At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
The Supervisor, Sample Management, 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. It is a 'working' supervisor role requiring time split preferentially towards in lab, but office duties as well.
This role requires a shift schedule of Monday-Friday, 1:00pm-9:00pm EDT.
Essential 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
Contributes to oversight of Sample Management laboratory, including storage units and other equipment, under supervision of senior management
Executes 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
Execute internal post task execution audits to ensure completion according to standards and SOPs
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.
Minimum Preferred Qualifications: 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
Preferred Experience
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
Supervisory Responsibility
Sample Management Technicians
Sample Management Specialists
May supervise Data Management Specialists
Supervision Received
Infrequent supervision and instructions
Frequently exercises discretionary authority
Working Environment
Lab and office environment
Use of personal protective equipment such as safety glasses, lab coats, and gloves
Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
Potential exposure to biological fluids with possible exposure to infectious organisms (lab)
Potential exposure to skin and lung irritants, toxic materials, and hazardous waste (lab)
Exposure to fluctuating temperatures on rare occasions (lab, loading dock)
Physical Demands
Ability to work in an upright and/or stationary position for up to 8 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
Frequent mobility needed
Occasional crouching or stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moving) objects, including laboratory samples, laboratory equipment, and laptop computer, with a maximum lift of 30 pounds
Ability to use personal protective equipment and work effectively in freezers as cold as -80°C
Ability to access and use a variety of computer software
Ability to communicate information and ideas so others will understand, with the ability to understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance
Position Type and Expected Hours of Work
This is a full-time position with a shift schedule of Monday-Friday, 1:00pm-9:00pm
Some weekend, holiday, and evening work required
Additional Information
BENEFITS AND OTHER PERKS
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
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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