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
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
