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.

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.