Manufacturing Quality Systems Specialist
Manufacturing Quality Systems Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges Seqirus has an exciting opportunity to join our expanding team in Holly Springs NC. With the stateoftheart manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company drawing together expert staff from different countries to collaborate. Together were working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus you join a team dedicated to making a difference in peoples lives. Its a feeling of possibility creativity and purpose that inspires us every day.
Reporting to the Manager Manufacturing Quality Systems you will work onsite in the Holly Springs office. You will be responsible for providing quality system support to Fill Finish manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs NC. Benefits Include Onsite Caf Medical Dental Vision Life Insurance 401K and PTO available from your first day.
Responsibilities
- Owns deviations and writes product impact assessments.
- Leads cross functional investigation teams in root cause analysis
- Creates and executes CAPA plans to reduce the likelihood of reoccurrence.
- Writes SOPs and batch records to support operation activities
- Owns change controls including site wide change controls.
- Writes Biological Product Deviation Report for submission to the FDA.
- Performs Product Technical Compliant and Adverse Event investigations.
- Provides technical support with multiple unit operations. Identifies solutions to address technical problems.
- Writes technical training material for manufacturing processes.
Minimum Qualifications
- Bachelors degree in Science or Engineering or equivalent industry experience required.
- Minimum of 1 years of experience with deviation investigations root cause analysis CAPA management and Change Controls or equivalent experience in the pharmaceutical industry.
- Direct experience within a cGMP environment
- Demonstrated troubleshooting skills
- Strong organizational planning and time management skills
- Strong oral written and interpersonal communication skills
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
#LIOnsite
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits from health care to financial protection so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family need help paying for emergency back up care or summer camp looking for mental health resources planning for your financial future or supporting your favorite charity with a matching contribution CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see whats available to you as a CSL Seqirus employee.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35 countries CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
Watch our On the Front Line video to learn more about CSL Seqirus
Required Experience:
Unclear Seniority
Employment Type
Full-Time
