About this role
Role Overview
- Perform the following daily functions, including but not limited to: review of deviations, investigations, and CAPA
- Ensure the integrity and traceability of all data generated and reported
- Provide support to other departments such as Production, Quality Control, Validation, and Engineering
- Develop and report quality metrics for deviations and other systems, as assigned
- Assume additional responsibilities under the quality system program, as trained and assigned
Requirements
- Bachelor's degree in Science required (preferably in Microbiology, Chemistry, or Biology)
- Minimum 2–3 years of Quality Assurance experience in the biopharmaceutical or pharmaceutical manufacturing industry
- Specialist-level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA, and risk assessments)
- Demonstrated judgment, technical competence, and subject-matter knowledge essential to the role
- Able to apply, follow, and rigorously maintain rules, regulatory requirements, procedures, and processes
- Able to work independently and as part of a team
Benefits
- Proficient computer skills with MS Office and Adobe Acrobat
- Strong organizational skills, with attention to detail and ability to meet deadlines