Production Room Leader 2nd Shift

Sharp Services, LLC; Bethlehem (Northampton County); On-site; USD 52,000 - 75,000; Full time

Benefits offered by this job

Health and safety program

Job summary

Sharp Packaging Services in Bethlehem is seeking a Production Room Leader for the 2nd shift to oversee the packaging, labeling, and assembly of investigational drug products. You will ensure that manufacturing instructions and cGMP requirements are followed, while guiding the packaging team to meet tight timelines.

You will train Packaging Technicians, monitor operations for quality and safety, and complete essential documentation.

Qualifications

• High School diploma or GED equivalent.
• 1+ years of clinical supplies packaging or cGMP experience.
• Excellent oral and written communication skills.
• Demonstrated ability to supervise packaging operations.
• Ability to lead as change agent and manage multiple tasks to meet timelines.

Responsibilities

• Execute packaging of clinical supplies per MI’s in accordance with SOPs and cGMP.
• Complete support documentation for packaging operations.
• Maintain packaging areas per SOPs and cGMP regulations before, during, and after operations.
• Operate packaging equipment.
• Train Clinical Supplies Packaging Technicians on job duties.
• Monitor Packaging Technicians for compliance with SOPs and MI’s.
• Adhere to set safety standards and participate in meetings.
• Achieve expected performance measures.
• Other duties as assigned.

Skills

Leadership

Supervision

Communication

Time management

Education

High School diploma or GED

Job description

Production Room Leader 2nd Shift# Sharp Packaging Services## Production Room Leader 2nd ShiftApply: Bethlehem: Full time: Posted Yesterday: JR32653**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.