Quality Assurance Specialist II - 2nd Shift
Lonza•Houston, TX
•Onsite
About The Position
The Quality Assurance Specialist II represents the QA department to ensure quality and compliance requirements are met in support of manufacturing operations. This role provides QA oversight on the production floor, supports batch disposition activities, and collaborates with cross-functional teams to maintain cGMP compliance. The position also supports investigations, deviations, and change controls while ensuring timely and accurate review of GMP documentation in a fast-paced manufacturing environment.
Requirements
- 0–4 years of experience in Quality Assurance, Quality Control, or GMP-regulated manufacturing environment.
- Minimum of a Bachelor’s degree in a scientific discipline (Life Sciences or Engineering preferred).
- Working knowledge of cGMP, GDP, and regulatory standards.
- Strong communication and collaboration skills across cross-functional teams.
- Comfortable working in cleanroom environments and performing Level 3 gowning.
- Proficiency with documentation systems and standard office software.
Nice To Haves
- Experience reviewing batch records, QC documentation, and supporting manufacturing processes preferred.
- Familiarity with deviations, investigations, CAPA, and quality systems preferred.
Responsibilities
- Review and approve GMP documentation including batch records, QC testing records, and supporting documents for batch disposition.
- Provide QA oversight on the manufacturing floor, including walkthroughs, line clearances, and critical unit operations support.
- Perform QA walkthroughs and work closely with manufacturing and support groups to resolve quality issues.
- Ensure compliance with cGMP, ISO standards, and internal quality systems.
- Support deviations, CAPAs, change controls, and investigations using problem-solving tools.
- Maintain and track quality records to ensure audit readiness and timely completion.
- Support QA on-the-floor activities including Level 3 gowning (Grade B) for critical operations.
- Collaborate cross-functionally with Manufacturing, QC, Facilities, and Engineering teams.
Benefits
- Performance-related bonus (~7.5%) and shift differential.
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
