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

lonza

Houston, TX

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JOB DETAILS
SKILLS
Biology, Change Control, Corporate Compliance, Corrective Action, Dental Insurance, Employee Assistance Plan, Equal Employment Opportunity (EEO), Establish Priorities, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Manufacturing, Manufacturing Management, Manufacturing Operations, Materials Management, Medical Products, Multitasking, Operational Support, Problem Solving Skills, Production Support, Quality Assurance, Quality Control, Quality System Requirements (QSR), Regulations, Safety Standards, Vision Plan
LOCATION
Houston, TX
POSTED
4 days ago
QA Specialist III (3rd Shift, Monday-Thursday)

Location: This is an on-site position located in Pearland, TX

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

Shift: Third Shift: Monday-Thursday 11p-8a.

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.

What you will get:

A competitive compensation. 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 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.
What we are looking for:
  • 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.


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 help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

About the Company

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lonza