Reporting to the Client Service Manager, this role is responsible for ensuring all operational activities are executed accurately and timely, following quality procedures.
This role involves the direct interaction with client for receipt, inventory, storage, withdrawal, packaging, and shipment of biological materials, therapeutic products, clinical agents, and materials. These materials are stored at temperatures ranging from ambient (room temperature) to below freezing (including cryogenic) with potentially hazardous properties.
In addition, liaising with team members to provide support with scheduling of work, completing documents associated with SOPs, and additional repository activities.
PRIMARY RESPONSIBILITIES (include but are not limited to):
• To perform receipt and inventory management of biological materials (including therapeutic drug products), data entry, relocation, retrieval, packaging and logistics operations according to standard operating procedures.
• Direct correspondence with client for scheduling, inventory and address concerns or issues.
• Organizes and coordinates shipments to external sites, collecting appropriate documents and preparing biospecimens and related data for shipment per IATA specifications
• Processes incoming materials for storage
• Visually inspects specimens for quality and data accuracy, performs accurate data entry into electronic tracking system
• Works closely with supervisors to support customer inquiries, such as discrepancies in shipments and inventory maintenance
• Responsible for ongoing inventory of samples, including reviewing documentation, data entry and labeling as necessary
• Inventory Quality Control testing
• Proper use of any temperature monitoring equipment as per CryoGene procedures
• Reporting of any incidents (monitoring equipment failures, transport delays, discrepancies) to CryoGene management
• Compliance with quality system practices
• Ensures project work areas are kept clean and free of any possible safety hazards.
• Understands and uses the inventory management, temperature monitoring, and site infrastructure systems.
• To be available for infrequent overtime work as necessary and to be willing to attend site, out of hours in the case of emergency or extraordinary work requirement.
• Works around hazardous substances and follows all safety guidelines to minimize exposure.
• Assures compliance to cGMP requirements and company quality systems.
• Ensures all job-related paperwork is correct, error-free, and completed in real time as per SOPs.
• To effectively communicate to ensure all project related information is conveyed in a timely and comprehensive manner.
Exhibits appropriate behavior, language, and appearance all times on the job.
• Maintains a professional manner when problems/conflicts arise.
• Responsible for complying with all company and HR policies and procedures.
• Ensuring adequate, accurate documentation for all procedures is maintained
• Ensure all activities are carried out in accordance with health, safety and environmental statutory, regulatory and company regulations.
• Ensures strict client confidentiality at all times
• To participate and contribute to operational excellence and process improvement projects that deliver the business objectives in a cost effective manner.
• To perform any tasks that may be necessary to execute specific projects.
• To undertake any other additional duties as requested by the client services manager.
COMPETENCIES & PERSONAL ATTRIBUTES
• Good communication skills with client and team members.
• Understanding of quality systems in day to day processes
• Previous experience working with materials at ultra-low & cryogenic temperatures is desirable.
• Health, Safety and Environmental experience / qualification is desirable
• Flexible and adaptable with good interpersonal skills
• Able to analyze problems and define solutions.
• Able to work under pressure and to support others within team.
• Proficient computer skills, specifically with Microsoft Office Suite.
• Builds customer commitment
• Supports operational excellence (30/30)
• Focus on priorities (80/20)
• Teamwork, collaboration, and accountability (90/10)
• Emphasis on business growth
• Safety awareness
• Frequently required to type, sit, stand, walk, lift/carry up to 50lbs. Occasionally required to push/roll 280kg lb liquid nitrogen dewars and 4-500kg freezers (with support), and work from a platform ladder.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
• Bachelor’s Degree level, or equivalent
• Minimum 1-3 years’ experience working in a GMP / GxP environment
• Hands-on experience working with biological and/or pharmaceutical materials and drug product
• Good understanding of quality system
Interested individuals should email their resume to Leigh Anne Hill email@example.com