QA On The Floor Specialist

Join Alvotech’s Quality Assurance team and play a key role in supporting manufacturing operations while ensuring compliance with GMP requirements and quality standards. This hands-on position provides real-time QA support to manufacturing teams and contributes to the delivery of high-quality biopharmaceutical products.

Please note that this is a rotational shift position, requiring flexibility to support manufacturing operations across designated shifts in a 24/7 production environment.

Scope and Responsibilities

• Act as the primary QA contact for DPM and DSM operations during rotational shifts.
• Provide QA support for batch-related and facility issues, including deviations and CAPAs.
• Perform shop floor monitoring and ensure compliance with GMP, GDP, and ALCOA principles.
• Review manufacturing documentation, alarm logs, and failure assessments.
• Approve area release, line clearance, and other QA-controlled activities.
• Support media fills, cell bank issuance, AQL sampling, and visual inspection activities.
• Maintain QA documentation and support inspection readiness and audits.
• Contribute to SOP updates and train new QA team members as needed.

Job Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
• Minimum 2 years of experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Strong knowledge of GMP, quality systems, documentation practices, GDP, and ALCOA principles.
• Experience supporting manufacturing operations and quality oversight activities.
• Strong attention to detail and problem-solving skills.
• Excellent communication and collaboration abilities.
• Ability to work rotational shifts in a fast-paced manufacturing environment.
• Proficient in written and spoken English.

What we offer

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration, and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and well-being support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.
• Internet at home for full-time employees.