Night Shift QA Supervisor – GMP & Compliance Lead

Lonza Group; Pearland, Northern (TX, KY); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Shift differential

Medical, dental and vision insurance

401(k) matching plan

Life insurance and disability

Job summary

Lonza Houston is seeking a Quality Assurance Supervisor for night shift to oversee QA activities on the 5:00 PM to 2:00 AM schedule. The role involves supervising QA personnel, ensuring cGMP compliance on the floor, reviewing batch records, deviations, and change controls, and leading investigations and audits.

The candidate will collaborate with Manufacturing, MSAT, Facilities, and Quality Systems, provide training, and support cleanroom activities in a highly regulated biopharmaceutical

Qualifications

• Experience from 5 to 10 years in Quality Assurance within GMP-regulated environments.
• Bachelor’s degree in a scientific discipline required (life sciences or engineering preferred).
• Strong understanding of cGMP principles, regulatory requirements, and quality systems.

Responsibilities

• Supervise and lead a team of QA personnel, including coaching, mentoring, and conducting performance evaluations.
• Provide QA on-the-floor (QAOTF) support for manufacturing operations and ensure compliance with cGMP requirements.
• Review and approve GMP documentation including batch records, deviations, change controls, CAPAs, and SOPs.
• Support and lead investigations, including deviations, OOS events, and corrective actions.
• Act as QA representative during internal and external audits and regulatory inspections.
• Collaborate cross-functionally with Manufacturing, MSAT, Facilities, and Quality Systems teams.
• Perform QA walkthroughs and provide real-time oversight of production activities to identify and resolve quality issues.
• Ensure training compliance and development of QA staff in alignment with site and regulatory requirements.
• Support gowning requirements (Level 3 / Grade B) and cleanroom activities as needed.

Skills

QA leadership

cGMP knowledge

Regulatory compliance

Audit support

CAPA management

Change control

Documentation review

Training & coaching

Gowning & cleanroom

Cross-functional collaboration

Education

Bachelor's degree in life sciences or engineering

Tools

Document control systems

Job description

Lonza Houston is seeking a Quality Assurance Supervisor for night shift to oversee QA activities on the 5:00 PM to 2:00 AM schedule. The role involves supervising QA personnel, ensuring cGMP compliance on the floor, reviewing batch records, deviations, and change controls, and leading investigations and audits.

The candidate will collaborate with Manufacturing, MSAT, Facilities, and Quality Systems, provide training, and support cleanroom activities in a highly regulated biopharmaceutical