Quality Assurance Specialist IV

Lonza•Houston, TX

1d•Onsite

About The Position

The Quality Assurance Specialist IV serves as a senior quality representative supporting Cell Therapy manufacturing operations and associated support functions. This role provides Quality Assurance oversight for GMP manufacturing activities, quality systems, investigations, and documentation while ensuring compliance with cGMP regulations and company procedures. The position partners closely with Manufacturing, Quality Control, and Quality Systems teams to support production activities, review and approve quality records, drive issue resolution, and maintain a state of inspection readiness. The role also serves as a key quality resource for internal and external stakeholders while supporting continuous improvement initiatives and product quality objectives.

Requirements

Experience from 5+ years in Quality Assurance within a GMP-regulated biopharmaceutical, cell therapy, or related manufacturing environment.
Bachelor’s degree in Biology, Biotechnology, Life Sciences, Engineering, or a related scientific discipline is required.
Experience supporting GMP manufacturing operations is required.
Demonstrated experience with deviations, investigations, CAPAs, and change controls is required.
Knowledge of aseptic processing, cleanroom operations, and gowning requirements is required.
Strong understanding of cGMP requirements, FDA regulations, quality systems, and compliance expectations.
Experience reviewing and approving GMP documentation and quality records.
Strong technical writing, root cause analysis, risk management, and problem-solving skills.
Ability to work independently, prioritize multiple activities, and make sound quality decisions in a fast-paced manufacturing environment.
Strong communication and collaboration skills with the ability to effectively partner across multiple departments.

Nice To Haves

Experience in Cell Therapy manufacturing is strongly preferred.
Experience with TrackWise and electronic quality management systems is preferred.
Proficiency in Microsoft Office applications and quality-related systems such as Documentum, SAP, and LIMS is preferred.

Responsibilities

Perform Quality Assurance review and approval of GMP documents, including master documents, executed production records, deviations, investigations, CAPAs, change controls, and controlled documents.
Provide QA support and oversight for Cell Therapy manufacturing operations to ensure compliance with cGMP requirements and site procedures.
Conduct QA walkthroughs and on-the-floor quality oversight activities; partner with manufacturing and support groups to identify, investigate, and resolve operational issues.
Support deviation management, CAPA development, investigation activities, and change control processes as either record owner or QA approver.
Review and approve GMP documentation generated by Manufacturing, QC, Material Management, Facilities & Engineering, and other supporting departments.
Perform material release and lot disposition activities in accordance with approved procedures and quality requirements.
Represent Quality Assurance in internal and external client meetings to ensure quality expectations and regulatory requirements are met.
Track and manage quality system records to support timely closure and compliance objectives.
Support internal audits, customer audits, regulatory inspections, and inspection readiness initiatives.
Provide QA support regarding aseptic manufacturing activities, including gowning, cleanroom operations, and aseptic processing requirements as needed.
Collaborate cross-functionally with Manufacturing, QC, and Quality Systems teams to drive compliance, process improvements, and operational excellence.
Perform other duties as assigned.