QA Specialist

Laboratory

Union County , NJ, US

• Added - 25/07/2024

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Our client is a rapidly growing radiopharmaceutical company looking for a QA Specialist to join their team! You'll be working in a state of the art facility in Springfield, NJ where they provide contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics.

Responsibilities

• Develop and implement plans for inspecting and testing incoming and outgoing products to ensure they meet quality standards and specifications.

• Oversee the handling and release processes for incoming production materials and site-manufactured drug products.

• Collaborate with production and quality teams to monitor, document, and report on quality metrics, including radiation, environmental, and health and safety goals.

• Write and revise documents and standard operating procedures; review investigations, analyze results, and provide technical conclusions aligned with quality risk management practices.

• Proactively identify potential risks, conduct root cause analyses, and implement preventive measures.

• Conduct internal and external quality audits, and prepare comprehensive reports of findings.

• Track and manage risk management processes, maintaining logs to highlight and report recurring issues to management and product development teams.

• Offer training and guidance to quality and production teams on systems, policies, procedures, and key processes.

• Investigate and analyze product complaints and quality issues, ensuring resolution according to company guidelines and regulatory standards.

• Update and refine company procedures for handling complaints and inspections to ensure accurate documentation and effective resolution.

• Support daily quality assurance activities and perform additional duties as required.

Education and Qualifications

• Bachelor’s Degree in a scientific discipline.

• 2-3 years of experience in the pharmaceutical industry, with a preference for radiopharmaceutical experience.

• Knowledge of FDA regulations and other relevant standards for finished pharmaceuticals.

• Excellent technical writing and communication skills.

• Experience with electronic quality management and laboratory information management systems.

• Proficiency in Microsoft Office and other relevant software applications.

• Ability to thrive in a small team environment and assume significant responsibilities early in the role.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.