Supervisor Production
Bora Pharmaceuticals
Summary
The Production Supervisor will be responsible for execution of production fill activities associated with a RABS (Restricted Access Barriers System) fill line, including development of procedures and subsequent training of operators, supporting execution of qualification activities, and ensuring compliance with safety standards and established policies and procedures.
Job description
Essential Functions
- Monitor and ensure compliance by all personnel with cGMP regulations, Company policies, and SOP and Batch Record directions. Maintain a high degree of visibility and access to employees throughout the shift.
- Responsible for development of procedures and batch records associated with equipment preparation operations and subsequent training of operators.
- Provide technical expertise and support for execution of qualification activities.
- Review documentation, including executed batch records, and ensure that it complies with Good Documentation Practices.
- Coordinate, schedule, and oversee Equipment Preparation activities.
- Interface with the Quality Assurance; Facilities and Maintenance; Materials Management; and Manufacturing, Science, and Technology departments to resolve production, supply, and equipment issues. Document issues through deviations and assist with investigations, as necessary.
- Basic understanding and operation of vial washers, autoclaves, and depyrogenation ovens; basic understanding of manual cleaning of equipment in a pharmaceutical environment
- Author & Implement CAPAs, Deviations, and Change Controls
Minimum Education, Experience and Skills
- BA/BS in science or technical field with minimum of 3 years' experience in cGMP or regulated environment.
- Or High School/AA with a minimum of 8 years' experience in cGMP environment.
- 3 years previous supervisory experience in cGMP environment preferred.
Skills
- Good written and oral communication skills.
- The ability to lead a group including motivating and inspiring the team.
- Strong problem-solving skills as well as the ability to provide and accept feedback.
- The ability to identify and resolve issues in a timely manner.
- Willingness to make decisions and apply proper judgment based on sound, accurate information.
- Flexibility and the ability to maintain effectiveness when experiencing major changes in work schedule and priorities.
- The ability to handle multiple tasks and projects at the same time, and good time management.
Requirements
- BA/BS in science or technical field with minimum of 3 years' experience in cGMP or regulated environment.
- Or High School/AA with a minimum of 8 years' experience in cGMP environment.
- 3 years previous supervisory experience in cGMP environment preferred.
- Good written and oral communication skills.
- The ability to lead a group including motivating and inspiring the team.
- Strong problem-solving skills as well as the ability to provide and accept feedback.
- The ability to identify and resolve issues in a timely manner.
- Willingness to make decisions and apply proper judgment based on sound, accurate information.
- Flexibility and the ability to maintain effectiveness when experiencing major changes in work schedule and priorities.
- The ability to handle multiple tasks and projects at the same time, and good time management.
Benefits
- Competitive salary
- Performance-based incentives
- Medical, Dental & Vision
- Retirement savings plans
- Employer matching contributions
- Paid time off
- Professional development opportunities
- Employee wellness programs
- Employee Assistance Program
- Mental Health Resources
Company overview
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) headquartered in Taipei, Taiwan, with a global presence across North America and Asia. Founded in 2007 by Bobby Sheng, the company operates ten state-of-the-art CGMP manufacturing facilities strategically located to serve over 100 markets worldwide. Bora specializes in comprehensive pharmaceutical development and manufacturing solutions for a wide range of dosage forms including oral solid dose, liquids, semi-solids, ophthalmics, biologics, and sterile injectables. The company employs a distinctive dual-engine strategy that combines scalable CDMO services with innovative drug development focused on specialty pharmaceuticals and rare diseases. With a workforce of 1,001-5,000 employees, Bora provides end-to-end services from early phase clinical development through commercial manufacturing, supported by full packaging capabilities. The company is publicly traded on the Taiwan Stock Exchange (TWSE: 6472) and has established itself as a trusted partner for biopharmaceutical companies globally through its commitment to quality, operational excellence, and strategic growth initiatives.