Assistant Technician, Inspection & Packaging-2nd Shift

Bora Pharmaceuticals Injectables Inc; Baltimore (MD); Sur place; USD 21 000 - 30 000; Plein temps

Résumé du poste

Bora Pharmaceuticals Injectables Inc is seeking an Inspector/Packaging Operator for the 2nd shift (2:00 PM–10:30 PM) with a 10% shift differential. The role focuses on inspection, labeling, cartoning, serialization, and ensuring adherence to cGMP standards while supporting day-to-day operations.

Responsibilities include documenting steps, ensuring accuracy of lot data, and maintaining environmental controls. A HS diploma and at least 1 year of relevant experience are required.

Qualifications

• 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.

Responsabilités

• Demonstrate competency on assigned qualification blocks.
• Execute and document procedural steps in compliance with cGMP standards.
• Operate labeling, cartoning, and serialization machines with supervision.
• Review documentation for accuracy and data integrity.
• Monitor chart recorders for temperature-controlled areas and participate in weekly rotation.

Connaissances

Independent work

Process decisions

cGMP & CFR knowledge

Formation

HS Diploma or equivalent

Description du poste

About

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.

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

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.

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.