We are working with a large Biotechnology company in South San Francisco looking to add a Quality Specialist I to come join the team! This position will start as a 6 months contract.
Quality Specialist I Primary Responsibilities
- Must be able to support establishment of GxP, SOP and Documents policies to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations.
- You will be working in collaboration with supported functional areas and key business stakeholders.
- Demonstrate knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements
- Collaborates with a network of subject matter experts (SMEs) across the functional areas, supporting Policy, SOP and Supporting Document development.
Skills needed for Quality Specialist I:
- Experience developing documents simultaneously to high quality In-depth knowledge of pharmaceutical development processes, including Quality Management Systems, and relevant GxP regulations.
- Support internal process improvement projects.
- Fluency in written and spoken English.
- Can successfully manage cross-functional and interdisciplinary teams.
- Broad understanding of global expectations of Health Authorities in the area of Pharma Development.
- 3-5 years in the pharmaceutical industry, preferably in pharmaceutical development and working in a GxP regulated area.
We are actively interviewing so don't hesitate to Apply Now!
