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. You will provide real‑time QA support to manufacturing operations in a 24/7 environment, ensuring compliance with GMP, GDP and ALCOA principles while helping deliver high‑quality biopharmaceutical products.
Key responsibilities
- Act as the primary QA contact for DPM and DSM operations during rotational shifts.
- Support batch‑related and facility issues, including deviations and CAPAs.
- Perform shop‑floor monitoring and enforce GMP, GDP, and ALCOA compliance.
- Review manufacturing documentation, alarm logs, and failure assessments.
- Approve area release, line clearance, media fills, cell bank issuance, AQL sampling and visual inspection activities.
- Maintain QA documentation, support inspection readiness and audits.
- Contribute to SOP updates and train new QA team members as needed.
Required profile
- 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 attention to detail, problem‑solving abilities and excellent communication skills.
- Willingness to work rotational shifts in a fast‑paced production setting.
- Proficient in written and spoken English.
Required skills
- GMP knowledge
- GDP knowledge
- ALCOA principles
- CAPA handling
- AQL sampling
- Visual inspection techniques
What we offer
- Opportunity to work on ambitious projects that impact patients' lives.
- International, diverse and inclusive work culture.
- Flexible, innovative environment with personal growth support.
- Company social events, on‑site canteen, coffee house and shower facilities.
- Transportation grant, home internet support and well‑being programs for full‑time employees.
Questions fréquentes
Why are you reporting this job?
Apply in 30 seconds
Enter your email to apply. An account will be created automatically.
By continuing, you accept our terms of use.
Already have an account? Login
Published 1 mánuður síðan
Expires 1 vika síðan
37 views · 0 interested
Boost your chances
Upload your CV — we will match you with relevant openings.
Analyzing your CV...
Alvotech
Reykjavik