Data Management Specialist

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.

The Sample Management Specialist is responsible forGxP-compliant processing of incoming and outgoing samples and reference materials.  

• 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 with drafting sample management SOPs as needed
• Collects metrics data as needed
• Recommends process improvements
• May serve as a trainer for new Sample Management Technicians
• 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

• High School diploma and not less than six (6) years’ experience in a GxP-regulated laboratory or sample management environment; sample management experience preferred

• 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

• Associate degree in biological science or related field and not less than four (4) years’ experience in a GxP-regulated laboratory or sample management environment; sample management experience preferred
• Bachelor’s degree in biological science or related field

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

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.