FLQA Specialist

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 13 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 an advanced manufacturing facility and 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 on the front line 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 Sr. Manager of Process FLQA you will work onsite at our Holly Springs NC Facility. You will apply quality principles related to equipment qualification technical transfer process cleaning method and computer system validation and front line support for triage deviation investigation approval and change management. Primary areas of support will be Quality Control Facilities Operations and Warehousing. You will utilize integrated commissioning and qualification principles to ensure compliance. These principles will support the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Additionally you will provide technical support for the US FCC site in all cGMP compliance related matters. This includes assurance that all aspects comply with cGMPs legal and regulatory requirements.

Responsibilities:

Ensure that qualification validation and technical protocols and reports comply with site SOPs. Provide review and approval of related documents
Provide QA oversight to equipment qualification technical transfers process method cleaning and computer system validation including revalidation and re-evaluation
Maintain audit program reviewing functional and release documentation and reviewing and approving deviation investigations relevant to area(s) of responsibility
Review lot release documentation and Facilitate compliant release process for corresponding market
Respond to questions from authorities (Swissmedic FDA etc.) to ensure timely product release
Ensure standard operating procedures (SOPs) stay current and align with corporate and regulatory requirements
Interface with customers and partners on quality related issues
Execute training/awareness related to GMP standards
Provide training on quality concepts and tools

Qualifications:

University degree in a relevant scientific discipline (Pharmacy Chemistry Biology Biochemistry)
3 years GMP experience in pharmaceutical/biotech or other regulated industry
Knowledge of current Good Manufacturing Practices (cGMP) principles
Knowledge of FDA and EMA requirements

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:

Ensure that qualification validation and technical protocols and reports comply with site SOPs. Provide review and approval of related documents
Provide QA oversight to equipment qualification technical transfers process method cleaning and computer system validation including revalidation and re-evaluation
Maintain audit program reviewing functional and release documentation and reviewing and approving deviation investigations relevant to area(s) of responsibility
Review lot release documentation and Facilitate compliant release process for corresponding market
Respond to questions from authorities (Swissmedic FDA etc.) to ensure timely product release
Ensure standard operating procedures (SOPs) stay current and align with corporate and regulatory requirements
Interface with customers and partners on quality related issues
Execute training/awareness related to GMP standards
Provide training on quality concepts and tools

Qualifications:

University degree in a relevant scientific discipline (Pharmacy Chemistry Biology Biochemistry)
3 years GMP experience in pharmaceutical/biotech or other regulated industry
Knowledge of current Good Manufacturing Practices (cGMP) principles
Knowledge of FDA and EMA requirements

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