Sterile Lab QA Specialist – Chemical & Microbiology

Medivant Healthcare; Chandler (AZ); On-site; USD 110,000 - 140,000; Full time

Job summary

Medivant Healthcare in Chandler, AZ seeks a Laboratory QA Oversight professional to provide QA oversight of Chemical and Microbiology QC in a sterile injectable manufacturing facility. You will review analytical data, raw data, CoAs, and stability studies, ensuring data integrity and compliance with cGMP and FDA expectations.

You will collaborate with cross-functional teams, support audits, CAPA implementations, and drive continuous improvement in environmental monitoring, investigations, and

Qualifications

• Strong knowledge of QC in sterile injectable processes.
• Experience overseeing chemical and microbiology labs.
• Excellent analytical and problem-solving abilities.
• Clear documentation and communication skills.
• Ability to lead cross-functional teams and prioritize tasks.

Responsibilities

• Provide QA oversight of Chemical QC and Microbiology QC in a sterile injectable manufacturing facility.
• Review CoAs, raw data, test reports, and analytical data across materials and products.
• Assess data from HPLC, FTIR, UV-Vis, LPCs and other instruments; review spectra and audit trails.
• Review microbiological testing data including sterility and bioburdens, endotoxins, and related tests.
• Prepare and review EM/PM plans, sampling locations and monitoring frequencies.
• Trend data, investigate CAPAs, and support contamination control and sterility initiatives.
• Support audits, regulatory inspections, and quality system improvements.

Skills

Quality Control

Laboratory oversight

Analytical skills

Documentation skills

Cross-functional leadership

Education

Bachelor’s/Master’s degree in Pharmacy, Science, Biotechnology, Microbiology, or related field

Job description

Medivant Healthcare in Chandler, AZ seeks a Laboratory QA Oversight professional to provide QA oversight of Chemical and Microbiology QC in a sterile injectable manufacturing facility. You will review analytical data, raw data, CoAs, and stability studies, ensuring data integrity and compliance with cGMP and FDA expectations.

You will collaborate with cross-functional teams, support audits, CAPA implementations, and drive continuous improvement in environmental monitoring, investigations, and