is responsible for GxP-compliant processing of incoming samples and reference materials. Essential Responsibilities

Accessions samples into LIMS

Imports electronic sample data into eSMS

Provides timely notification of sample receipt to appropriate client/study personnel as needed

Maintains sample chain-of-custody

Reviews study sample demographic data to confirm consistency between sample labels, study paperwork, and electronic sample management systems (eSMS)

Resolves discrepancies, with responsibility for investigating and correcting sample anomalies

Stages samples for testing per schedule/request

Checks out pre-test samples and checks in post-test samples

Ensures samples are ready for analysis on time via sample accessioning and staging schedules

Manages pre- and post-test sample storage

Maintains operability of sample storage units (e.g. routine maintenance, temperature monitoring)

Ships samples to domestic or international destinations

Dispositions samples as directed by client

Provides information for QAU, client, or regulatory agency audit reports as needed

Generates and maintains records in a GxP compliant manner

Assists in collecting metrics data as needed

Recommends process improvements

May receive samples as needed:

Receives shipments into Sample Management

Initiates sample chain-of-custody

Provides timely notification of sample receipt to client/BPM

May manage sample-related data as appropriate:

Builds study sample metadata in LIMS

Prepares sample manifest files for import into eSMS

Follows BAL SOPs

Other duties as needed

Minimum Preferred Qualifications - Education/Experience:

High school diploma

Minimum Preferred Qualifications - Skills:

Ability to work under GxP regulations

Ability to work under CAP/CLIA/NYS regulations

Ability to work in a fast-paced team environment where multiple concurrent projects must be completed in a timely manner

Ability to take direction well and multi-task

Acute attention to detail and excellent organizational skills

Excellent oral and written communication skills

Ability to quickly build proficiency in MS Excel, MS Word, LIS, LIMS and Quality Management software

Preferred Credentials:

Experience with shipping and receiving procedures

Familiarity with CAP/CLIA/NYS regulations in a laboratory environment

Familiarity with GxP regulations in a laboratory environment

Experience using Watson LIMS

Experience using Orchard Harvest LIS

Working Environment

Primarily laboratory environment, including use of personal protective equipment such as safety glasses, lab coats and gloves

Occasional loading dock environment

Occasional office environment

Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Exposure to biological fluids with potential exposure to infectious organisms

Potential exposure to skin and lung irritants, toxic materials, and hazardous waste

Exposure to fluctuating temperatures on rare occasions

Physical Demands

Ability to transition between sitting, standing and walking for up to eight (8) hours per day

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab and office equipment

Frequent mobility needed

Occasional crouching or stooping, with frequent bending and twisting of upper body and neck

Light to moderate lifting and carrying (or otherwise moving) objects, including laboratory samples, laboratory equipment, and laptop computer, with a maximum lift of 30 pounds

Ability to use personal protective equipment and work effectively in freezers as cold as -80C

Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences

Frequently interacts with others to obtain or relate information to diverse groups

Requires multiple periods of intense concentration

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence

Ability to perform under stress and multi-task

Regular and consistent attendance

Position Type and Expected Hours of Work

This is a full-time position

Some flexibility in hours is allowed, but the employee must be available during the "core" work hours as published in the BioAgilytix Employee Handbook

Occasional weekend, holiday, and evening work required