Specialist II, QA (Quality Engineering)
- Employer
- CSL Behring
- Location
- Holly Springs, North Carolina
- Start date
- Nov 22, 2021
View more
- Discipline
- Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
Job Purpose
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.
Our Benefits
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
About Seqirus
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.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
Do work that matters at Seqirus!
Company
As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.
CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.
CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!
Stock Symbol: CSL
Stock Exchange: Australian Securities Exchange
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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