Specialist I/II/III, QA (Front Line) (2nd Shift)

Specialist I/II/III, QA (Front Line) 2nd Shift

The Front Line Quality Assurance (FLQA) Specialist will provide on the floor support to manufacturing (bulk, sterile formulation/filling, and packaging), laboratories, utilities, maintenance, and logistics at the Holly Springs site. Core responsibilities of this role include quality walkthroughs on the floor, GMP record reviews and approvals, and real time triage of quality related issues.

This position is for a 2nd shift FLQA Specialist role working Tuesday -Friday 2:00pm-12:30pm. Candidate must be flexible in their shift schedule to support the business and the seasonal needs of influenza vaccine production.

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

Major Accountabilities

• Perform real time batch record/logbook/document review concurrent with manufacturing, QC, or warehouse operations on the floor
• Perform routine quality walkthroughs of site GMP facilities and operations
• Act as the quality representative on the floor during troubleshooting and issue resolution. Escalate potential product or process related issues as needed.
• Provide quality oversight of site critical alarm reports and corrective maintenance program
• Support the development, revision and implementation of SOPs, protocols, and other GMP documents
• Provide oversight of the site’s quality systems and compliance
• Use of computerized systems: SAP, TrackWise, GLIMS, Delta V, and BAS
• Utilize knowledge of root cause analysis and risk based decision-making
• Collaborate with cross-functional teams while triaging issues and when pursing improvements
• As needed, supports greater FLQA organization including quality approval of deviations and/or change controls, quality support of suite teams, and quality representation on site projects. 
• Responsible for knowledge of current local and international regulatory requirements
• Provide advice and appropriate technical support on all quality/compliance matters

Minimum Requirements

• Bachelor’s degree in Science/ Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry
• Minimum 1+ year of experience; prefer 3+ years previous experience on the floor or supporting Bulk, Fill Finish, and/or Packaging pharmaceutical operations with technical understanding of the production processes used in the biotechnology industry
• Understanding of the quality requirements for the pharmaceutical industry
• 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
• Demonstrates risk-based decision making

• Experience in root cause analysis, including working experience of root cause analysis tools such as fishbone/5Why

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.