Supervisor, Sample Management

About the role

The Supervisor, Sample Management at BioAgilytix is responsible for supervising a team of Technicians and Specialists to ensure timely and accurate GxP/CDX-compliant processing of incoming and outgoing samples and reference materials. This role requires a shift schedule of Monday-Friday, 1:00pm-9:00pm EDT.

Responsibilities

• Supervises a team of Technicians and 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 regulatory (GxP, CDX-CAP/CLIA) compliant processing of samples; and scheduling the work of team members under the oversight of senior management
• Supervises the professional development of direct reports
• Conducts performance reviews
• Coaches toward professional success
• Coordinates with study personnel (e.g., project Supervisor, project managers, coordinators) to prioritize departmental tasks for on time delivery
• Resolves incidents, initiating deviations, and CAPA's, when appropriate, under the supervision of the Manager, Sample Management
• Enacts process improvements
• Ensures data integrity and traceability
• Writes/reviews Sample Management SOPs and other associated SOPs as required
• Participates in training technician and specialists when appropriate
• Participates in external audits/inspections; may lead tours of sample management area
• Generates and maintains records in a regulatory compliant manner
• Executes internal post task execution audits to ensure completion according to standards and SOPs
• Fulfills Technician and 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 and/or LIS, Manages pre-and post-test sample storage, Pulls and checks out samples for testing; checks in samples after testing

Qualifications

• Education/Experience: High School diploma and not less than six (6) years’ experience in sample management in a biotech or pharmaceutical GxP-regulated environment. Previous people leadership experience, including supervising, coaching, mentoring, or developing team members, is preferred. Associate degree in biological science or related field and not less than four (4) 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 three (3) years’ experience in sample management or related field in a biotech or pharmaceutical GxP-regulated environment.
• Skills: In-depth knowledge of GxP and/or CDX regulations, specifically as they relate to Sample Management. Ability to lead 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.

Benefits

• 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