QA On The Floor Specialist
Alvotech · Reykjavik
Job description
About the role
Join Alvotech’s Quality Assurance team as a QA On The Floor Specialist, providing real‑time QA support to manufacturing operations in a 24/7 environment. This hands‑on position ensures compliance with GMP, GDP and ALCOA principles while contributing to the delivery of high‑quality biopharmaceutical products.
Key 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, 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, support inspection readiness and contribute to SOP updates.
Required profile
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology or related field.
- Minimum 2 years experience in a GMP‑regulated pharmaceutical or biotechnology manufacturing environment.
- Strong attention to detail, problem‑solving abilities and excellent communication skills.
- Willingness to work rotational shifts in a fast‑paced manufacturing setting.
Required skills
- GMP
- GDP
- ALCOA principles
- CAPA management
- SOP development and implementation
What we offer
- Opportunity to work on ambitious projects that impact patients’ lives.
- International, diverse and inclusive work culture.
- Flexible and innovative work environment with personal growth support.
- Company canteen, coffee house, on‑site shower facilities and wellness programs.
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Published 1 klukkutími síðan
Expires 1 mánuður síðan
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Alvotech
Reykjavik