Quality Assurance Specialist

Quality Assurance SpecialistAbout PharmaEssentia: 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 at PharmaEssentia. Join us, and let's transform lives, together. PharmaEssentia 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.Position OverviewThe 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.Key ResponsibilitiesQuality Management SystemManage 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.Product Quality Complaints ManagementCollaborate 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 requirementsEnsure timely response and communication to resolve return/ replacement request arise from Product Quality ComplaintsCoordinate 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.DSCSA ComplianceOversee 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.Production OversightReview 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.Cross-function collaboration and Quality SupportMaintain 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 audits and inspections, providing documentation and responses as needed.Other QA-related duties as assigned by management.Qualifications and ExperienceBachelor's degree in life sciences, pharmacy, biotechnology, chemistry, or a related field; advanced degree preferred.Three or more years of Quality Assurance experience in the pharmaceutical or biotechnology industry, including experience in a GxP-regulated environment.Working knowledge of applicable FDA regulations, ICH guidelines, and relevant GCP, GMP, and GDP expectations.Working knowledge of DSCSA and global serialization standards (e.g., GS1, EPCIS).Experience with QMS processes, non-conformance investigations, CAPA, audits, and inspection readiness.Ability to communicate effectively, build collaborative relationships, and influence cross-functional stakeholders.Flexible schedule to maintain timelines, shifting priorities and accommodate occasional early/evening meetings with global teams.Key CompetenciesQuality and compliance mindsetCross-functional collaborationAccountability and attention to detailLocation and Work ArrangementThis position is based in Burlington, Massachusetts, and follows a hybrid work model requiring on-site presence three days per week.Salary and BenefitsThe expected salary range for this position based on greater Boston, MA location is $81,151 - 101,959. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law. Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:Comprehensive medical coverageDental and vision coverageGenerous paid time-off401(k) retirement plan with competitive company matchMedical & Dependent Care Flexible Spending AccountUp to $150 monthly cell phone reimbursementEmployee Assistance ProgramAt PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.