Manufacturing Quality Systems Specialist Fill Finish

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

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 state-of-the-art 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.

The Manufacturing Quality Systems Specialist supports Fill Finish manufacturing operations by leading investigations ensuring quality system execution and providing technical expertise across multiple unit operations. You will maintain compliance within a cGMP environment while driving continuous improvement through root cause analysis to ensure corrective and preventative actions documentation practices and collaboration.

Responsibilities

Manage deviations including authorship of comprehensive product impact assessments.
Lead crossfunctional investigation teams to perform root cause analysis and identify sustainable corrective actions.
Develop implement and monitor CAPA plans aimed at preventing recurrence of quality events.
Perform Product Technical Complaint and Adverse Event investigations ensuring timely and compliant resolution.
Write and revise SOPs batch records and other controlled documents to support Fill Finish operational activities.
Author Biological Product Deviation Reports (BPDRs) for submission to the FDA ensuring accuracy and regulatory compliance.
Oversee change controls including complex and sitewide change control activities.
Provide technical support across multiple Fill Finish unit operations; identify troubleshoot and resolve technical and process-related issues.
Develop and deliver technical training materials to support manufacturing processes and employee development.

Minimum Qualifications

Bachelors degree in a Science or Engineering discipline or equivalent industry experience.
Minimum of 1 year of experience in deviation management root cause analysis CAPA execution and change control preferably within the pharmaceutical or biotech industry.
Demonstrated experience working in a cGMP environment.
Troubleshooting skills with the ability to navigate complex technical issues.
Organizational planning and timemanagement skills.

Benefits: Medical Dental Vision Life Insurance 401K and PTO available from your first day of hire.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit our On the Front Line video to learn more about CSL Seqirus

Required Experience:

Responsibilities

Manage deviations including authorship of comprehensive product impact assessments.
Lead crossfunctional investigation teams to perform root cause analysis and identify sustainable corrective actions.
Develop implement and monitor CAPA plans aimed at preventing recurrence of quality events.
Perform Product Technical Complaint and Adverse Event investigations ensuring timely and compliant resolution.
Write and revise SOPs batch records and other controlled documents to support Fill Finish operational activities.
Author Biological Product Deviation Reports (BPDRs) for submission to the FDA ensuring accuracy and regulatory compliance.
Oversee change controls including complex and sitewide change control activities.
Provide technical support across multiple Fill Finish unit operations; identify troubleshoot and resolve technical and process-related issues.
Develop and deliver technical training materials to support manufacturing processes and employee development.

Minimum Qualifications

Bachelors degree in a Science or Engineering discipline or equivalent industry experience.
Minimum of 1 year of experience in deviation management root cause analysis CAPA execution and change control preferably within the pharmaceutical or biotech industry.
Demonstrated experience working in a cGMP environment.
Troubleshooting skills with the ability to navigate complex technical issues.
Organizational planning and timemanagement skills.

Benefits: Medical Dental Vision Life Insurance 401K and PTO available from your first day of hire.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.