Laboratory Quality Assurance Specialist

Tailstorm Health Inc•Chandler, AZ

1d•$85,000 - $100,000

About The Position

The Laboratory Quality Assurance Specialist provides QA oversight of chemical and microbiology QC laboratory activities in a sterile injectable manufacturing facility. The role reviews analytical and microbiological testing data, environmental and personnel monitoring activities, laboratory quality systems, equipment and methods, and audit and regulatory compliance. It supports investigations, CAPAs, contamination control, sterility assurance, batch disposition, product quality assessments, and regulatory inspections.

Requirements

Bachelor’s or Master’s degree in Pharmacy, Science, Biotechnology, Microbiology, or a related field.
In-depth knowledge of Quality Control in sterile injectable manufacturing processes.
Experience providing laboratory oversight for chemical and microbiology laboratories.
Strong analytical and problem-solving skills.
Effective communication and documentation skills.
Ability to manage cross-functional teams and prioritize tasks.

Responsibilities

Provide QA oversight of chemical and microbiology QC laboratory activities in a sterile injectable manufacturing facility.
Review and approve analytical data, raw data, test reports, and Certificates of Analysis for raw materials, in-process samples, finished products, and stability studies.
Review analytical data and associated chromatograms, spectra, calculations, and audit trails generated using HPLC, FTIR, UV-Vis, Liquid Particle Counters, and other laboratory instruments.
Review microbiological testing data, including sterility, bacterial endotoxins, bioburden, microbial identification, growth promotion, and other applicable tests.
Prepare and review risk assessments, environmental monitoring plans, personnel monitoring 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.
Review laboratory deviations, OOS/OOT and atypical results, and data integrity issues; ensure appropriate root cause analysis and CAPA implementation.
Review and approve laboratory SOPs, specifications, analytical method validation and verification protocols, method transfer reports, and stability documentation.
Review laboratory trends and support batch disposition, product quality assessments, and Annual Product Quality Reviews (APQRs).
Review qualification, calibration, maintenance, and performance records for 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.
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.