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.

Job Summary:

Experienced Quality Assurance professional with comprehensive responsibilities for maintaining of the quality systems, including raw materials/packaging components release, batch records review, stability program and annual inspection, documentation system, training program, change control system, internal audit, regulatory inspection, supplier quality management, computerized system, regulatory intelligence, distribution management, investigation and CAPA system, product complaint, annual product review (APR) and annual report (AR), quality control alert limit (QCAL), cleaning validation (CV), Cross Contamination, aseptic operation, quality risk management (QRM) and quality improvement projects.

Responsibilities:

- Review incoming materials related documents, perform material sampling, purified water sampling, ID testing and complete material release activities.
- Printing Packaging Material Artwork Management
- Review batch records and related documents to confirm the information is complete, accurate, and valid for batch disposition.
- Responsible for stability program management, stability chamber management and reviewing RMS report of stability chambers/room.
- Responsible for reserve/reference/retention sample management and conduct the annual inspection program.
- 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.
- Ensure the compliance of equipment qualification and computer system validation procedure.
- 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
- Participate, facilitate and review investigations of deviation, laboratory investigations and product complaint. Propose, review and implement corrective and preventive actions to address the identified root cause(s). Review and approve the outcome of effective checks.
- Collect, compile, review annual product review document. Collect documents for customer annual report request(s).
- Develop, maintain and provide statistics support and consult of QCAL.
- Handle and/or coordinate quality risk management of the site for risks evaluations, controls and mitigation.
- Lead, coordinate, support and execute QIP for site innovation, improvement and enhancement of regulatory requirements.
- Manage cross contamination and cleaning validation program. Schedule related sampling activities.
- Issue and update tracking sheet for MBR/PBR and related documents and manage protocols which are under execution by QA team.
- OOSN control for equipment and production room
- Create and revise related SOPs and documents
- Support QA inspector daily activities as required.
- Other tasks as assigned by the company.

Qualification and Requirements:

- QA associate II:

- B.S. or higher degree in Science or Pharmaceutical Science. Under 3 year working in biotechnology or GMP pharmaceuticals field. Or equivalent combination of education and experience.

- Follows management’s direction to complete assigned tasks accurately and on time.

- Excellent communication and interpersonal skills to work with cross functional teams

- Requires strong computer skills in Microsoft Office (Excel, Power Point and Word)

- Great organizational and time management skills

- Fluent speaking and good writing skills in both English and Mandarin.

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.