Technician, Operations (Onsite)

MSD•Rahway, NJ

10h•Onsite

About The Position

Working closely with Senior Packaging Technicians, work within a team environment to execute clinical packaging and labeling activities, including material, room and equipment staging, execution and documentation of operations, and room clearance and cleaning. Perform visual inspection of rooms and equipment post-cleaning. Provide hands-on training for new employees. Support additional operational activities in support of sampling and material transfer. Performs all tasks related to clinical label printing production. Maintain training and compliance with site safety and quality requirements. This role is part of a shift, with specific requirements for start and stop times and requires onsite presence five days a week. General Responsibilities: Maintain cGMP and safety training to site requirements. Follow cGMP, Standard Operating Procedure (SOP) and safety requirements in all activities. Report potential quality events, non-conformance to GMPs/SOPs when observed. Ensure all paperwork is properly executed using Good Documentation Practices Occasional overtime and weekend work may be requested. Interact with employees within own department as well as frequent interactions with employees from other groups/departments. Support investigations and internal inspections. Supports creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles. Undertake specific projects within the group on as needed basis. Warehouse-specific Responsibilities: Perform incoming material receipt, clinical site drug returns and sample management. Receive, inspect and store all warehouse inventory. Execute sample collection activities. Perform inventory functions such as weekly replenishment, posting of Excess & Obsolete inventory and min/max changes. Coordinate and execute discard process for, but not limited to, expired and non-available inventory. Process order management and material staging in support of packaging/labeling work centers. Emergency cold vault coverage, when needed. Perform regular cycle counts, ensuring system inventory accuracy. Manages shipping activities, freight and logistics functions (pick, pack, label, schedule, ship) May be assigned to coordinate and/or prioritize warehouse activities. Manages distribution of bulk and finished good clinical materials. Documentation: Creation of Packaging documents according to SOPs. Ensures correct documentation of transactions within SAP. Documentation according to Good Documentation Practice (GDP) Guideline. Check of correct content of written Good Manufacturing Practice (GMP) documents.

Requirements

High School Diploma or equivalent required
Growth mindset
Team player
Desire to learn packaging operations.
Excellent interpersonal and communication skills.
Detail-oriented and organized
Ability to repetitively lift, carry, push and pull up to 50 lbs. required for Packaging and Warehouse roles.
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.
Experience with Microsoft applications (Word, Outlook)
SAP experience is highly desired
Cold Chain experience is highly desired
Accountability
Analytical Problem Solving
Biological Manufacturing
Cleanroom Gowning
Computer Literacy
GMP Operations
Good Manufacturing Practices (GMP)
Laboratory Processes
Machinery Operation
Manufacturing Quality Control
Mechanical Equipment Maintenance
Operations Management
Packaging Operations
Pharmaceutical Manufacturing
Production Scheduling
Shift Work
Standard Operating Procedure (SOP) Writing
Vaccine Production

Responsibilities

Execute clinical packaging and labeling activities, including material, room and equipment staging, execution and documentation of operations, and room clearance and cleaning.
Perform visual inspection of rooms and equipment post-cleaning.
Provide hands-on training for new employees.
Support additional operational activities in support of sampling and material transfer.
Performs all tasks related to clinical label printing production.
Maintain training and compliance with site safety and quality requirements.
Maintain cGMP and safety training to site requirements.
Follow cGMP, Standard Operating Procedure (SOP) and safety requirements in all activities.
Report potential quality events, non-conformance to GMPs/SOPs when observed.
Ensure all paperwork is properly executed using Good Documentation Practices
Support investigations and internal inspections.
Supports creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles.
Undertake specific projects within the group on as needed basis.
Perform incoming material receipt, clinical site drug returns and sample management.
Receive, inspect and store all warehouse inventory.
Execute sample collection activities.
Perform inventory functions such as weekly replenishment, posting of Excess & Obsolete inventory and min/max changes.
Coordinate and execute discard process for, but not limited to, expired and non-available inventory.
Process order management and material staging in support of packaging/labeling work centers.
Emergency cold vault coverage, when needed.
Perform regular cycle counts, ensuring system inventory accuracy.
Manages shipping activities, freight and logistics functions (pick, pack, label, schedule, ship)
May be assigned to coordinate and/or prioritize warehouse activities.
Manages distribution of bulk and finished good clinical materials.
Creation of Packaging documents according to SOPs.
Ensures correct documentation of transactions within SAP.
Documentation according to Good Documentation Practice (GDP) Guideline.
Check of correct content of written Good Manufacturing Practice (GMP) documents.