Production Room Leader 1st Shift

Sharp Services, LLC; Bethlehem (Northampton County); On-site; USD 52,000 - 68,000; Full time

Job summary

Sharp Packaging Services in Bethlehem, PA seeks a Production Room Leader to oversee clinical supplies packaging, labeling, and assembly in a fast-paced GMP environment. You will supervise Packaging Technicians and ensure MI’s compliance while upholding safety standards.

The role requires strong communication, the ability to manage multiple tasks, and leadership to drive continuous improvement. Training and mentoring are part of daily duties as you maintain quality and efficiency in manufacturing

Qualifications

• 1+ years of clinical supplies packaging or cGMP experience.
• Excellent oral and written communication skills.
• Demonstrated ability to monitor and supervise packaging operations.
• Ability to lead as a change agent, handle multiple tasks, and meet timelines.
• Responsible for cleaning of packaging areas, equipment and utensils as needed.

Responsibilities

• Execute packaging of clinical supplies per MI’s and cGMP regulations.
• Complete support documentation for packaging operations.
• Ensure packaging areas are maintained per SOPs and cGMP regulations.
• Able to operate packaging equipment.
• Train Packaging Technicians on job duties.
• Monitor Packaging Technicians for compliance and safety.
• Participate in regular meetings and achieve performance measures.
• Other duties as assigned.

Skills

Communication skills

Supervision

Leadership

Multi-tasking

Education

High School diploma or GED

Tools

Packaging equipment

Job description

Production Room Leader 1st Shift# Sharp Packaging Services## Production Room Leader 1st ShiftApply: Bethlehem: Full time: Posted Yesterday: JR32654**Job Description**The Clinical Supplies Room Leader, acting under direct supervision, executes and oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. He/She prepares and completes packaging supplies and required documentation in accordance with approved manufacturing instructions (MI’s), company SOP’s and cGMP Regulations. **ESSENTIAL DUTIES AND RESPONSIBILITIES*** Execute packaging of clinical supplies as determined by the approved manufacturing instructions (MI’s) in accordance with company SOP’s and cGMP Regulations.* Complete support documentation associated with the execution of the packaging operation(s) being performed.* Ensure that packaging areas are maintained in accordance with company SOP’s and cGMP Regulations before, during, and after any packaging operation.* Able to operate packaging equipment.* Train Clinical Supplies Packaging Technicians on job specific duties.* Monitor Clinical Supplies Packaging Technicians in assigned packaging area to ensure compliance with company SOP’s, manufacturing instructions (MI’s), and cGMP Regulations.* Adhere to set safety standards.* Participate actively in regular meetings.* Achieve expected performance measures.* Other duties as assigned.QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.* High School diploma or general education degree (GED) equivalent* 1+ years of previous clinical supplies packaging or cGMP experience required.* Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.* Demonstrated ability to monitor and supervise packaging operations.* Demonstrate the ability to lead as a change agent, handle multiple tasks simultaneously, and negotiate and meet critical timelines.* Responsible for cleaning of cGMP packaging areas, equipment and utensils on an as needed basis.