Data Management Specialist

BioAgilytix • San Diego, CA

3d

About The Position

The Data Management Specialist is responsible for GxP-compliant processing of data within the Sample Management group at BioAgilytix. The role generates and maintains compliant records, resolves discrepancies, ensures data integrity and traceability, and develops or validates Sample Management software solutions. It also supports metrics, audits and inspections, SOP drafting, and process improvements. The position may include training new specialists and performing sample-receipt, shipping, accessioning, metadata, and storage activities using LIMS and electronic sample management systems.

Requirements

• High school diploma and at least eight years of sample management experience in a biotech or pharmaceutical GxP-regulated environment; or an associate degree in biological science or a related field and at least six years of such experience; or a bachelor's degree in biological science or a related field and at least four years of such experience.
• Working knowledge of GxP regulations.
• Ability to work in a fast-paced team environment and complete multiple concurrent projects in a timely manner.
• Ability to take direction and multitask.
• 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.

Responsibilities

• Generate and maintain records in a GxP-compliant manner.
• 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 appropriate.
• Provide information for QAU, client, or regulatory agency audit reports as needed.
• Assist with drafting Sample Management SOPs.
• Recommend and enact process improvements.
• May train new Sample Management Specialists and Data Management Specialists.
• Receive shipments into Sample Management and initiate sample chain-of-custody.
• Provide timely notification of sample receipt to the client or BPM.
• May ship samples to domestic or international destinations.
• May build study sample metadata in LIMS and prepare sample manifest files for import into electronic sample management systems (eSMS).
• Accession samples into LIMS and import electronic sample metadata into eSMS as needed.
• Investigate and correct sample anomalies and resolve discrepancies.
• Manage pre- and post-test sample storage.
• Pull samples for testing per schedule or request; check out pre-test samples and check in post-test samples.
• Follow BAL SOPs.
• Perform other duties as needed.

Benefits

• Medical insurance (HDHP with HSA or PPO)
• Dental insurance
• Vision insurance
• Flexible spending account for medical and dependent care
• Short-term and long-term disability insurance
• Life insurance
• Paid time off (four weeks per year)
• Parental leave
• Paid holidays (nine scheduled and five floating)
• 401(k) with employer match
• Employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED