Position Overview:
Working independently, the Quality Assurance (QA) Contact will be responsible for ensuring compliance with GMP/GDP and performing various QA-related activities, including overseeing quality events, change control records, corrective and preventive actions, and distribution complaints.
The role will also include collaboration with third-party vendors to ensure service level alignment, support for logistics providers, and participation in audits and inspections.
Key Responsibilities:
- Quality Event & Change Control:
- Perform the QA Contact role on Quality Events, Change Control records, Corrective and Preventive Actions (CAPAs), and QA triage of Distribution complaints to ensure compliance with regulations.
- End-to-End Process Compliance:
- Work closely with all relevant partners for the end-to-end process and ensure full compliance with GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices).
- Subject Matter Expert (SME):
- Act as a subject matter expert for transportation-related Quality Processes, providing technical and procedural expertise to internal teams.
- 3rd Party Collaboration:
- Collaborate with 3rd parties (e.g., logistics and transportation service providers) to ensure alignment with service levels and to identify opportunities for performance improvement.
- SOP & Documentation Compliance:
- Prepare, review, and approve Standard Operating Procedures (SOPs) and other GMP/GDP documentation, ensuring compliance with corporate, regulatory, and Good Manufacturing Practices (cGMP) requirements.
- Risk Management:
- Understand and incorporate risk management strategies into the overall supply chain strategy to mitigate potential risks.
- Provider Oversight:
- Provide support for logistics service providers and transportation service providers by overseeing their performance and ensuring service compliance.
- Audit & Inspection Support:
- Support internal/external audits and inspections as part of the audit/inspection team, ensuring adherence to regulatory standards.
- Quality Expertise:
- Provide quality expertise and guidance to operational staff and cross-functional teams within Amgen.
- Operational Improvement:
- Take part in operational improvement initiatives, programs, and projects aimed at enhancing efficiency and compliance.
- Supplier Relationship Management:
- Oversee supplier metrics, conduct performance assessments, and manage key documents to maintain strong supplier relationships and identify improvement opportunities.
- Independent Work & Leadership:
- Work with minimal supervision, demonstrating leadership in line with Amgen Values and Leadership Attributes.
Qualifications:
Basic Qualifications & Experience:
- Bachelor's degree in Science or Engineering and 2+ years of professional experience in related fields.
- Understanding of GMP/GDP requirements and their application in pharmaceutical logistics.
- Familiarity with logistics processes for parcel, transport, and warehousing providers.
- Experience in Validation/Qualification of processes, equipment, and facilities.
- Strong technical writing skills, with experience drafting and reviewing documentation.
- Independent, self-starter with the ability to work autonomously under pressure and within teams.
- Knowledge of GMP/GDP and pharmaceutical regulations.
- Energetic, detail-oriented, and highly motivated with a can do attitude.
- Strong change management skills.
- Effective communication skills across all levels of the organization.
- Proficiency with Microsoft Office Tools (Excel, Word, PowerPoint).
- Ability to multi-task and prioritize effectively in a dynamic environment.
What You Can Expect from Us:
At Amgen, we are dedicated to supporting your professional and personal growth, and well-being. As part of our commitment to developing treatments that care for others, we also prioritize your journey every step of the way. We offer:
- Competitive benefits package to support your health and well-being.
- A collaborative culture that encourages continuous learning and career development.
- Opportunities for professional growth within a leading biopharmaceutical company.
