Specialist I/II/III Front Line QA

Specialist I/II/III, Front Line QA(Bulk/QC/Warehouse)

Job Purpose

The Front Line Quality Assurance Specialist will provide strategic and technical support for the Bulk/QC/Warehouse departments at the Holly Springs site in all cGMP compliance related matters to ensure all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements.

This position is for a FLQA Specialists role working Monday-Friday during core business hours. Candidate must be flexible in their schedule to support the business and the seasonal needs of influenza vaccine production.

Candidates may be considered at level I, II or III depending on experience.

Major Accountabilities

• Function as primary FLQA and Quality Management System SME to assigned area(s) of responsibility within Bulk Manufacturing, QC laboratories, and/or Warehouse operations
• Performs the quality review and approval of Deviations, CAPAs, and Change Controls with close collaboration with Record Owners.  Ensures the robust investigation and on time closure of deviations, the development and execution of strong and executable CAPAs, and the technical accuracy and comprehensive scope of change controls within Bulk/QC/Warehouse departments
• Participate in cross-functional suite team meetings and provide FLQA support of suite team projects and initiatives
• Provide on the floor coaching to manufacturing, laboratory, and/or warehouse staff to build quality knowledge and sustain a strong quality culture
• Drives adherence to and continuous improvement of the quality systems within the Bulk/QC/Warehouse departments.
• Support the development, revision and implementation of SOPs, batch records, protocols, and other GMP documents.
• Assists in the delivery of the Deviation, CAPA, and Change Control APQR sub-reports
• Leads improvement projects of medium to large scope and may provide quality support to site capital projects and/or global quality system improvement projects
• Ensures inspection readiness in assigned area of support via performing routine quality walkthroughs, monitoring quality system adherence, and direct involvement in Site Self Inspections
• Function as the QA SME for internal and external audits.
• Use of computerized systems: TrackWise, GLIMS, SAP, CMMS, EDMS, Delta V
• As needed, supports greater FLQA organization in quality oversight of Fill/Finish, Utilities, and Maintenance operations.
• Acquire and maintain knowledge of current local and international regulatory requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.

Minimum Requirements:

• Bachelor’s degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• Minimum of 3+ years' GMP experience in the pharmaceutical/biotech industry
• Previous experience in quality role in an FDA regulated manufacturing or laboratory setting or a strong understanding of the quality requirements for the pharmaceutical industry.
• Previous experience in root cause analysis and risk management, including working experience of root cause analysis tools such as Fishbone/5Why
• Previous experience in ownership and/or approval of GMP deviations, CAPAs, and change controls
• Strong organizational skills and ability to manage multiple tasks at one time
• Ability to follow assignments through to completion within defined timelines
• Strong communication skills, both written and oral
• Strong technical understanding of the production processes used in the pharmaceutical/biotechnology industry
• Strong technical understanding of routine laboratory assays used in the pharmaceutical industry
• Demonstrated knowledge of cGMPs, FDA requirements, Quality Systems, and USP

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.