Production Room Leader 1st Shift

Sharp Clinical Services, Inc.; Town of Bethlehem (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Packaging Services seeks a Clinical Supplies Room Leader to oversee packaging, labeling, manufacturing and assembly of investigational drug products in line with MI’s, SOPs, and cGMP.

The role includes training Packaging Technicians, monitoring operations for compliance, and ensuring safety and timely delivery. Strong leadership and communication are required.

Qualifications

• Demonstrated leadership and ability to supervise packaging operations.
• Strong knowledge of cGMP regulations and SOPs.
• Excellent oral and written communication with team and external contacts.

Responsibilities

• Execute packaging of clinical supplies per MI’s, SOPs, and cGMP regulations.
• Complete support documentation for packaging operations.
• Maintain packaging areas in compliance with SOPs and cGMP.

Skills

Leadership

cGMP knowledge

Communication skills

Supervision

Project coordination

Education

High School diploma or GED

Tools

Packaging equipment

Job description

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.

QUALIFICATIONS

To 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.

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.