Room Leader 2nd shift

Sharp Services; Bethlehem (Northampton County); On-site; USD 45,000 - 60,000; Full time

Job summary

Sharp Services is seeking a Clinical Supplies Room Leader in Bethlehem, United States. This role entails overseeing all phases of clinical packaging, ensuring compliance with company SOPs and cGMP regulations.

The ideal candidate will supervise packaging operations, train staff, and maintain safety standards while executing essential duties in conjunction with approved manufacturing instructions. A high school diploma and a year's experience in clinical supplies packaging is required.

Qualifications

• 1+ years of previous clinical supplies packaging or cGMP experience required.
• Ability to supervise packaging operations effectively.
• Responsible for maintaining cGMP compliance.

Responsibilities

• Execute packaging of clinical supplies according to MI's.
• Train and monitor Clinical Supplies Packaging Technicians.
• Ensure compliance with company SOP's and safety standards.

Skills

Communication skills

Supervision

Multi-tasking

Education

High School diploma or GED

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.