Quality Assurance Associate
4 days ago
The Quality Assurance Associate is responsible for ensuring the quality and compliance of manufacturing operations for solid oral dosage products. This role involves oversight of manufacturing activities, testing of in-process and finished product samples, and maintenance of quality records.
The ideal candidate will have a strong understanding of cGMP and CFR guidelines, as well as experience in a regulated GMP manufacturing environment. A bachelor's degree in a related science or technical field is preferred, along with 2 years of prior relevant work experience.
Key Responsibilities:
- Review and approve manufacturing batch records and testing results
- Conduct real-time audits of manufacturing operations to ensure compliance with cGMP and CFR guidelines
- Perform testing of in-process and finished product samples to ensure quality and compliance
- Maintain quality records and reports, including deviation reports and CAPAs
- Collaborate with cross-functional teams to resolve quality issues and implement process improvements
Requirements:
- Bachelor's degree in a related science or technical field
- 2 years of prior relevant work experience in a regulated GMP manufacturing environment
- Strong understanding of cGMP and CFR guidelines
- Excellent communication and problem-solving skills
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