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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.

Job 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.

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.

Inspection Path

• Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)
• Successfully complete annual inspector re-qualification requirements and ensure their qualification does not expire.
• Execute Sampling Inspection, Sampling Labeling and Packaging, Sampling Delivery and 100% visual inspection and complete the required documentation in the batch record and associated logbooks.
• Operate the Tray Vision according to the standard operating procedure.
• Be able to change, monitor and retrieved temperature data from the chart recorders.
• Will identify and champion process improvement initiatives.
• Basic troubleshooting of inspection issues.

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 Salary Range: 40,000 - 60,000

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 off

• Professional development opportunities

• Employee wellness programs and resources

• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.