We are currently seeking Quality Assurance Scientists at several levels to join the quality team to support product development at a global biotech leader.
Requirements of the Quality Assurance Scientist I, II:
- Advanced degree in life science, chemistry or biochemical field with minimum 4 years experience with technical support, QA, process development or manufacturing OR Bachelor’s degree with 10+ years relevant experience in biotech industry.
- Hands on experience and working knowledge of QA systems in manufacturing, product development and/or process development.
- Technical knowledge of in molecular biology, genomics, cell culture, protein chemistry, enzyme development, DNA or RNA polymerases or related subjects.
- Skilled in statistical application and analysis of Quality Assurance activities and data.
Responsibilities of the Quality Assurance Scientist I, II:
- Approve, audit and review batch records for inventory and manufacturing.
- Review and approve Quality Control Protocols (QCP), product labels, testing plans, product information specification sheets, technical bulletins and technical manuals.
- Review and approve batch records, labels, product literature, deviations, process changes, and CAPA’s.
- Assess the impact of nonconforming components.
- Review, participate and implement CAPA’s, audits and complaint investigation planning.
- Perform process and product validations.
- Lead cross functional meetings to communicate findings.
- Write SOP’s.
Occupational Category: 19-1099
: Please apply using the form or send your resume to Debbie Winkelbauer