Specialist I/II/III, QA (Batch Release)

The Opportunity

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 in support of business needs including maintaining batch status and ability to communicate release needs throughout the organization.

The Role

• Ensures compliance with regulatory requirements, internal/external guidelines, SOPs, specifications related to record review and product release
• Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities
• 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
• Ability to identify non-compliances impacting release and report as appropriate for resolution
• Participates as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams
• Responsible for release of manufactured material, including virus seed and monobulk
• Authors/reviews SOPs
• Ensures site readiness for regulatory inspections

Your skills and experience

• Bachelor’s degree in Science / Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry.
• 3+ years’ experience in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry or equivalent.
• Sterile product manufacturing knowledge preferred. Biopharmaceutical experience a plus.
• Must have strong interpersonal, written and oral communication skills
• Prior batch release experience required
• Strong computer skills and SAP knowledge preferred
• Ability to problem solve and ensure issue resolution

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

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.