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 Data Management Specialist is responsible for GxP-compliant processing of data within the Sample Management group.

Essential Responsibilities

• Generates and maintains records in a GxP-compliant manner
• Resolves discrepancies and updates electronic information
• Ensures data integrity and traceability
• Develops/validates SM software solutions
• Collects and presents metrics data
• Participates in audits/inspections as appropriate
• Provides information for QAU, client, or regulatory agency audit reports as needed
• Assists with drafting Sample Management SOPs
• Recommends/enacts process improvements
• May train new Sample Management Specialists
• May train new Data Management Specialists as needed
• 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 ship samples to domestic or international destinations as needed
• May build study sample metadata in LIMS
• May prepare sample manifest files for import into electronic sample management systems (eSMS)
• May accession samples as needed:
• Accessions samples into LIMS
• Imports electronic sample metadata into eSMS
• Resolves discrepancies, with responsibility for investigating and correcting sample anomalies
• Manages pre- and post-test sample storage
• Pulls samples for testing per schedule/request
• Checks out pre-test samples and checks in post-test samples
• Follows BAL SOPs

• Other duties as needed

Minimum Preferred Qualifications

Education/Experience:

• High School diploma and not less than eight (8) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment
• Associate degree in biological science or related field and not less than six (6) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment
• Bachelor’s degree in biological science or related field and not less than four (4) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment

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

Supervisory Responsibility

• This position has no supervisory responsibilities

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• Primarily office environment
• Occasional laboratory environment, including use of personal protective equipment such as safety glasses, lab coats and gloves
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
• Potential exposure to biological fluids with possible exposure to infectious organisms (lab)
• Potential exposure to skin and lung irritants, toxic materials, and hazardous waste (lab)
• Exposure to fluctuating temperatures on rare occasions (lab, loading dock)

Physical Demands

• Ability to work in an upright and /or stationary position for up to 8 hours per day
• Ability to access and use a variety of computer software
• 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
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab/office equipment
• Frequent mobility needed
• Occasional crouching or stooping, including bending and twisting of upper body and neck
• Occasional 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
• 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.

 

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