QA Specialist III

Lonza; Houston (TX); Híbrido; USD 85.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance and disability

Employee assistance programs

Paid time off

Descripción de la vacante

Lonza is seeking a Quality Assurance Specialist III to ensure quality and regulatory compliance across aseptic manufacturing operations. You will partner with Manufacturing, Quality Control, Engineering, and support teams to safeguard product quality and patient safety.

You will review Master Batch Records, support investigations and deviations, and drive continuous improvement within a GMP framework. A strong QA mindset, cross-functional collaboration, and meticulous documentation are essential.

Formación

• Bachelor’s degree in a scientific, technical, engineering, or related discipline required.
• Minimum 5 years in a cGMP-regulated manufacturing environment with QA experience.
• Experience reviewing GMP docs, batch records, and deviation records with attention to detail.
• Familiarity with aseptic environments and cleanrooms; strong regulatory knowledge.

Responsabilidades

• Verify ISO, cGMP, FDA/regulatory requirements compliance.
• Perform QA walkthroughs with Manufacturing to identify and resolve issues.
• Provide independent quality oversight and make quality-related decisions.
• Review and approve Master Batch Records and GMP documentation.
• Support investigations, deviations, environmental monitoring, and root cause analysis.
• Provide QA support for aseptic manufacturing and on-floor decision making.
• Become gown-qualified for on-floor QA in classified environments.
• Manage multiple projects while supporting quality system initiatives.

Conocimientos

Quality assurance

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

Educación

Bachelor’s degree in science/engineering

Herramientas

TrackWise

DMS

SAP

LIMS

Descripción del empleo

Shift: Sunday through Thursday, 8:00 AM - 5:00 PM

As a Quality Assurance Specialist III, you will serve as a key representative of the Quality Assurance organization, ensuring quality and compliance standards are maintained across aseptic manufacturing operations. This role provides the opportunity to partner closely with Manufacturing, Quality Control, Engineering, and support teams to support production activities, provide quality oversight, maintain cGMP compliance, and help deliver life-changing therapies to patients. The successful candidate will be responsible for quality decision-making, investigation support, batch record review, and driving compliance initiatives within a regulated GMP manufacturing environment.

What you will get:

A competitive compensation package. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus
• 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:

• Verify compliance with ISO, cGMP quality system requirements, FDA regulations, and other applicable regulatory guidance.
• Perform QA walkthroughs and work closely with Manufacturing and support groups to identify, investigate, and resolve quality and compliance issues.
• Provide independent quality oversight and make quality-related decisions based on regulatory and compliance knowledge.
• Review and approve Master Batch Records (MBRs), executed batch records, and supporting GMP documentation to support manufacturing operations and product release activities.
• Support and oversee investigations, deviations, environmental monitoring events, laboratory investigations, and root cause analysis activities.
• Provide quality support for aseptic manufacturing operations, including real-time decision making during production activities.
• Become gown-qualified and provide on-floor QA support within classified manufacturing environments.
• Manage multiple priorities and projects simultaneously while supporting quality system initiatives and continuous improvement efforts.
• Lead or support special projects and additional QA compliance activities as assigned by QA leadership.

What we are looking for:

• Bachelor’s degree in a scientific, technical, engineering, or related discipline required.
• Minimum of 5 years of experience in a cGMP-regulated manufacturing environment and related Quality Assurance field.
• Previous Quality Assurance and/or Quality Control experience within pharmaceutical, biologics, cell therapy, or GMP manufacturing operations.
• Experience supporting investigations, deviations, root cause analysis, and quality system processes.
• Knowledge of GMP regulations, including 21 CFR Parts 210, 211, and 820, as well as ISO quality standards and data integrity requirements preferred.
• Familiarity with aseptic manufacturing environments and cleanroom operations.
• Experience reviewing GMP documentation, batch records, and deviation records with strong attention to detail.
• Strong critical-thinking skills with the ability to make independent quality decisions in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office applications; experience with TrackWise, DMS, SAP, and LIMS systems preferred.
• Strong communication, technical writing, time management, and cross-functional collaboration skills.
• Ability to manage multiple projects concurrently while maintaining a high level of quality and compliance.

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 make a meaningful impact by supporting quality and compliance excellence in a GMP manufacturing environment, we look forward to welcoming you on board.

Reference: R80105

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.