GxP Data Management & Compliance Specialist

BioAgilytix Labs, LLC; San Diego (CA); On-site; USD 70,000 - 75,000; 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 with Employer Match

Employee Referral Program

Job summary

BioAgilytix Labs, LLC is seeking a Data Management Specialist to perform GxP-compliant data processing within the Sample Management group. The role emphasizes data integrity, traceability, and developing SM software solutions to support audits and client reporting.

The position involves handling sample receipt, chain-of-custody, metadata in LIMS, and collaboration with QA and regulatory teams. A strong detail orientation and proficiency in Excel are essential.

Qualifications

• 8+ years in sample management in a biotech or pharma GxP-regulated environment.
• Associate degree in biological science or related field with 6+ years experience.
• Bachelor's degree in biological science or related field with 4+ years experience.

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 audits/reports as needed.
• Assists with drafting Sample Management SOPs.
• Recommends/enacts process improvements.
• May train new Sample Management Specialists and Data Management Specialists.

Skills

GxP regulations knowledge

Attention to detail

Multitasking

Oral & written communication

Education

8+ years in sample management

Associate degree in biological science or related field

Bachelor's degree in biological science or related field

Tools

MS Excel

LIMS

Quality Management software

Job description

BioAgilytix Labs, LLC is seeking a Data Management Specialist to perform GxP-compliant data processing within the Sample Management group. The role emphasizes data integrity, traceability, and developing SM software solutions to support audits and client reporting.

The position involves handling sample receipt, chain-of-custody, metadata in LIMS, and collaboration with QA and regulatory teams. A strong detail orientation and proficiency in Excel are essential.