QA Specialist III

Lonza Group Ltd.; Houston (TX); Presencial; USD 85.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive pay

Bonus

Health/Dental/Vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance program

Paid time off

Descripción de la vacante

Lonza is seeking a Quality Assurance Specialist III in Houston (onsite). You will ensure quality and compliance across aseptic manufacturing, partnering with Manufacturing, QC, Engineering and support teams.

You’ll guide investigations, review records and drive continuous improvement in a regulated GMP environment. The ideal candidate has at least 5 years in cGMP manufacturing, strong regulatory knowledge, and the ability to make critical quality decisions on the floor.

Formación

• Bachelor’s degree in a scientific/technical discipline.
• Minimum of 5 years in a cGMP manufacturing environment.
• Experience in pharma/biologics/GMP operations.
• Experience supporting investigations, deviations and root cause analysis.
• GMP knowledge incl. 21 CFR Parts 210, 211, 820; ISO data integrity preferred.
• Familiarity with aseptic manufacturing and cleanroom operations.

Responsabilidades

• Verify ISO, cGMP QA requirements and FDA regulations.
• Perform QA walkthroughs with Manufacturing to resolve issues.
• Provide independent quality oversight and decisions.
• Review Master Batch Records and GMP docs for releases.
• Support investigations, deviations, environmental monitoring and RCA.
• Offer QA support for aseptic manufacturing on the floor.
• Become gown-qualified and support on-floor QA in classified areas.
• Manage multiple projects and drive QA initiatives.

Conocimientos

Quality Assurance

Regulatory compliance

Investigation support

Batch record review

Cross-functional collaboration

Critical thinking

Educación

Bachelor’s degree in science/engineering

Herramientas

TrackWise

DMS

SAP

LIMS

Microsoft Office

Descripción del empleo

Quality Assurance Specialist III

Location: Houston, Texas – Onsite

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:

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

• A competitive compensation package.
• 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.

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. Join us. Be you.