KBI
QA Manufacturing Specialist II (Nights)
USA - NC - Durham - National Way · Mid
Sponsorship not specifiedDetected 13 days ago
ReactSAPProcess ImprovementGMPCell CultureProtein AnalysisMicrosoft Office
About the role
- The QA Manufacturing Specialist is responsible for ensuring raw materials, products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations.
- This position will be responsible for on the floor review of executed records (batch record section review, solution records, equipment records, and logbooks) supporting all aspects of cGMP operations.
- Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations, CAPAs, and other compliance issues in a timely manner
Responsibilities
- This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing.
- Client and regulatory audit/inspection support is also within job scope.
- Support Manufacturing changeover process.
- Support client audits and regulatory inspections and client batch record review process.
- Support QA Raw Material group with release of raw materials
- Support process improvement projects to include improving the lifecycle of batch record review cycle times and batch release dates.
Requirements
- MQA Specialist II: BS/BA in scientific field and 5 years experience or MS/MA degree and 3 years' experience in a QA GMP regulated environment within Biopharmaceuticals or equivalent is required.
Nice to have
- Knowledge of US and EU cGMP guidelines/regulations is desired.
- Experience with electronic document management systems, SAP and Microsoft Office suite are preferred.
- Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
- Knowledge of biopharmaceutical manufacturing including cell culture, protein purification, and single-use platform technology is preferred.
This listing is sourced directly from KBI's careers page and normalized into a canonical job model.