Position Overview: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:Quality Management System - 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.
Product Quality Complaints Management- 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.
DSCSA Compliance- 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.
Production Oversight- 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.
Cross-function collaboration and Quality Support - 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 audits and inspections, providing documentation and responses as needed.
- Other QA-related duties as assigned by management.
Qualifications and Experience - Bachelor'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 Competencies - Quality and compliance mindset
- Cross-functional collaboration
- Accountability and attention to detail
Location and Work ArrangementThis position is based in Burlington, Massachusetts, and follows a hybrid work model requiring on-site presence three days per week.
The 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 coverage
- Dental and vision coverage
- Generous paid time-off
- 401(k) retirement plan with competitive company match
- Medical & Dependent Care Flexible Spending Account
- Up to $150 monthly cell phone reimbursement
- Employee Assistance Program
