Senior Operations Technician - BioServices

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

POSITION SUMMARY

The Senior Operations Technician - Bioservices role is responsible for ensuring all operational activities are executed accurately and timely, following specific procedures and processes as defined in Work Instructions created by Program Managers.

The Senior Operations Technician - Bioservices involves the receipt, inventory, storage, withdrawal, packaging, labeling, and shipment of biological materials, therapeutic products, clinical agents, and materials from multiple commercial and government clients. This position may also participate in the assembly of various types of kits and label printing. These materials are stored at temperatures ranging from ambient (room temperature) to below freezing (including cryogenic) with potentially hazardous properties. Also, liaising with Program Managers to provide support with the scheduling of work and supervision of staff, writing and updating SOP's and other project-related 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.

• To undertake packaging and labeling of pharmaceutical products at all temperatures (including low and ultra-low temperatures) according to standard operating procedures

• Assemble a range of kit types according to strictly defined client specifications.

• To assist in SOP development and revisions.

• To assist in deviation investigations and change control documentation.

• To provide supervision of project technicians and project activities as required.

• Scheduling of project work, accounting for deadlines, available resources, and business needs.

• Disseminating information from and providing feedback to Project Managers.

• Coordinate stock management and receipt of kit production, packaging and labeling components.

• Assists with Quality Control tasks such as verification, validation and calibration procedures as required.

• 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.

• Primary responder to all equipment alarms and an active member of the site" On- Call” team -  responding to all alarms, including out-of-hours (24/7 on a rotating cycle with other team members).

• 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.

• Documents in response to the temperature monitoring systems.

• Works around hazardous substances and follows all safety guidelines to minimize exposure.

• Assures compliance to cGMP requirements and company quality systems.

• Maintains cGMP training records and participates in staff quality training.

• Ensures all job-related paperwork is c01Tect, error-free, and completed in real-time as per SOP's.

• Responsible for complying with company and HR policies and procedures.

• Ensuring adequate and accurate documentation for all procedures is maintain.

• Writing (and changing, via Change Control process) appropriate SOP's for all operational procedures.

• Ensure all activities are carried out in accordance with health, safety, and environmental statutory, regulatory, and company regulations.

• Always ensure strict client confidentiality.

• To participate and contribute to operational excellence and process improvement projects that cost-effectively deliver the business objectives.

• Assist in the supervision of temporary contract staff as required.