Data Management Specialist

Lever, Inc.; Durham, Northern (NC, KY); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Flexible Spending Account

Short/Long Term Disability

Life Insurance

Paid Time Off

Parental Leave

Paid Holidays

401k with Employer Match

Employee Referral Program

Job summary

BioAgilytix in Durham, NC is seeking a Data Management Specialist to ensure GxP-compliant data processing within the Sample Management group.

You will build study metadata in LIMS, prepare manifests for eSMS, resolve discrepancies, and ensure data integrity while supporting audits and SOP development. Collaboration across teams and training of staff are part of the role.

Qualifications

• Bons conhecimentos de GxP e requisitos regulatórios.
• Habilidade de trabalhar em equipe com múltiplos projetos.
• Atenção a detalhes, organização e boa comunicação.
• Proficiência em Excel/Word e experiência com LIMS/QA software.

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 regulations

Attention to detail

Organizational skills

Oral and written communication

MS Excel

MS Word

LIMS

Quality Management software

Education

High School diploma

Associate degree in biological science

Bachelor’s degree in biological science

Tools

LIMS

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.

Essential 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

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

Minimum Preferred Qualifications: 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

Preferred Credentials

• 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

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Position Type and Expected Hours of Work

• 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.