Production Room Lead

RxSource Limited; New Jersey; On-site; USD 65,000 - 90,000; Full time

Job summary

RxSource Limited in New Jersey seeks a Production Room Lead to oversee packaging operations, enforce cGMP, and ensure quality across secondary packaging runs, labeling, and calendar management.

The role requires experience in label applications and temperature-controlled environments, strong data integrity, and ability to coordinate with warehouse teams while driving continuous improvement and client service.

Qualifications

• Minimum 3 years of experience in GMP production.
• Minimum 1 year in room lead role.
• Experience with Good Documentation Practices required.
• Experience in different types of label applications at multiple temperature ranges preferred.
• Willing to package and label in 2-8C and -20C with PPE.

Responsibilities

• Participate and lead secondary packaging runs.
• Ensure packaging runs are completed to the highest quality.
• Set expectations for Production Associates and enforce compliancy with RxSource Procedures and cGMP.
• Work cross functionally with Warehouse Operations team for resource allocation.
• Report any staff issues or capacity conditions to Operations Supervisor or above.
• Update and maintain production calendar for assigned site.
• Perform transactions in 1Source postproduction.
• Develop and maintain cleaning schedule of all rooms.
• Ensure all health and safety guidelines are enforced and maintained.
• Continuous improvement in the secondary packaging and labeling environment.
• Provide updates on packaging runs, completion, and challenges.
• Participate in warehousing activities if there is lower volume in packaging and labeling.
• KPI tracking and reporting of packaging and labeling metrics as per Leadership and client specifications.
• Other duties as assigned.

Skills

GMP production

Leadership

Documentation integrity

Tools

ERP platforms

Job description

At RxSource, our passion is to improve the lives of patients. As a global provider of clinical trial supply services, we support pharmaceutical and biotech partners for clinical trial supply projects by delivering industry leading timelines with our flexible capacity planning and a dedication to achieve the extraordinary. With operations in Canada, the USA, and Ireland, our portfolio of services include; sourcing of commercial products (comparator, co-medications, rescue medications, ancillaries), packaging, labelling and distribution of clinical trial supplies within temperature-controlled conditions through our facilities.

Our team and culture are our greatest strengths-driven by our core values, a can-do attitude, and deep expertise. This is what sets us apart. When you partner with us, your trial is our passion.

Position Summary:

The Production Room Lead will report to the Operations Supervisor and will be actively involved in developing, implementing, and enforcing policies that ensure the safety and efficiency of production. The successful candidate will have experience in different types of label application (single panel, booklet, flag, etc.), application at multiple temperature ranges, including frozen, ultra frozen, and refrigerated, management and data integrity of blinded production activities, and lead experience. The selected candidate will have a strong focus on client service, delivery, reliability, and leading by example. This candidate should have at least 3 years of experience in GMP warehouse environment and secondary packaging and labeling, can quickly switch gears to handle a range of duties and is proficient with ERP platforms

Responsibilities:

• Participate and lead secondary packaging runs.
• Ensure packaging runs are completed to the highest quality.
• Set expectations for Production Associates and enforce compliancy with RxSource Procedures and cGMP.
• Work cross functionally with Warehouse Operations team for resource allocation
• Report any staff issues or capacity conditions to Operations Supervisor or above.
• Update and maintain production calendar for assigned site.
• Perform transactions in 1Source postproduction.
• Develop and maintain cleaning schedule of all rooms.
• Ensure all health and safety guidelines are enforced and maintained.
• Constant focus on continuous improvement in the secondary packaging and labelling environment.
• Participate and provide updates on a regular basis of packaging runs, completion, and challenges.
• Participate in warehousing activities if there is lower volume in packaging and labelling.
• KPI tracking and reporting of packaging and labelling metrics as per Leadership and client specifications, where applicable.
• Other duties as assigned.

Qualifications:

• At least three years of experience in GMP production
• At least one year of experience in room lead role
• Experience in Good Documentation Practices required
• Experience in different types of label applications at multiple temperature ranges preferred
• Must be willing to Package and Label in 2-8C and -20C conditions with appropriate Personal Protective Equipment (PPE)

No matter your role at RxSource, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Achievers, who drive toward practical solutions
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality and accountable executors, working towards goals and milestones with quality, precision, and speed