Senior Specialist 1, QA (Lot Review)
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Senior QA Specialist role supporting day-to-day Quality activities in accordance with approved SOPs/Policies for a large, multi-product, GMP biotech contract manufacturing facility.
QA oversight to Manufacturing process operations:
- Review completed GMP records to ensure compliance with cGMP per written procedures (eg manufacturing critical logbooks, batch records, changeover records)
- Review and approve SOP related to batch record/logbook review
- Participate and support improvement projects related to Manufacturing process operation
- Participate in walkthroughs and internal audit program
- In depth awareness of entire process; identifying operational factors which influence the process
- Plan for future activities and coordinate with other departments to complete the planned activities
- Make real-time decisions on process events on the floor based on knowledge of defined SOPs and policies
- Develop good working relationships with internal and external customers
Lot release (products):
- Compile batch documentation for lot release within targets defined by review and release schedule
- Review, approve changes to ensure compliance with cGMP
- Assessment of potential impact to product quality for open change request prior to lot release
Annual Product Review:
- Support timely completion of Annual Product Reviews
- Support training of new team members
- Work effectively with Program Management, site and customer as QA Project Lead for assigned projects
- Prepare responses for customer review observations
- Manage customer complaints
Implement ideas for system improvements and supporting as needed in the following:
- Customer and/or Regulatory Audits or meetings
- Any other duties assigned by Supervisor/Manager.
- Bachelor Degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
- Relevant QA Operations background from the Biopharma environment.
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Familiarity with Regulatory requirements and local Codes & Standards (e. g. , FDA, EMEA, andlCHQ7).
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and timelines.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieve ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.