Manager, Sample Management at BioAgilytix Labs in Durham, NC

The Manager, Sample Management is responsible for managing a team of Technicians, Specialists, and Data Management Specialists to ensure timely and accurate GxP-compliant processing of incoming and outgoing samples and reference materials.

Essential Responsibilities

• Manages a team of Technicians, Specialists and Data Management Specialists, including but not limited to ensuring all team members are trained and able to successfully complete all responsibilities; responsible for overseeing on-time availability of samples and GxP-compliant processing of samples; and scheduling the work of team members
• Manages the professional development of direct reports
• Conducts performance reviews
• Coaches toward professional success
• Coordinates with study personnel (e.g., project manager, study coordinator) to prioritize accessioning requests
• Resolves discrepancies, initiating deviations, and CAPA's when appropriate
• Enacts process improvements
• Ensures data integrity and traceability
• Writes/reviews Sample Management SOPs and other associated SOPs as required
• Participates in audits/inspections; may lead tours of sample management area
• Responds to QAU, client, and regulatory agency audit reports
• Develops and presents Sample Management metrics to department director and/or leadership team
• Generates and maintains records in a GxP-compliant manner
• Oversees Sample Management laboratory including storage units and other equipment
• May execute Technician, Specialist, and/or Data Management Specialist responsibilities including but not limited to:
• Receives shipments into Sample Management
• Initiates sample chain-of-custody
• Provides sample receipt notification
• Ships samples to domestic and international destinations
• Manages final disposition of study samples
• Accessions samples into LIMS
• Compiles and imports sample metadata into Laboratory Information Management System (LIMS)
• Manages pre-and post-test sample storage
• Pulls and checks out samples for testing; checks in samples after testing
• Builds study sample metadata in LIMS
• Prepares sample manifest files for import into LIMS
• Develops/validates Sample Management software solutions
• Communicates with clients as needed
• Follows BAL SOPs
• Other duties as assigned

Minimum Acceptable Qualifications

Education/Experience:

• High School diploma and not less than ten (10) years' experience in sample management in a biotech or pharmaceutical GxP-regulated environment

Skills:

• In-depth knowledge of GxP regulations, specifically as they relate to Sample Management
• Ability to lead and manage a team 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
• Assessment of risk and determination of root cause for non-compliances related to management of study samples

Preferred Credentials

• Associate degree in biological science or related field and not less than eight (8) years' experience in sample management or related field in a biotech or pharmaceutical GxP-regulated environment
• Bachelor's degree in biological science or related field and not less than six (6) years' experience in sample management or related field in a biotech or pharmaceutical GxP-regulated environment