Manages client pulls and shipping requests. Supervises and provides regular feedback to employees, including mid-year and annual reviews. Identifies training needs and provides and/or coordinates training for employees to maintain high level of knowledge and ensure continuous compliance to appropriate laws, regulations, and company policy. Oversees daily activities in a cold-chain, biobanking, repository operation. Participates in operational planning, repository task assignment, and budgeta... more details
Work Schedule
Other
Environmental Conditions
Office
Job Description
At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com.
Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Operations Supervisor in the CBRO government contract oversees daily operations of the repository and operations technicians engaged in the receipt, data entry, storage and shipment of biological materials. Additionally, the Operations Supervisor is responsible for ensuring quality errors associated with the Inventory Database(s) are caught and resolved quickly.
Essential Duties and Responsibilities:
- Manages client pulls and shipping requests.
- Supervises and provides regular feedback to employees, including mid-year and annual reviews.
- Identifies training needs and provides and/or coordinates training for employees to maintain high level of knowledge and ensure continuous compliance to appropriate laws, regulations, and company policy.
- Oversees daily activities in a cold-chain, biobanking, repository operation
- Participates in operational planning, repository task assignment, and budgetary discussions
- Prepares and updates Standard Operating Procedures (SOPs) and Standard Work Instructions (SWIs); ensures employees follow standard operating procedures, safety procedures and quality control processes; monitors employees work for accuracy, completeness and productivity using established metrics; utilizes appropriate metrics to improve the operational procedures.
- Prepares or ensure preparation of monthly client reports, as appropriate; ensures components of the monthly reports are accurate.
- Identifies records, investigates, and assigns investigations for deviations and customer complaints in tracking database, develops and implements CAPAs, and ensures such activities are documented in accordance with SOPs.
- Interacts with employees, upper level management, and external clients to resolve discrepancies, deviations, incidents and to update inventory data.
- Oversees facility-related operations such as biological waste disposal, freezer monitoring system, equipment logs, facility logs and freezer installation/repair.
- Ensures all operational materials, supplies and needs are scheduled or ordered.
- Develops, maintains, and updates client-specific databases.
- Ensure necessary repository equipment are procured and scheduled for major/minor preventive maintenance.
- Manages and participates in the after-hours on-call program.
- Other duties may be assigned to meet business needs.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
- Requires knowledge of Universal Precautions, safe handling and disposal of biological materials.
- Requires knowledge and certification in DOT and IATA regulations.
- Requires knowledge of quality assurance and control procedures.
- Ability to communicate effectively with all levels of technical and professional personnel.
- Demonstrated proficiency in Microsoft Windows; primarily Outlook, Word, Excel, and Access.
- Excellent leadership, interpersonal, problem-solving, planning and organizational skills.
- Requires knowledge of basic facility/operational functions.
- Prefer knowledge of current Good Manufacturing Practices (cGMP).
- Prefer knowledge of In-Trak, Nautilus, and TrackWise.
Education/ Experience:
- Requires High School diploma or equivalent; Prefer Bachelor’s degree in a scientific field.
- Requires 4+ years experience in a biological repository or similar environment.
- Requires 4+ years of experience in inventory management.
- Prefer 1+ years of supervisory experience.
Certificates and/ or Licenses:
None.
Supervisory Responsibility:
Manage operations technicians as well as general repository operations.
Work Schedule:
8:00AM to 4:30PM core hours, additional hours as required.
Work Conditions/Physical Requirements:
- Must be able to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-196°C).
- Must be able to work in walk-in freezers or refrigerators periodically.
- Must be able to use a computer up to 6 hours per day.
- Must be able to work in a laboratory and warehouse/repository environment.
