Category

Description

• Maintain and continuously improve quality system processes and procedures.
• Review documentation supporting GMP activities for accuracy and completeness.
• Release Batch Records and labeling for manufacturing.
• Review executed Batch Records and associated test results.
• Coordinate or perform investigations of quality issues and product complaints and implement corrective/preventive actions.
• Review change controls and validation documentation.
• Assist with internal audits and supplier audits as needed.
• Monitor performance of quality systems and generate reports to communicate status to management.

• Bachelor’s Degree in Science or related technical field.
• 3+ years’ of experience in pharmaceutical, biotech or medical device industry.
• Excellent organizational skills and attention to detail.
• Good verbal and written communication skills.
• Strong interpersonal skills and ability to work efficiently on a team.
• Ability to make decisions and resolve issues with minimal guidance.
• Knowledge of FDA and international regulations and GxP guidelines.

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