Production Room Leader 2nd Shift

Sharp Services•Bethlehem, PA

About The Position

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. This includes activities such as blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. The role prepares and completes packaging supplies and required documentation in accordance with approved manufacturing instructions (MIs), company SOPs, and cGMP regulations. The position also trains and monitors Clinical Supplies Packaging Technicians, ensures packaging areas meet applicable standards, operates packaging equipment, and is responsible for cleaning cGMP packaging areas, equipment, and utensils as needed.

Requirements

High school diploma or GED equivalent.
At least 1 year of previous clinical supplies packaging or cGMP experience.
Excellent oral and written communication skills for communicating with the team, peers, management, and external contacts.
Demonstrated ability to monitor and supervise packaging operations.
Ability to lead as a change agent, handle multiple tasks simultaneously, and negotiate and meet critical timelines.

Responsibilities

Execute clinical supplies packaging according to approved manufacturing instructions, company SOPs, and cGMP regulations.
Complete supporting documentation associated with packaging operations.
Ensure packaging areas are maintained according to company SOPs and cGMP regulations before, during, and after packaging operations.
Operate packaging equipment.
Train Clinical Supplies Packaging Technicians on job-specific duties.
Monitor technicians in assigned packaging areas to ensure compliance with company SOPs, manufacturing instructions, and cGMP regulations.
Adhere to safety standards.
Participate actively in regular meetings.
Achieve expected performance measures.
Clean cGMP packaging areas, equipment, and utensils as needed.
Perform other duties as assigned.