Production Room Leader 1st Shift

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 42,000 - 54,000; Full time

Job summary

Sharp Clinical Services in Bethlehem, PA seeks a Packaging Technician to execute clinical supplies packaging in accordance with MI’s and cGMP regulations. You will operate packaging equipment, maintain clean areas, and complete related documentation.

You will train and supervise Packaging Technicians, monitor adherence to SOPs, MI’s, and safety standards, and participate in regular meetings to achieve performance goals. This role requires high school diploma and 1+ year packaging experience.

Qualifications

• High School diploma or 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.

Responsibilities

• Execute packaging of clinical supplies as determined by the approved MI’s in accordance with SOPs and cGMP Regulations.
• Complete support documentation associated with the execution of the packaging operation(s).
• Ensure that packaging areas are maintained in accordance with SOPs 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 SOP’s, MI’s, and cGMP Regulations.
• Adhere to set safety standards.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Other duties as assigned.

Skills

Communication skills

Supervision

Change agent

Multitasking

Safety compliance

Education

High school diploma or GED

Job description

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.

QUALIFICATIONS

• 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.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.