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