High School diploma with 8+ years in sample management in a GxP-regulated environment, or
Associate degree with 6+ years in sample management in a GxP-regulated environment, or
Bachelor's degree with 4+ years in sample management in a GxP-regulated environment
Working knowledge of GxP regulations
Proficiency in MS Excel, Word, LIMS, and Quality Management software
Responsibilities
Generate and maintain GxP-compliant records
Resolve discrepancies and update electronic information
Ensure data integrity and traceability
Develop and validate Sample Management software solutions
Collect and present metrics data
Participate in audits and inspections as needed
Assist in drafting Sample Management SOPs
Benefits
Medical, Dental, and Vision Insurance
Flexible Spending Account for medical and dependent care
Short and Long Term Disability Insurance
Life Insurance
4 weeks Paid Time Off per year
Parental Leave
401k with Employer Match
Employee Referral Program
Full Job Description
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
Additional Responsibilities
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
$70,000 - $75,000 an hour
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
About BioAgilytix Labs
BioAgilytix Labs is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina?s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, and GCP, as well as product release testing under GMP.
