Quality Assurance Supervisor - Night Shift

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

Quality Assurance Supervisor - Night Shift

United States, Houston (Texas)

Quality Assurance Supervisor – Night Shift

Location: This is an on-site position located in Pearland, TX.

Available shift: 5:00 pm to 2:00 am Monday through Friday

The Quality Assurance Supervisor - Night Shift will oversee quality assurance activities during the night shift (5:00 PM - 2:00 AM, Monday - Friday) at Lonza Houston Inc., ensuring compliance with all regulatory requirements and internal quality standards for the manufacturing of biopharmaceutical products. This role involves direct supervision of QA personnel and active participation in quality system management to maintain product integrity and safety.

What you will get:

This is a competitive, salary position. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.
• Shift differential (15%).
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• 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.

What we are looking for:

• Experience from 5 to 10 years in Quality Assurance within GMP-regulated environments.
• Minimum of Bachelor’s degree required in a scientific discipline (life sciences or engineering preferred).
• Previous leadership or supervisory experience, including managing teams and performance evaluations.
• Strong understanding of cGMP principles, regulatory requirements, and quality systems.
• Experience with deviations, investigations, CAPAs, and change control processes.
• Ability to work in a cleanroom environment and perform gowning requirements.
• Demonstrated ability to manage multiple priorities and lead cross-functional teams.
• Strong communication skills, including technical writing and stakeholder engagement.
• Experience with document control systems preferred.
• Knowledge of biologics, viral vectors, or cell and gene therapy manufacturing preferred.

About Lonza:

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R76457

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.