QA Batch Release Specialist (Raw materials, Intermediates, and Finished Product)

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 4 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.

Reporting to the QA Manager the QA Specialist supports review of batch documentation and release of internal and external commercial products while ensuring compliance with cGMPs site SOPs and regulatory requirements. Ability to prioritize record review and usage decisions to support business needs and communicating release needs throughout the organization.

Responsibilities:

Responsible for certification and/or rejection of incoming material manufactured material including intermediates buffers virus seed monobulk and drug product in compliance with applicable licenses and legal requirements. Ensures compliance with regulatory requirements internal/external guidelines SOPs and specifications related to record review and product release.
Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution.
Work closely with key stakeholders concerning batch release requirements.
Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
Ensure site readiness for regulatory inspections. Represents batch release area in Health Authority inspections as an SME.
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities. Authors reviews and QA approves Standard Operating
Procedures (SOPs) protocols/reports work instructions etc.
Creates and maintains QA SAP Master Data builds in support of batch release.
Data population and approval of Lot Release Protocols. Supports Lot Release Protocol revisions and GLIMS data builds for LRPs.
Responsible for change control evaluations/actions to assess batch release impact and actions. Supports batch disposition assessment for deviations as needed.
Gathers reviews and verifies data for the Annual Product Reviews.
Ability to answer batch release questions/inquiries train or coach through progression of experience/knowledge.

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:

Responsible for certification and/or rejection of incoming material manufactured material including intermediates buffers virus seed monobulk and drug product in compliance with applicable licenses and legal requirements. Ensures compliance with regulatory requirements internal/external guidelines SOPs and specifications related to record review and product release.
Ability to identify non-compliances impacting release and report/escalate as appropriate for resolution.
Work closely with key stakeholders concerning batch release requirements.
Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
Ensure site readiness for regulatory inspections. Represents batch release area in Health Authority inspections as an SME.
Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities. Authors reviews and QA approves Standard Operating
Procedures (SOPs) protocols/reports work instructions etc.
Creates and maintains QA SAP Master Data builds in support of batch release.
Data population and approval of Lot Release Protocols. Supports Lot Release Protocol revisions and GLIMS data builds for LRPs.
Responsible for change control evaluations/actions to assess batch release impact and actions. Supports batch disposition assessment for deviations as needed.
Gathers reviews and verifies data for the Annual Product Reviews.
Ability to answer batch release questions/inquiries train or coach through progression of experience/knowledge.

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.