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Alvotech

QA On The Floor Specialist

Alvotech Reykjavik, Iceland

Biotechnology Research · 501-1,000 employees

3 d ago
qa Mid (2-5 yrs) Full-time Iceland
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About the role

Provide real-time QA support for manufacturing operations, including monitoring shop floor activities and ensuring compliance with GMP and GDP standards. Manage batch-related issues, deviations, CAPAs, and oversee area releases and documentation reviews.

What they look for

Quality Assurance GMP GDP ALCOA principles Manufacturing operations Deviations CAPA Batch documentation Line clearance AQL sampling Visual inspection SOP updates Problem-solving Communication Collaboration Attention to detail

Requirements

Requires a Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field. Candidates must have at least 2 years of experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.

Benefits

Personal growth support Internal career development Company social events Milestone celebrations In-house canteen Coffee house Exercise and well-being support On-site shower facility Transportation grant Internet at home

Full description

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.

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