Job Title: Quality Operations Compliance Specialist
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About the Role:
* We are seeking a highly skilled and experienced Quality Operations Compliance Specialist to join our team.
* This role ensures that all products leaving our site meet company, regulatory, and end-user quality standards.
* The ideal candidate will have strong knowledge of regulatory requirements and experience in aseptic processing, preferably gained within a quality or operations role.
* Responsibilities include leading investigations arising from product or manufacturing processes non-compliance, reviewing batch records, and administering quality logs.
* The successful candidate will be responsible for driving continuous improvements and simplifying site processes and procedures to maintain compliance at all times.
* A strong understanding of quality management principles and experience in a GMP environment is essential.
Key Responsibilities:
1. Leading Investigations: Investigate and resolve issues related to product or manufacturing processes non-compliance.
2. Batch Record Review: Review and audit completed batch records to ensure compliance with company and regulatory standards.
3. Quality Log Administration: Maintain and administer quality logs, including QA hold and sample requests.
4. Manufacturing Support: Provide support to the manufacturing team, including reviewing manufacturing logs and completing quality reviews of operations documentation.
5. Continuous Improvement: Identify areas for improvement and implement changes to simplify site processes and procedures.
Requirements:
* Bachelor's degree in a science, quality, or engineering discipline.
* Minimum three years' experience in a quality/operations role in a highly regulated GMP environment.
* Experience in aseptic processing, preferably gained within a quality or operations role.
* Strong knowledge of regulatory requirements and quality management principles.
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