Quality Assurance Specialist

It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity n us, and let’s transform lives, together.

Pharma Essentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung.

The Quality Assurance Specialist reports to the senior manager of QA and will play a key role in managing the product quality system, including product release batch records review, deviation/CAPA, product quality complaints, recall and ensuring DSCSA (Drug Supply Chain Security Act) compliance together with supporting QA activities, such as supplier audits and authority inspections.

The key responsibilities of the position include, but are not limited to, the following:

• Manage assigned QMS processes, including change control, deviations, investigations, corrective and preventive actions (CAPA), and quality risk management.
• Monitor quality records and follow up with process owners to support timely completion and effective closure.
• Prepare quality metrics, summaries, and trend reports for management review and continuous improvement.

• Collaborate with cross functional units including the call center, external partners, internal teams, and headquarters to manage product quality complaints in alignment with SOPs and regulatory requirements
• Ensure timely response and communication to resolve return/ replacement request arise from Product Quality Complaints
• Coordinate investigations with internal stakeholders and third-party vendors, ensuring root cause analysis and corrective actions are implemented.
• Complete and retain proper documentation of complaint details.
• Prepare complaint summaries and trend reports for management review.

• Oversee compliance with DSCSA serialization and product tracing requirements.
• Validate serialization systems and ensure data integrity across the supply chain.
• Coordinate investigations of suspect or illegitimate products, product defects, and DSCSA exceptions.
• Support product recalls or withdrawals, including communication with trading partners and regulatory authorities.
• Ensure timely submission of notifications to FDA as required by DSCSA policy.

• Review batch records related to GDP (Good Distribution Practice) to support product release schedule, ensuring regulatory compliance, and delivery of products.
• Identify and resolve all GDP records discrepancies to prevent a regulatory impact.
• Collaborate with HQ QA to ensure an efficient and compliance process for product release.
• Ability to exercise independent judgement and critical thinking.

• Maintain effective communication with stakeholders to ensure compliance and timely resolution of quality issues.
• Lead assigned quality projects and coordinate activities across internal and external stakeholders.
• Participate in…