QA Specialist - Night Shift

QA Specialist - Night ShiftLaboratoryUnion County , NJ, US

Added - 02/10/2024

Apply for JobOur client, a leading contract development and manufacturing organization (CDMO) based in the US, is seeking an Overnight QA Specialist to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts.Location: Union County, NJType: Direct HireResponsibilities

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.

Education and Qualifications

Bachelor’s Degree in a scientific discipline.

2-3 years of experience in the pharmaceutical industry

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

Experience with electronic quality management and laboratory information management systems.

INDBHLIDNPWe 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.