Job Description
Job Summary
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The Quality Assurance Specialist I supports quality and regulatory compliance within a GMP-regulated environment by reviewing documentation, conducting floor audits, maintaining quality systems, and ensuring adherence to internal procedures and applicable regulations.
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Responsibilities
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- Review and approve quality documents, data, protocols, and reports.
- Conduct floor audits and inspections to ensure GMP compliance.
- Review, write, and approve change controls, deviations, CAPAs, OOS investigations, and raw material specifications.
- Evaluate and release support materials and intermediate products as required.
- Maintain accurate quality records and documentation.
- Assist with SOP development and continuous quality improvement initiatives.
- Support client audits and regulatory inspections.
- Ensure compliance with company policies, SOPs, and required training.
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Qualifications
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- Associate’s degree in Chemistry, Biology, or a related field, with 1–2+ years of GMP experience, or equivalent education and experience.
- Knowledge of GMP regulations, ICH Q7, quality systems, and technical writing.
- Strong written and verbal communication, critical thinking, and problem-solving skills.
- Proficiency in Microsoft Office, including Word, Excel, Outlook, and PowerPoint.
- Ability to manage priorities, work independently, and collaborate effectively across teams.
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