Laboratory professionals with GxP compliance understanding and attention to detail will find this role in a regulated biotech environment.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Bioagilytix via Lever
Essential Responsibilities::
- Timely GxP-compliant receipt of reference material and/or incoming samples
- May initiate sample chain-of-custody paperwork and/or electronic records
- Provides timely notification of sample receipt to appropriate BAL/client personnel
- Generates and maintains records in a GxP compliant manner
- Manages sample receipt freezer inventory
- Collects metrics data required to monitor sample receipt processes
- Recommends process improvements
- May train new Sample Management Technicians
- May assist with disposition of samples
- May assist with internal transfer of samples from temporary freezers to permanent freezers
- Follows BAL SOPs
- May accession samples as needed
- Reviews study sample metadata to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS)
- Accessions samples into LIMS
- Imports electronic data into electronic sample management system (e.g. FreezerPro)
- Resolves discrepancies, with responsibility for investigating and correcting sample anomalies identified in the eSMS system
- Manage pre and post-test sample storage
- Pull/check out samples for testing
- Check in samples after testing
Minimum Preferred Qualifications: Skills:
- Working knowledge of GxP 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
- Proficiency in MS Excel and Word
- Proficiency in LIMS and Quality Management software packages
Additional Responsibilities:
- Other duties as needed
Minimum Acceptable Qualifications: Education/Experience:
- High school diploma
Minimum Acceptable Qualifications: Skills:
- Ability to work under GxP 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, LIMS and Quality Management software
Preferred Credentials:
- Experience with shipping and receiving procedures
- Familiarity with GxP regulations in a laboratory environment
- Experience using Watson LIMS
Supervisory Responsibility:
- This position has no supervisory responsibilities
Supervision Received:
- Frequent supervision and instructions
- Infrequently exercises discretionary authority
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
- 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 -80°C
- 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
- 1st Shift Working Hours: 9am-5pm, Monday-Friday with the potential to move to 7am-3pm
- 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
Source: Bioagilytix careers (Lever)