Sr. QA Specialist II

Lonza - Portsmouth, NH

Full-time - Mid Level

Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

The Senior QA Compliance Specialist 2 at Lonza AG plays a crucial role in ensuring compliance and quality assurance across various GMP operational areas in New Hampshire, USA. This position is integral to maintaining elite standards in life sciences, supporting the company's growth by adhering to regulatory standards and executing innovative processes.

Responsibilities

• Rotate daily through GMP operational areas to review GMP documentation and observe GMP work habits.
• Authorize the placement and removal of Quality Tag Outs.
• Respond to QA Hotline calls to support GMP operations.
• Provide GMP mentoring to Manufacturing, QC, Engineering/Facilities, and MSAT.
• Document all items within QAOTF shift notes and provide follow-up for other shifts as needed.
• Represent QA in meetings or on project teams.
• Identify standard methodologies and supply to the continuous improvement of QA processes.

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.

Nice-to-haves

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

Benefits

• Opportunity to work in a global leader in life sciences.
• Engagement in meaningful work that positively impacts millions of people.
• Support for career ownership and development.
• A collaborative and innovative work environment.