QA Associate II
Company: International Biopharmaceutical
ocation: Amsterdam Area
Starting date: 1 March
Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. That means a fast moving and constantly changing environment, where discoveries are made every day.
Responsibilities (include but are not limited to):
The Quality Systems Archive Specialist (QA Associate) will use the electronic Document Management System and enterprise resource planning (ERP) to issue controlled documents and labels.
• Maintain a document management system compliant with regulatory, quality and requirements
• Manage and maintain the archival of documents and records such that required documentation is retrievable and files are accurate, complete and well organized.
• Provide guidance and advice on approved procedures, standardization and requirements associated with the document management system
• Working knowledge of quality systems requirements
• Support tracking and communication of site metrics to management.
• Identify and escalate compliance GAPS across the archive system
• Provide support for audits and regulatory agency inspections.
• Provide general support for the overall Quality System.
• 2+ years of relevant experience in a GMP environment related field
• Completed MBO+/HBO studies preferably in a pharmaceutical or scientific discipline
• Working knowledge of electronic documentation systems, data retrieval, and electronic file formats.
• Detail oriented with solid problem-solving acumen.
• Ability to work effectively in a team environment.
• Demonstrates critical thinking, problem-solving skills
• Experience generating metrics preferred.
• Proficient in MS Word, Excel, and Power Point
• Demonstrates good interpersonal, verbal and written communication skills, which are essential in this collaborative work environment.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• English required and Dutch a plus
If you are interested in this position, please apply or email email@example.com