Specialist II, QA (Quality Engineering)
The incumbent will be a member of the QA-Engineering team at the Holly Springs Influenza Vaccine manufacturing facility, supporting QC/Bulk and/or Fill-Finish Operations.
The QA-Engineering Specialist applies Seqirus quality principles related to equipment qualification, method validation, process validation, Cleaning validation, shipping validation, and technology transfers. Utilizes integrated commissioning and qualification principles to ensure compliance of equipment and system qualification. Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.Major Accountabilities:
- Ensures that qualification, validation, and technical protocols, and reports comply with site SOPs. Provides review and approval of related documents.
- Provides QA oversight to equipment qualification, technical transfers, process, method, cleaning and computer system validation including revalidation and re-evaluation.
- Provides validation documentation lifecycle oversight.
- Ensures technical transfer plans and validation plans adhere to Seqirus standards.
- Utilizes data analysis skills and statistical tools to interpret results in support of acceptance criteria and regulatory requirements
- Interfaces with customers and partners on quality related issues, participates as the QA representative on multi-functional continuous improvement teams, and ensures efficient and timely project support.
- Bachelor’s degree in Science or Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry.
- Minimum of 3 years’ experience in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry or equivalent.
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Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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