Laboratory QA & Compliance Lead — Sterile Injectables

Medivant Healthcare

Chandler (AZ)

On-site

USD 85,000 - 100,000

Full time

2 days ago
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Job summary

Medivant Healthcare in Chandler, AZ seeks a Laboratory Quality Assurance Specialist to oversee QA activities in a sterile injectable manufacturing facility. The role involves reviewing analytical data, CoAs, and supporting quality systems across chemical and microbiology QC.

The position requires a Bachelor’s or Master’s in Pharmacy/Science/Biotechnology/Microbiology or related field, with experience in QA and regulatory compliance. On-site full-time role with competitive salary.

Qualifications

  • Bachelor’s or Master’s degree in Pharmacy, Science, Biotechnology, Microbiology or related field.
  • Experience with sterile injectable manufacturing QA systems is preferred.

Responsibilities

  • QA oversight of Chemical and Microbiology QC in sterile injectable manufacturing.
  • Review/approve analytical data, raw data, test reports and CoAs for materials, in-process, finished products, and stability studies.
  • Review data from HPLC, FTIR, UV-Vis, and other instruments including chromatograms, spectra and audit trails.
  • Prepare and review environmental and personnel monitoring plans, sampling locations and frequencies.
  • Lead audits and regulatory inspections readiness, ensure CAPAs and data integrity.

Skills

QA Oversight
Environmental Monitoring
Data Review
Regulatory Compliance
Analytical Skills
Cross-functional Collaboration

Education

Bachelor's/Master's in Pharmacy/Science/Biotech/Microbiology

Job description

Medivant Healthcare in Chandler, AZ seeks a Laboratory Quality Assurance Specialist to oversee QA activities in a sterile injectable manufacturing facility. The role involves reviewing analytical data, CoAs, and supporting quality systems across chemical and microbiology QC.

The position requires a Bachelor’s or Master’s in Pharmacy/Science/Biotechnology/Microbiology or related field, with experience in QA and regulatory compliance. On-site full-time role with competitive salary.

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