Sterile Operations Supervisor

The contents contained in this job description are the minimum requirements required to be met for the aforementioned position. Under the direction of the Sterile Operations Manager or designee, the Sterile Operations supervisor responsible for performing all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products. 

Key Responsibilities:

Ensure all aspects of floor operations are running in a smooth and efficient manner through proper planning of personnel, materials, and equipment availability in order to support continuous manufacturing operations.

Manage Aseptic Operators training plans making sure they are up to date, relevant, and applicable to their job function. Ensure of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

Ensure that current requirements to environment, safety and health issues are met with in their operational areas.

Engage all relevant stakeholder to facilitate systematic problem solving happens on the shop floor.

Education/Experience:

Required: HS Diploma/GED and 12+ years applicable experience 

Preferred: Bachelors of Science and 0-5 yrs applicable experience

Advanced computer skills proficiency 

Military service highly desirable

Demonstrated acuity to mechanical troubleshooting

Location 

Midwest

Consultant 

Andy Ellis