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QA Specialist

2 months ago

Union County, United States AstrixTechnology LLC Full time
Job DescriptionJob Description

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**

Company DescriptionSince 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.

Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.Company DescriptionSince 1995 Astrix has been delivering information technology consulting, regulatory advisory services and staffing solutions to the scientific community. We can assist in augmenting your internal resources to deliver optimum solutions on time and within budget. It is our goal to simply do it right. We work everyday to create value and build trust with our clients, employees, partners and vendors.\r
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Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.