Quality Control Analyst

Responsibilities

• Perform batch release testing in QC Chemistry and Microbiology areas.
• Conduct chromatographic analyses including HPLC and Gas Chromatography.
• Execute microbiological routine tests and microbial limits testing.
• Maintain robust and compliant cGMP documentation practices.
• Support equipment and instrument calibration program.
• Participate in strategic projects and external team initiatives.
• Collaborate in investigations and implement corrective actions.
• Manage deviations, CAPA, Change Control, and other quality tools.
• Support method validation and author protocols and reports.
• Assist and contribute to training programs for employees.
• Represent QC in audits and inspections with Health Authorities.

Requirements

• Required Skills:
• 3+ years of relevant experience in Quality Control.
• Bachelor's degree in Pharmaceuticals or related Science fields.
• Excellent written and verbal communication skills in Portuguese and English (advanced level).
• Preferred Skills:
• Master's degree or higher.
• Job Level: Professional
• Why Biogen?

Benefits

Additional Information

About This Role: As a Quality Control Analyst, you will be a vital member of the Quality Control Lab, contributing to both the independent execution of laboratory activities and collaborative strategic projects. In this mid-level role, your expertise will span across QC Chemistry and Microbiology areas, where you will perform batch release testing and associated activities such as assay & impurities, pH, moisture, and chromatographic analyses. You will be responsible for ensuring robust and compliant cGMP documentation practices, maintaining data integrity, and adhering to GMP requirements to uphold quality standards. Your role will involve supporting equipment and instrument calibration programs, participating in key initiatives with external teams, and providing guidance to team activities as directed by management. Your collaboration will extend to investigations and compliance assessments, utilizing quality tools for managing deviations and corrective actions. Additionally, you will support method validation, author protocols and reports, and contribute to training programs. This position requires a good understanding of Health Authorities' regulations, representing QC in audits and inspections, and the ability to work effectively across all business areas and levels of the organization.

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