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.
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:
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.
