QA Specialist III (Mon-Thurs 11p-8a)

Lonza • Houston, TX

7d • Onsite

About The Position

The purpose of this role is to support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools. Supports corrective actions and change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management, and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance.

Requirements

• Bachelors in life sciences or engineering, or related field.
• GMP experience in the biologics and pharma industry.
• Working knowledge of equipment/facilities qualifications, GMP and GDP.
• Experience with regulations (US, EU, and other).
• Perform QA on the floor activities.
• Review batch records and QC TRF.

Responsibilities

• Verify the company’s compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate.
• Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs.
• Support activities that involve QA presence on the floor.
• Review Master Batch Records (MBR) and supporting documents to support batch disposition.
• Perform review/release of Buffer/ media as needed.
• Perform the Quality Assurance review and approval of GMP documents and Quality systems records.
• Prioritize and manage a variety of projects simultaneously.
• May need to lead and direct the work of others.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level