GMP Production Supervisor - Lead Equipment Prep

Bora Pharmaceuticals; Baltimore (MD); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Health coverage

Retirement plans

Paid time off

Professional development opportunities

Wellness programs

Job summary

Bora Pharmaceuticals in Baltimore is seeking a Production Supervisor to oversee fill line activities, develop procedures, train operators, support qualification activities, and ensure compliance with safety standards and established policies.

You will coordinate Equipment Preparation, review batch records for Good Documentation Practices, and collaborate with Quality Assurance, Facilities, Materials Management, and Manufacturing to resolve production issues.

Qualifications

• BA/BS in science or technical field with minimum of 3 years' experience in cGMP or regulated environment.
• High School/AA with a minimum of 8 years' experience in cGMP environment.
• 3 years previous supervisory experience in cGMP environment preferred.

Responsibilities

• Monitor and ensure cGMP compliance by personnel.
• Maintain visibility and access to employees during shift.
• Develop procedures and batch records for equipment preparation and train operators.
• Provide technical support for qualification activities.
• Review batch records for compliance with Good Documentation Practices.
• Coordinate equipment preparation activities and scheduling.
• Interface with QA, Facilities, Materials, and Manufacturing to resolve production issues.
• Understand vial washers, autoclaves, depyrogenation ovens and cleaning of equipment.

Skills

Communication

Leadership

Problem solving

Decision making

Time management

Adaptability

Education

BA/BS in science or technical field

High School/AA with 8 years cGMP experience

3 years supervisory experience in cGMP environment

Job description

Bora Pharmaceuticals in Baltimore is seeking a Production Supervisor to oversee fill line activities, develop procedures, train operators, support qualification activities, and ensure compliance with safety standards and established policies.

You will coordinate Equipment Preparation, review batch records for Good Documentation Practices, and collaborate with Quality Assurance, Facilities, Materials Management, and Manufacturing to resolve production issues.