QA Associate II

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. [Essential Job Fuctiions] Ensure change control system is robust and routed in a timely manner. Maintains an effective document control system. Develop, coordinate, monitor and track the personnel training programs. Ensure compliance with CSV master plan and procedures, relevant regulatory guidance, customer requirements for the implementation of computer system. Plan, execute and follow up on internal audit program. Coordinate, accompany and follow up Regulatory Authorities GMP inspection, PAI for new product and Third Party Audits by Customers. Perform supplier qualification and maintenance. Manage the regulatory updates, implementation and compliance related procedures. Ensure Bora GDP procedures are established, followed and executed appropriately in compliance with Current Good Distribution Practices (cGDPs) Collect, monitor, and report the quality metrics for the oversight of quality system Collect, compile, review annual product review document. Collect documents for customer annual report request(s). Lead, coordinate, support and execute QIP for site innovation, improvement and enhancement of regulatory requirements. Create and revise related SOPs and documents. Other tasks as assigned by the company. Handle and/or coordinate quality risk management of the site for risks evaluations, controls and mitigations. Support QA inspector daily activities as required 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 contributions - Paid time off and flexible work arrangements - Professional development opportunities - Employee wellness programs and resources - Employee Assistance Program and Mental Health Resources 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.