Manufacturing Group Lead- Preparation (2nd Shift)

Simtra BioPharma Solutions•Bloomington, IN

15h•Onsite

About The Position

The Prep Group Lead is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Preparation Operators who perform in the manufacturing areas. The Prep Group Lead provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. Schedule: Monday-Thursday, 2:00pm to 12:30am

Requirements

High school diploma or GED required
6 months of previous Pharmaceutical or Manufacturing experience preferred
Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.
Final candidates for Preparation Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

Nice To Haves

Ability to work independently
Good communication skills
Good documentation skills, including legible handwriting
Good interpersonal skills
Basic computer skills
Basic math skills
Knowledge of aseptic manufacturing practices
Knowledge of standard operating procedures, specifications, and job-specific training materials
Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Responsibilities

Understand and follow current Good Manufacturing Practices
Assemble and operate filtration systems
Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc)
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
Write, revise and review pertinent documentation as appropriate
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion.
Required to maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required