Quality Assurance Operations Analyst
2 weeks ago
About Us: Compass Consulting is dedicated to advancing healthcare solutions through innovative therapeutics aimed at addressing serious and life-threatening rare genetic disorders.
Position Overview:
This role, reporting to the Quality Assurance Supervisor/Manager/Senior Manager, is pivotal in ensuring quality compliance across various processes involved in the manufacturing and release of products.
Key Responsibilities:
- Oversee quality assurance for multiple operational facets, ensuring adherence to Good Manufacturing Practices (GMP).
- Conduct direct observations of manufacturing processes to verify compliance with established standards.
- Review and assess GMP documentation, including logbooks, batch records, and testing documentation.
- Issue Production Batch Records to the manufacturing team.
- Manage the scanning and archiving of completed production batch records.
- Ensure that manufacturing and quality control operations align with company policies, regulatory requirements, industry standards, and GMP regulations.
- Possess a working knowledge of regulatory requirements and guidelines from the United States and Europe, with additional jurisdictions being a plus.
- Revise quality assurance-related procedures as necessary to maintain compliance and efficiency.
Qualifications:
- Associate's Degree is required; Bachelor's Degree is preferred.
- Strong attention to detail is essential.
- Proficiency in MS Office applications.
- Ability to operate standard office equipment effectively.
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