Sr. QA Specialist II

Today, Lonza is a global leader in life sciences operating across five 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.

The Sr. QA Specialist 2 is a technical expert on the Quality Operations team. The Sr. QA Specialist 2 drives continuous improvement activities across CT to ensure the most robust compliance to all appropriate regulations. The Sr. QA Specialist 2 is an integral partner with Manufacturing Operations, mentoring and driving compliance to federal regulations and company procedures. The Sr. QA Specialist 2 supports Manufacturing Operations in driving Quality Systems (i.e. Deviations, Change Controls, CAPAs) adherence. Shift Schedule: 10hr W-Sa 8am-6:30pm.

Key responsibilities:

• Daily rotation through GMP operational areas for the review of GMP documentation and observation of GMP work habits
• Authorize placement and removal of Quality Tag Outs
• Respond to QA Hotline calls in support of GMP operations
• Provide GMP guidance to Manufacturing, QC, Engineering/Facilities and MSAT.
• Document all items within QAOTF shift notes, provide follow-up for other shifts as needed.
• Represent QA in meetings or on project teams.
• Mentor and train other quality team members.

Key requirements:

• Excellent written and verbal communication skills.

• Meticulous focus on detail and excellent investigation, problem-solving, and coordination abilities.

• Proven track record to work effectively with people, communicate negative information, and acquire positive results.

• Facilitate positive interdepartmental interactions with a diverse group of people, communicate needs and suggestions clearly, and listen attentively.

• Familiarity with SAP, TrackWise, DMS, and LIMS systems is an advantage.

• Flexibility to adapt to changing tasks while maintaining efficiency.

• Keep project leads and team members advised of the status of assigned work.

• Strong, diligent teammate with a positive proactive approach to drive projects/tasks to completion.

• Proficient in Microsoft Office applications.

• Effective negotiation skills to resolve differing perspectives.

• Accurately prioritize tasks and lead time optimally.

Education:

• Bachelor’s Degree required or equivalent experience in a related field

• 5-10 years of Quality Assurance experience

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 achieved 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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.