Operations Technician

Motion Recruitment; Rahway (NJ); Vor Ort; USD 40.000 - 60.000; Vollzeit

Zusammenfassung

Kelly Science and Clinical FSP in Rahway, NJ is seeking an Operations Technician I for a long-term engagement with a Global Pharmaceutical client. The role is full-time and offers full benefit options.

As part of the Kelly FSP division, you will help maintain cGMP practices, perform packaging and distribution tasks, and ensure accurate documentation while collaborating with cross-functional teams. On-site training and benefits are included.

Qualifikationen

• Bachelor’s degree preferred; relevant experience may be considered.
• 0-3 years experience; without a degree, 3+ years recommended.
• Experience with respiratory equipment; GMP principles; packaging knowledge; SAP desirable.

Aufgaben

• Maintain cGMP and safety training to site requirements.
• Follow cGMP, SOPs and safety requirements in all activities.
• Operation in cold vaults, walk in CTUs, and stand up CTUs.
• Execute assigned technical tasks and follow up on their completion.
• Collaborate with team members to ensure operational efficiency.
• Maintain accurate documentation related to technical activities.
• Performs Packaging, Warehousing, and Distribution activities according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies.
• Primary and secondary packaging of drug products, and secondary packaging of biologics and vaccines.
• Distribution activities, such as order processing, drug picking/packing/shipping.
• Performs all tasks related to clinical label printing production.
• Warehousing activities, such as bulk and component inventory movement and accuracy.
• Manage the ordering and inventory levels for consumables.
• Supports Quality oversight to the Operations area through the following:

Kenntnisse

Organizational skills

Detail-oriented

Equipment operation

Troubleshooting

Problem-solving

Learn new systems

GMP knowledge

Ausbildung

Bachelor’s degree preferred

Experience 0-3 years

Tools

SAP

Jobbeschreibung

Kelly Science and Clinical FSP is currently seeking a Operations Technician I for a long-term engagement in Rahway, NJ with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Key Responsibilities

• Maintain cGMP and safety training to site requirements.


• Follow cGMP, Standard operating procedures and safety requirements in all activities.


• Operation in cold vaults, walk in CTUs, and stand up CTUs.


• Execute assigned technical tasks and follow up on their completion.


• Collaborate with team members to ensure operational efficiency.


• Maintain accurate documentation related to technical activities.


• Performs Packaging, Warehousing, and Distribution activities according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies.


• Primary and secondary packaging of drug products, and secondary packaging of biologics and vaccines.


• Distribution activities, such as order processing, drug picking/packing/shipping.


• Performs all tasks related to clinical label printing production.


• Warehousing activities, such as bulk and component inventory movement and accuracy.


• Manage the ordering and inventory levels for consumables.


• Supports Quality oversight to the Operations area through the following:
  
  
  
  • o Authoring or revising SOP’s.
  
  
  • o Supporting batch record reconciliation / review activities.
  
  
  • o Supporting investigations with a focus on true root cause, and creation of appropriate corrective and preventative actions (CAPAs).
  
  
  • o Participate as subject matter expert during internal or external audit from Quality group, safety bodies or regulatory agencies.
  
  
  
  


• Supports creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles. May liaise with other functions in Global Clinical Supply (GCS) or other partner groups.


• Undertake specific projects within the group on as needed basis.


• Ability to repetitively lift, carry, push and pull up to 50 lbs. required for Packaging and Warehouse roles.


• Training on forklift and pallet jack use.


• Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to GMP environment and area-specific tasks.

Qualifications

• Bachelor’s degree preferred; candidates with relevant experience may be considered.


• 0-3 years of experience in a related field; candidates without a degree should have 3+ years of relevant experience.


• Experience using/wearing respiratory equipment


• Understanding of Good Manufacturing Practice (GMP) principles.


• Knowledge of quality and safety requirements for pharmaceutical packaging / handling.


• SAP experience is highly desired.

General Skills

• Strong organizational and detail-oriented skills.


• Equipment operation and repair skills.


• Problem-solving and troubleshooting abilities.


• Ability to quickly learn new systems required.


• Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to GMP environment and area-specific tasks.