Quality Assurance Specialist
6 hours ago
About the Role:
The Quality Assurance Analyst plays a crucial role in ensuring the quality of drug substance manufacturing and supporting areas. This involves collaborating with the Drug Substance Quality Operations team and other project teams to implement consistent policy administration, QA oversight of daily activities, and resolving or mitigating issues that occur during operations.
Key Responsibilities:
- Supports QA for project deliverables in accordance with governing processes and procedures within the assigned Quality area.
- Participates or supports assigned Quality audits as applicable.
- Reviews and approves batch processing documentation.
- Assists with reviews and approval of Standard Operating Procedures and Work Instructions.
- Participates in risk assessments and assists in mitigating quality-related risks.
- Reviews and approves records within the eQMS such as Change Assessments and Investigations.
Requirements:
- Bachelor's Degree with a scientific discipline (e.g., Engineering, Applied Science, or Chemistry) with 0-2 years of experience.
- Basic experience or understanding of GMP, GLP, GDP requirements.
- Experience in a GxP pharmaceutical manufacturing environment and/or biopharma startup environment with QA experience (preferred).
Working Environment:
The Quality Assurance Analyst will work in a fast-paced environment, collaborating with cross-functional teams to ensure the quality of drug substance manufacturing. The ideal candidate will have excellent communication and problem-solving skills, with the ability to work independently and as part of a team.
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