Sterile Injectable Lab QA Specialist – Compliance & Oversight

Tailstorm-Health-Inc; Chandler (AZ); Presencial; USD 85.000 - 100.000; Jornada completa

Descripción de la vacante

Tailstorm-Health-Inc seeks a Laboratory Quality Assurance Specialist in Chandler, AZ to oversee chemical and microbiology QC activities in a sterile injectable manufacturing facility. You will review analytical data, CoAs, and reports to ensure data integrity and compliance with cGMP standards.

The role requires hands-on laboratory QA experience, strong documentation, and the ability to lead cross-functional teams through investigations, CAPAs, and regulatory inspections by US FDA and others.

Formación

• Bachelor’s or Master’s degree in Pharmacy, Science, Biotechnology, Microbiology, or related field.
• Experience with QA oversight in sterile injectable manufacturing.
• Ability to review analytical data, CoAs, and test reports.

Responsabilidades

• Provide QA oversight of Chemical QC and Microbiology QC lab activities in sterile injectable manufacturing.
• Review and approve analytical data, raw data, test reports, and CoAs for materials and products.
• Review data from HPLC, FTIR, UV-Vis, and other instruments, including chromatograms and audit trails.
• Review microbiological testing data including sterility, endotoxins, bioburden, and related tests.
• Plan and support audits and regulatory inspections, CAPA implementations, and investigations.

Conocimientos

QA Oversight

Lab QA

Analytical review

Documentation

Cross-functional

Educación

Bachelor’s/Master’s degree in Pharmacy or related field

Herramientas

HPLC

FTIR

UV-Vis

Liquid Particle Counters

Descripción del empleo

Tailstorm-Health-Inc seeks a Laboratory Quality Assurance Specialist in Chandler, AZ to oversee chemical and microbiology QC activities in a sterile injectable manufacturing facility. You will review analytical data, CoAs, and reports to ensure data integrity and compliance with cGMP standards.

The role requires hands-on laboratory QA experience, strong documentation, and the ability to lead cross-functional teams through investigations, CAPAs, and regulatory inspections by US FDA and others.