Data Management Specialist

BioAgilytix Labs, LLC; Durham (NC); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Account

Disability Insurance

Paid Time Off

Parental Leave

Paid Holidays

401k

Job summary

BioAgilytix is seeking a Data Management Specialist to handle GxP-compliant data processing within the Sample Management group. The role involves creating and maintaining records, building sample metadata in LIMS, preparing manifest files, and ensuring data integrity across systems.

You will also resolve discrepancies, develop SM software solutions, collect metrics, and assist with audits and training. The position requires strong attention to detail and extensive knowledge of LIMS and QMS

Qualifications

• High School diploma and not less than eight (8) years' experience in sample management in a biotech or pharmaceutical GxP-regulated environment
• 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 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
• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Responsibilities

• Generates and maintains records in a GxP-compliant manner
• Builds study sample metadata in LIMS
• Prepares sample manifest files for import into electronic sample management systems (eSMS)
• 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
• Trains new Sample Management Specialists
• Assists with drafting Sample Management SOPs
• Recommends/enacts process improvements
• 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 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

Skills

GxP compliance

MS Excel

MS Word

LIMS

Quality Management software

Data integrity

Education

High School diploma

Associate degree in biological science or related field

Bachelor's degree in biological science or related field

Tools

LIMS

eSMS

Quality Management software

Job description

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.

• Generates and maintains records in a GxP-compliant manner
• Builds study sample metadata in LIMS
• Prepares sample manifest files for import into electronic sample management systems (eSMS)
• 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
• Trains new Sample Management Specialists
• Assists with drafting Sample Management SOPs
• Recommends/enacts process improvements
• 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 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

• High School diploma and not less than eight (8) years' experience in sample management in a biotech or pharmaceutical GxP-regulated environment
• 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 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
• Infrequent supervision and instructions
• Frequently exercises discretionary authority

• This is a full-time, on-site 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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