Laboratory Quality Assurance Specialist

Medivant Healthcare; Chandler (AZ); On-site; USD 85,000 - 100,000; Full time

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

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Laboratory Quality Assurance Specialist

Full Time Chandler, AZ, US

3 days ago Requisition ID: 1156

Salary Range: $85,000.00 To $100,000.00 Annually

Key Responsibility:

1. Laboratory QA Oversight – Chemical and Microbiology

• Provide QA oversight of Chemical QC and Microbiology QC laboratory activities in a sterile injectable manufacturing facility.
• Review and approve analytical data, raw data, test reports, and Certificates of Analysis (CoAs) for raw materials, in-process samples, finished products, and stability studies.
• Review analytical data generated using HPLC, FTIR, UV-Vis, Liquid Particle Counters, and other laboratory instruments, including chromatograms, spectra, calculations, and audit trails.
• Review microbiological testing data, including sterility, bacterial endotoxins, bioburden, microbial identification, growth promotion, and other applicable microbiological tests.

2. Environmental and Personnel Monitoring

• Prepare and review risk assessments, environmental monitoring (EM) plans, personnel monitoring (PM) plans, sampling locations, and monitoring frequencies.
• Review and trend viable and nonviable monitoring data, microbial recoveries, and alert/action limit excursions.
• Evaluate adverse trends, assess potential product quality impacts, and ensure appropriate investigations and CAPAs.
• Support contamination control and sterility assurance initiatives for aseptic manufacturing operations.

3. Laboratory Quality Systems and Investigations

• Review laboratory deviations, OOS/OOT results, atypical results, and data integrity issues. Ensure appropriate root cause analysis and CAPA implementation.
• Review and approve laboratory SOPs, specifications, analytical method validation/verification protocols, method transfer reports, and stability documentation.
• Review laboratory trends and support batch disposition, product quality assessments, and Annual Product Quality Reviews (APQRs).

4. Laboratory Equipment and Analytical Methods

• Review qualification, calibration, maintenance, and performance records for HPLC, FTIR, UV-Vis, Liquid Particle Counters, and other laboratory equipment.
• Ensure analytical methods are validated or verified, as applicable, and suitable for their intended use.
• Assess the impact of instrument failures, calibration issues, and analytical errors on laboratory results and product quality.

5. Audits and Regulatory Compliance

• Plan and conduct internal audits and laboratory self-inspections to assess compliance with cGMP, data integrity, and internal procedures.
• Conduct or support contract testing laboratory audits, review audit findings, and ensure timely CAPA closure and effectiveness verification.
• Support US FDA, state regulatory, and customer inspections, including laboratory readiness, documentation, and responses to observations.
• Ensure compliance with applicable US FDA regulations, USP standards, and pharmaceutical quality requirements.

Key Skills and Competencies:

• In-depth knowledge of Quality Control in sterile injectable manufacturing processes.
• Experience of laboratory oversight for chemical and microbiology.
• Strong analytical and problem-solving skills.
• Effective communication and documentation skills.
• Ability to manage cross-functional teams and prioritize tasks.

Education and Qualifications:

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