2nd Shift Production Lead

Sharp Services, LLC; Bethlehem (Northampton County); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a 2nd Shift Production Lead to oversee clinical packaging operations. In this role, you will execute and manage all phases of packaging, labeling, and assembly of investigational drug products. Your leadership will ensure compliance with company SOPs and cGMP regulations while training and supervising a team of Packaging Technicians. This is a great opportunity to make a significant impact in a dynamic environment where your skills in communication and supervision will be highly valued. Join a team dedicated to excellence in clinical supply packaging and contribute to the success of innovative healthcare solutions.

Qualifications

• 1+ years of experience in clinical supplies packaging or cGMP.
• Excellent communication and supervisory skills are essential.

Responsibilities

• Oversee packaging of clinical supplies following approved instructions.
• Train and monitor Packaging Technicians to ensure compliance.

Skills

Communication Skills

Supervisory Skills

Problem-Solving

Time Management

Education

High School Diploma or GED

Tools

Packaging Equipment

Job description

2nd Shift Production Lead

Apply locations Bethlehem time type Full time posted on Posted 3 Days Ago job requisition id JR30987

The Production 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 (MIs), company SOPs and cGMP Regulations.

Responsibilities:

1. Execute packaging of clinical supplies as determined by the approved manufacturing instructions (MIs) in accordance with company SOPs and cGMP Regulations.
2. Complete support documentation associated with the execution of the packaging operation(s) being performed.
3. Ensure that packaging areas are maintained in accordance with company SOPs and cGMP Regulations before, during, and after any packaging operation.
4. Able to operate packaging equipment.
5. Train Packaging Technicians on job specific duties.
6. Monitor Packaging Technicians in assigned packaging area to ensure compliance with company SOPs, manufacturing instructions (MIs), and cGMP Regulations.
7. Adhere to set safety standards.
8. Achieve expected performance measures.

Qualifications:

1. High School diploma or general education degree (GED) equivalent.
2. 1+ years of previous packaging of clinical supplies or cGMP experience required.
3. Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
4. Demonstrated ability to monitor and supervise packaging operations.
5. Demonstrate the ability to lead as a change agent, handle multiple tasks simultaneously, and negotiate and meet critical timelines.
6. Responsible for cleaning of cGMP packaging areas, equipment and utensils on an as needed basis.