Newark Metro Area, NJ
Supports Pharmaceutical Science and Technology (PS&T) Clinical Manufacturing Operations for Drug Product Development and Drug Substance Development departments
Responsibilities will include daily support of (cGMP) warehousing operations for Drug Product Development, Biologics and Drug Substance Development
Purpose of the Position:
The Material Handler, PS&T Warehouse Operations will be responsible for the daily processes associated with material receipts, movements, storage, distribution, documentation and shipments within the cGMP Clinical Manufacturing operations warehouse.
The Material Handler will follow established procedures and controls to ensure assigned tasks are complete and operations are completed in an efficient, accountable and safe manner.
As a member of the broader PS&T Clinical Manufacturing team, the Material Handler will work with internal and external stakeholders to meet department / group objectives and goals, cGMP, regulatory, safety and shipping compliance.
o Material Handler, PS&T Warehouse Operations will support the daily physical warehousing activities supporting cGMP compliance and Environmental compliance for the early phase clinical trial Drug Product and Drug Substance groups.
o Material Handler must be capable of operating fork truck, pallet jack, basic hand tools and ancillary warehousing equipment
o Position will support the daily operational activities associated with receiving of raw materials and consumables shipments, inspection and recording of incoming materials, all movements of materials through the DP / DS internal supply chain network, maintain storage of materials, and preparation for outbound materials shipments
o Supports cold-chain and hazardous material shipments ensuring compliance with stated conditions
o Follows established Standard Operating Procedures required for area operations
o Reports and assists in coordination in instances of extraordinary events that have an impact on the logistical activities. Supports area management and stakeholders (QC, QA, Operating Departments, Warehouse staff, EHS, material suppliers, facilities maintenance) as required
o Handles and expedites materials receipt, ensuring appropriate and timely sampling / inspection and transfer of incoming materials
o Adheres to procedures to maintain the warehouse in a compliant state and supports inspection readiness at all times.
o Monitors and reports on consumable inventory levels
o Partners with EHS staff for materials destructions and waste removal
o Adheres to all required corrective and preventative actions, deviation responses and investigations for warehouse operations
o Develop, maintain and actively manages relationships with customers and external partners in operation of the warehouse and operations activities
o Facilitates safe and healthy work environment and ensure compliance with all appropriate department and corporate Safety / Environmental policies and regulations
Required Competencies-Knowledge, Skills, and Abilities:
o Knowledge of cGMP/GDP/Pharmaceutical Operations regulations
o Knowledge and experience with cGMP warehousing operations; ERP system operation highly desirable.
o Knowledge of Globally Harmonized Systems of Classification and Labeling of Chemicals (GHS)
o Knowledge of MS Office / computer software programs / applications preferred
o Strong written and verbal communication skills
o Excellent organizational and time management skills
o Pro-active personality with demonstrated sense of urgency, eye for anticipation and continuous improvement
o Ability to work while gowned with personal protective equipment.
o Ability to periodically lift up to 80 lbs. when required in support of operations
Education & Experience:
o HS Diploma or Trade Certificate with 5 years relevant experience; Associates Degree with 3 years relevant experience; or, Bachelor s Degree with of 1-2 years relevant work experience required. Relevant experience in a regulated pharmaceutical / manufacturing / warehousing / supply chain environment or equivalent discipline.
o Relevant experience in cGMP Processes, Facilities and Operations preferred.
o Hands-on experience, strong technical and mechanical aptitude skills required.
o Department of Transportation certification preferred (DOT)
o International Air Transportation Certification preferred (IATA)
o Knowledge of Resource Conservation and Recovery Act (RCRA) waste handling, inspection and documentation preferred.
o Proficient with computer software programs / applications; and capable of preparing technical reports as required.
o Demonstrates an initiative for advancement within department / organization.
o Ability to work on project teams in support of department related initiatives.
o An equivalent combination of education, experience and training may substitute.
o Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
o Physical dexterity sufficient to perform required tasks
o Sufficient vision and hearing capability to work in job environment.
o Ability to use computers and / or manually record documentation
o Ability to competently operate warehouse machinery and basic hand tools
o Must have the ability to work around laboratories and controlled, enclosed, restricted process areas, cold rooms, solvent storage rooms, etc.
o Ability to wear additional over-garments and personal protective equipment when required in designated areas; e.g. lab coat, hair cover, shoe covers, gloves, respiratory protection.