Finishing Ops Supervisor — Lean, cGMP Leader

Simtrabps; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 6%

Paid Time Off

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Supervisor for the Finishing production area. You will lead a team, ensure safe and efficient production in full cGMP adherence, and drive continuous improvement on the shop floor.

The role emphasizes hands-on leadership, strong communication, and a commitment to safety, quality, and patient outcomes. You will interact with multiple levels of management and support departments to meet production goals.

Qualifications

• High School diploma or GED required.
• Minimum 2 years of manufacturing experience required.
• Minimum 1 year leadership experience required.
• In-depth process knowledge of related manufacturing equipment and processes preferred.
• Experienced understanding of cGMPs and other regulatory guidelines preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook; ability to use enterprise software like Veeva/Trackwise/SCADA.

Responsibilities

• Understand and follow current Good Manufacturing Practices (cGMP).
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff; conduct annual performance reviews; set objectives and development plans.
• Supervise day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities to meet customer requirements and deadlines.
• Review, approve, and manage documentation for batch and system records; assist in release of product for distribution; assist in meeting release time goals.
• Implement and support training programs to ensure staff carry out manufacturing processes with strict cGMP and EHS compliance.
• Develop and implement performance measurement and internal auditing programs; implement changes based on assessments.
• Lead technical reviews, investigations and process improvements; provide input into integration/validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact deadlines; provide guidance during deviations using RCA tools.
• Represent the company during audits and inspections; author NCRs when needed.

Skills

LEAN manufacturing

cGMP

Leadership

Communication

Safety awareness

Training & development

Education

High School diploma or GED

Tools

Veeva

Trackwise

SCADA

MS Office

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Supervisor for the Finishing production area. You will lead a team, ensure safe and efficient production in full cGMP adherence, and drive continuous improvement on the shop floor.

The role emphasizes hands-on leadership, strong communication, and a commitment to safety, quality, and patient outcomes. You will interact with multiple levels of management and support departments to meet production goals.