Quality Engineer August Bioservices
Overview
Quality Engineer at August Bioservices leads quality initiatives for new client projects across R&D Formulation Development Clinical and Commercial Manufacturing. This role drives technology transfer supports regulatory compliance and collaborates with cross-functional teams to ensure successful product introductions.
What You'll Do11
- 1Represent Quality function in internal and external meetings regarding new client projects and determine deliverables and timelines
- 2Support technology transfer of product and processes from clients into August Bioservices manufacturing and laboratories
- 3Identify CMC critical path items risks and drive solutions to mitigate transfer impediments
- 4Provide feedback in Change Review Board for change controls introducing new products
- 5Develop phase appropriate strategies for efficient transfers and identification of Quality deliverables
- 6Work with Product Quality Assurance and Manufacturing to generate appropriate batch documentation
- 7Communicate project status upcoming deliverables and timeliness to the Quality Organization
- 8Collaborate with Manufacturing Engineering Supply Chain and Commercial Operations to drive technical transfer
- 9Support internal audits and regulatory inspections while adhering to ICH FDA and 21 CFR guidelines
- 10Maintain clear communication with cross-functional teams and clients to move projects forward
- 11Drive continuous improvement in quality processes and maintain compliance standards
Requirements5
- 1Bachelor’s or Master’s Degree with 5+ years of QA experience in biotechnology biologics or pharmaceutical manufacturing
- 2Proven track record with CMC and technology transfer
- 3Deep understanding of GMP compliance including 21 CFR Parts 210 211 820 and PICS Guide Part 1 2
- 4Familiarity with FDA guidance on aseptic processing and Part 11 compliance preferred
- 5Strong technical skills in quality assurance and process validation
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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