Apollo Biological Technology Co., Ltd.

Apollo Biological Technology Co., Ltd.

QA Specialist (Temporary: 6–12 Months) Industry: Pharmaceutical | Employment Type: Full-Time, Temporary | Location: Remote (U.S.-Based, with Occasional Domestic and International Travel) About the Role We are seeking a motivated, detail-oriented Quality Assurance (QA) Specialist to join our team on a temporary basis for 6 to 12 months. In this role, you will play a key part in supporting the establishment and ongoing maintenance of a robust Quality Management System (QMS), ensuring that company procedures remain fully compliant with applicable regulatory frameworks including GMP, FDA, EMA, and ICH guidelines. This is a cross-functional position that offers meaningful exposure to regulated pharmaceutical operations, quality documentation, audit coordination, and continuous improvement initiatives. You will collaborate closely with internal teams as well as external partners such as CDMOs, CMOs, Regulatory Affairs, and Supply Chain stakeholders. Key Responsibilities Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) Review and approve quality documentation including SOPs, work instructions, batch records, and quality records to ensure accuracy and compliance Assist with document control activities to maintain alignment with established document management procedures and regulatory requirements Coordinate and participate in internal audits, and provide support during external customer audits, supplier audits, and regulatory inspections Assist in investigations related to nonconformances, deviations, and complaints, and support the development and tracking of Corrective and Preventive Actions (CAPAs) Support change control activities and participate in risk assessments associated with process or system changes Collaborate cross-functionally with CDMOs/CMOs, Regulatory Affairs, Supply Chain, and other external stakeholders to uphold quality standards across the product lifecycle Contribute to quality metrics reporting and support the preparation of management review materials as needed Help identify opportunities for process optimization and participate in continuous improvement projects Requirements Bachelor's degree or above in Life Sciences, Engineering, Quality Management, or a related technical discipline 2+ years of Quality Assurance experience in a regulated industry; experience in pharmaceuticals, biotechnology, medical devices, food manufacturing, or a related field is strongly preferred Demonstrated experience with CAPA management, internal and external audits, document control, and change management processes Solid understanding of GMP, FDA, EMA, and ICH regulatory requirements Strong attention to detail with excellent organizational and analytical problem-solving skills Effective written and verbal communication skills, with the ability to clearly convey quality-related information to both technical and non-technical audiences Proficiency in Microsoft Office Suite; experience with an electronic Quality Management System (eQMS) is highly desirable Proven ability to manage multiple priorities simultaneously and work independently in a fast-paced, deadline-driven environment Language Requirements Fluent English communication skills (written and verbal) are required Proficiency in Chinese (Mandarin) or other additional languages is considered a meaningful advantage What We Offer A competitive salary and attractive compensation package The opportunity to contribute to innovative pharmaceutical projects within a quality-focused, collaborative team environment Meaningful hands-on experience in a regulated industry with exposure to real-world quality systems and processes Broad exposure to cross-functional quality initiatives, audit programs, and continuous improvement projects A dynamic remote work environment with flexibility, supported by a team committed to quality excellence