Quality Assurance Specialist IV - GMP Operations - Houston

About the role

Neurogene is seeking a Quality Assurance professional to assist in ensuring GxP compliance and quality oversight for the company's manufacturing operations. This role will collaborate across the company and support the filing of multiple investigational new drug applications. The selected individual will be a team player in a small company environment in this highly cross-functional role.

Responsibilities

• Review and approval of Quality System and cGMP documents, including SOPs, Batch records, protocols, and specifications
• Review and approval of change controls, non-conformances, OOS, deviations, complaints, and related items
• QA review and approval of manufacturing and QC related records, resolution of all related issues, and QA disposition of product batches
• Provide on-the-floor support during ongoing product manufacturing and testing
• Act as a lead for supporting manufacturing or QC methods projects
• QA review and disposition of raw materials, buffers, labels, and other components
• QA review and approval of initial qualification, validations, and re-validations for facilities, equipment, and processes
• QA oversight and review of QC qualifications and validations
• Responsible for generation, inspection, and release of labels
• Provide support and QA oversight of drug product shipments to clinical sites
• Maintain the company's controlled documents in accordance with GxP requirements
• Ensure escalation of quality issues to management as appropriate
• Assist in identifying and implementing process improvement opportunities to existing systems

Requirements

• Bachelor's degree in life sciences, pharmacy, or related engineering field
• At least 5-7 years of relevant experience in the biotech/pharmaceutical industry
• GMP and/or Quality certifications a plus

Skills

• Working knowledge of cGMP requirements for biologics manufacturing
• Working knowledge of requirements for aseptic manufacturing
• Basic knowledge of cell biology and cell culture
• Ability to work collaboratively in matrix organizations and teams
• Ability to interpret cGMP requirements
• Strong organizational skills and ability to manage and prioritize multiple projects
• Excellent communication skills
• Problem-solving skills and ability to make quality decisions based on technical facts and sound risk assessments

Work Environment

The role will involve working in office, cleanroom, and lab environments, with use of a laptop, or in meetings held in a conference room. Eyestrain and/or repetitive motion symptoms may occur due to extensive use of the computer.

Schedule

Full-time, days, with flexibility to attend meetings/calls and QA support of production activities. The role may include travel to meet vendors and attend conferences and meetings.