GxP Sample Management Technician — Fast-Paced Lab

BioAgilytix Labs; San Diego (CA); On-site; USD 26,000 - 36,000; Full time

Benefits offered by this job

Medical Insurance (HDHP with HSA; PPO)

Dental Insurance

Vision Insurance

Flexible Spending Account (medical; D9

Short/Long 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

Job summary

BioAgilytix Labs is seeking a detail-oriented sample management professional to accession, track, and ship laboratory samples in a fast-paced GLP/GxP environment. You will manage data in LIMS/eSMS, maintain chain-of-custody, and support audits and regulatory reporting while ensuring timely availability of samples for testing.

Primary duties include data entry, sample storage, shipment coordination, and adherence to CAP/CLIA/NYS regulations.

Qualifications

• Ability to work under GxP regulations
• Ability to work under CAP/CLIA/NYS 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
• Ability to quickly build proficiency in MS Excel, MS Word, LIS, LIMS and Quality Management software

Responsibilities

• Accession samples into LIMS
• Import electronic sample data into eSMS
• Provide timely notification of sample receipt to appropriate client/study personnel as needed
• Maintain sample chain-of-custody
• Reviews study sample demographic data to confirm consistency between sample labels, study paperwork, and electronic sample management systems (eSMS)
• Resolves discrepancies, with responsibility for investigating and correcting sample anomalies
• Stages samples for testing per schedule/request
• Checks out pre-test samples and checks in post-test samples
• Ensures samples are ready for analysis on time via sample accessioning and staging schedules
• Manages pre- and post-test sample storage
• Maintains operability of sample storage units (e.g. routine maintenance, temperature monitoring)
• Ships samples to domestic or international destinations
• Dispositions samples as directed by client
• Provides information for QAU, client, or regulatory agency audit reports as needed
• Generates and maintains records in a GxP compliant manner
• Assists in collecting metrics data as needed
• Recommends process improvements
• 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 manage sample-related data as appropriate: Builds study sample metadata in LIMS
• Prepares sample manifest files for import into eSMS
• Follows BAL SOPs
• Other duties as needed

Skills

GxP regulations

CAP/CLIA/NYS regs

Fast-paced teamwork

Multi-tasking

Attention to detail

Oral and written comms

Excel/Word/LIS/LIMS

Education

High school diploma

Tools

Watson LIMS

Orchard Harvest LIS

Job description

BioAgilytix Labs is seeking a detail-oriented sample management professional to accession, track, and ship laboratory samples in a fast-paced GLP/GxP environment. You will manage data in LIMS/eSMS, maintain chain-of-custody, and support audits and regulatory reporting while ensuring timely availability of samples for testing.

Primary duties include data entry, sample storage, shipment coordination, and adherence to CAP/CLIA/NYS regulations.