Quality Assurance Engineer – 12‑month contract
AbbVie · Heredia
Descripcion del puesto
About the role
The Quality Assurance Engineer will support manufacturing quality functions at AbbVie’s plant, ensuring compliance with cGMP, company policies, and regulatory standards. This 12‑month temporary position involves investigation of deviations, product impact analysis, and implementation of corrective actions.
Key responsibilities
- Implement and maintain the effectiveness of the Quality System and ensure all quality goals are met.
- Lead investigations of plant events, document findings, and feed results into the CAPA system.
- Perform product impact analyses, place products on QA hold when required, and support batch release for specific U.S. sites.
- Approve SOPs, calibration requests, and review critical maintenance routines.
- Audit commissioning and validation documentation, author new qualification/validation protocols, and develop product quality plans, specifications, risk analyses and FMEAs.
Required profile
- Bachelor’s degree in Biology, Chemistry, Engineering or related field.
- Minimum 6 years of experience in manufacturing, quality or engineering within the pharmaceutical industry.
- Strong English proficiency (B2+) and ability to work in an English‑speaking environment.
- Valid visa and passport for the work location.
- Excellent verbal and written communication, problem‑solving and interpersonal skills.
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Publicado hace 1 hora
Expira en 1 mes
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AbbVie
Heredia