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Senior Associate QA, International Affiliates
4 weeks ago
We are seeking a highly motivated individual to join our Global Distribution Quality (GDQ) team as a Senior Associate QA, International Affiliates. This is an exciting opportunity to join a team of quality professionals who play a critical role in upholding the integrity and reliability of our quality standards. The ideal candidate will implement internal collaboration with global quality teams, manufacturing sites, and external logistic partners, supporting our quality systems and continuous improvement initiatives.
Roles & Responsibilities
- Quality Record Management: Perform the QA Contact role on Product and Distribution Complaint records and support other QMTS records, such as Quality Events, Change Control records, and CAPA. You will manage quality records, including those for product recalls and returned goods.
- Audits and Compliance: Support audits, including self-inspections and external vendor audits, ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP). You will ensure accurate, complete, and timely documentation of all quality records.
- Process Improvement: Identify and lead initiatives for process improvement, driving quality and operational efficiency through structured methodologies. You will collaborate with cross-functional teams to implement best practices and promote a culture of quality excellence.
- Stakeholder Communication: Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs. You will also develop quality reports and metrics to track key performance indicators (KPIs).
Technical Skills
- Strong understanding of GMP/GDP requirements and pharmaceutical regulations.
- Familiarity with logistics processes for parcel, transport, and warehousing providers.
- Experience in final release and QMTS processes in global markets.
- Strong technical writing skills.
- Experience with Microsoft Office Tools, including Excel, Word, and PowerPoint.
Qualifications
- A Bachelor's degree in science or engineering with professional experience in related fields.
- Strong continuous improvement mindset and lean practices experience is preferred.
- Understanding of end-to-end supply chain business processes is a plus.
- Experience in project management across multiple departments and geographies is preferred.
Soft Skills
- Problem-Solving: Strong analytical and problem-solving skills, with quick process understanding and insight.
- Communication: Effective written and verbal communication skills, with the ability to communicate across all levels of the organization.
- Proactiveness: Independent self-starter, able to work autonomously and under pressure.
- Attention to Detail: Energetic, detail-oriented, and highly motivated with a can-do attitude.
- Collaboration: Strong team-oriented mindset with the ability to multi-task and prioritize.
