About Bora
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.
From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.
At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.
Summary
This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day-to-day operations. This position will support our 2nd-Shift operations, working 2pm-10:30pm, Monday - Friday. 10% shift differential.
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
General Responsibilities
Demonstrate competency on assigned qualification blocks: Job specific Standard Operating Procedures
Annual Inspector Re-qualification
Execute and document procedural steps in compliance with cGMP standards.
Perform room clearances in accordance with relevant Standard Operating Procedures
Adhere to the procedures and safe practices for movement of product and materials and accurately complete all applicable documentation. This applies to room temperature and cold storage locations.
Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures
Review all documentation generated as each step is completed for accuracy of calculations / data entry and completeness of process signature steps
Monitor chart recorders for temperature-controlled areas and participate in weekly rotation.
Packaging Path
Manually package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
Must be skills assessed on operation of the labeling machine. Able to operate the machine independently and with minimal supervision.
Must be skills assessed on operation of the cartoning machine. Able to load, unload and operate the cartoner during the cartoning process independently and with minimal supervision.
Must be skills assessed on operation of the serialization and aggregation machines. Able to load, unload and operate the serialization and aggregation equipment with minimal supervision.
Will identify and champion process improvement initiatives.
Basic troubleshooting of line issues.
Training and education may be conducted using virtual reality/artificial intelligence.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
Minimum Education, Experience and Skills
HS Diploma or equivalent
Minimum 1 year of relevant experience
Able to work independently with limited supervision
Must be knowledgeable to make process-related decisions
Knowledge of cGMP and CFR requirements
Annual Base Salary Range: 40000 - 60000
Compensation and Benefits
We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:
Competitive salary and performance-based incentives
Comprehensive health coverage including medical, dental, and vision insurance
Retirement savings plans with employer matching contributions
Paid time…