What are the responsibilities and job description for the QA Specialist position at AstrixTechnology LLC?
Our client, a leading contract development and manufacturing organization (CDMO) based in the US, is seeking a QA SPECIALIST to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts.
Responsibilities:
- Oversee inspection and testing of products to ensure quality standards.
- Manage the disposition of materials and release of products.
- Track, document, and report on quality, radiation, and safety goals.
- Author and review SOPs, investigations, and technical reports.
- Identify and address potential risks; perform root cause analysis.
- Conduct internal and external audits and compile detailed reports.
- Train and support quality and production teams.
- Investigate and resolve product complaints and quality issues.
- Develop and update complaint handling and inspection procedures.
Qualifications:
- Bachelor’s Degree in a scientific field.
- 2-3 years of experience in the pharmaceutical industry (radiopharmaceutical experience preferred).
- Knowledge of FDA regulations and quality management systems.
- Strong technical writing and communication skills.
- Proficiency with Microsoft Office and quality management software.
- Ability to work effectively in a small team.
**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**
Salary : $72,000
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