Quality Control Analyst Environmental Monitoring GMP Manufacturing

Position Overview

The QC Analyst in Quality Control, Environmental Monitoring will be responsible for tasks related to environmental monitoring, aseptic processing, and microbial control at Neurogene's Houston GMP manufacturing facility. This role will also support testing associated with intermediate and finished product stability studies.

Requirements

• Establish environmental sampling maps for defined clean room areas
• Performed compressed gas testing in clean rooms
• Revise SOPs, material specifications, and work instructions as determined by Sterility Assurance Manager
• Participate in daily, weekly, and monthly monitoring of the cleanroom environment
• Obtain training on operation of the MODA Environmental Monitoring (EM) data collection system
• Perform EM validation activities as required
• EM sampling of GMP Cleanroom suite during at-rest and in-operation activities
• Schedule water system and clean steam sampling and testing
• Prepare trending and technical reports
• Establish alert and action limits based on statistical analysis of environmental data at rest and in operation
• Investigate and recommend corrective actions for environmental excursions
• Obtain training in microbiological techniques and procedures
• Obtain training to qualify Manufacturing staff in aseptic techniques
• Maintain aseptic process validation and operator qualification programs
• Support Manufacturing during aseptic processing simulation activities
• Support batch and raw material testing including growth promotion, bioburden, and endotoxin testing
• Other activities as defined by the Sterility Assurance Manager and Senior Director of Quality Control

Essential Job Details

• Work Schedule: Full time, day shift
• Travel: N/A
• Safety: Knowledgeable and complies with all pertinent safety policies, rules, and regulations.
• Quality Responsibility: Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures, and instructions for all activities in which the team participates.

Minimum Requirements

• Education: BA or BS degree in Biology, Biotechnology, or related science field
• Experience: Minimum 2 Years of Quality Control Experience
• Knowledge, Skills & Attributes: Working knowledge of GMP/GLP operations, understanding of typical QC instrumentation, experience with environmental monitoring, raw material testing, etc., ability to perform final fill inspections, time management skills, record keeping skills, organizational skills, good aseptic technique, self-starter with high degree of energy, independence, initiative, and self-motivation, passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.