Astrix Technology Group is a recognized leader in Scientific Staffing and Recruiting.

As a company of scientists, we have the resources and expertise to find the right position especially when you need it most.

We have partnerships with leading companies in all scientific industries across the country.

Incorporated since 1995, our business has succeeded by creating value and trust with our clients and candidates.

We speak your language! And, best of all, Astrix offers full medical benefits with company contribution, PTO, holidays and much more!We have an excellent CONTRACT-TO-HIRE opportunity for a Clinical Supply Associate II for a leading biopharmaceutical company in the New Jersey area! ResponsibilitiesImplements/Executes supply chain activities within the Clinical Production Department.

Responsibilities will include, but are not limited to, the following: Works directly with the Operations Engineer to develop, implement, and execute all aspects of the PDA001 supply chain.

Orchestrates procurement and inventory management of materials Works closely with Clinical Production to understand qualitative and quantitative needs of materials and communicates these to vendors to obtain the best quality material.

Works closely with Developmental Quality Control to assure that materials are sourced in a manner that gets them through the qualification requirements without delaying production.

Prepare Raw Material Monographs to meet Clinical Production needs.

Distribution of drug product and placebo to clinical trial sites Respond to drug product requests from the study manager.

Prepare, document, ship, and track clinical materials.

Liaise with couriers to coordinate/facilitate pickups and deliveries Maintain sufficient inventory at each of the clinical sites.

Coordinate the destruction of expired inventory and returns.

Compiles, reviews, and reports shipping data and temperature logs.

Maintenance of Dry Shipper Fleet Performs qualification of dry shippers and data loggers Performs verification monitoring and inspection of returned units Promptly identify and escalate risks to clinical trial or production timelines, from a supply chain perspective, to the technical operations team.

Authors non-conformance reports and CAPA.

Assists in the development of departmental policies and SOPs QualificationsBS in Project Management, Industrial Engineering, Chemistry, Biology, or related discipline.

2-3 years of relevant experience preferred (experience with cryopreservation is ideal)Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs).

Must be able to communicate effectively with other CCT functional areas, and accrediting and regulatory agencies.

Must have excellent organization skills and ability to handle multiple tasks.

Highly motivated, willingness to acquire new skills and ability to work with minimal supervision.

Must have project management and logistics knowledge applicable to supply chain coordination.

Knowledge of cGMPs /cGLPs and SOP development would be advantageous.

Excellent verbal and written communication skills Working knowledge of domestic import/export requirements a plus A basic knowledge in various computer applications.

Ability to work with Microsoft Word and Excel required.

Ability to perform frequent physical tasks with strength and mobility.

Daily tasks call for extensive walking, standing and occasional lifting of heavy materials.

Employees must work in areas where posted Universal Precautions must be observed and practiced.

There is repeated contact with potential infectious blood products with subsequent risks of acquired infections.

Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.

If you would like to be considered for this exciting opportunity, please send a copy of your resume to recruit [at] astrixtechgroup [dot] com with Clinical Supply Associate in the subject line.

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