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Manufacturing Quality Assurance Engineer Night Shift - Agilent Technologies
QA Engineer
Night‑shift Manufacturing Quality Assurance Engineer responsible for ensuring nucleic acid therapeutics meet GMP and FDA standards through rigorous documentation, audits, and statistical process control.
About the role
Key Responsibilities
- Develop, implement, and maintain quality systems and SOPs for nucleic acid therapeutic manufacturing.
- Conduct internal and external audits, ensuring compliance with GMP, FDA, and other regulatory requirements.
- Perform root cause analysis and corrective action plans for quality deviations and nonconformities.
- Utilize statistical process control tools to monitor and improve manufacturing processes.
- Prepare and review quality documentation, batch records, and regulatory submissions.
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, or related field.
- 3+ years of quality assurance experience in a biopharma or pharmaceutical manufacturing environment.
- Strong knowledge of GMP, FDA regulations, and quality management systems.
- Proficiency in root cause analysis, CAPA, and statistical process control.
- Excellent written and verbal communication skills, with attention to detail.
Skills
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