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Compliance and Quality Assurance Manager

1 week ago

North Hampton, New Hampshire, United States Lonza Full time
Key Responsibilities
As a Senior QA Compliance Specialist - Operations, your primary responsibilities include:

- Rotating through GMP operational areas daily to review relevant documentation and observe work habits
- Authorizing the placement and removal of Quality Tag Outs
- Responding to QA Hotline calls to support GMP operations
- Providing GMP mentoring to cross-functional teams including Manufacturing, QC, Engineering/Facilities, and MSAT
- Documenting all items within QAOTF shift notes and ensuring proper follow-up for other shifts
- Representing QA in meetings and on project teams
- Identifying best practices to continuously improve QA processes

Main Requirements
To succeed in this role, you must possess the following skills and qualifications:

- Excellent written and verbal communication skills
- Meticulous attention to detail with strong investigation, problem-solving, and coordination abilities
- Proven experience in effectively communicating challenging information and achieving positive outcomes
- Ability to facilitate interdepartmental collaboration, clearly communicate needs, and listen attentively
- Familiarity with SAP, TrackWise, DMS, and LIMS systems is an advantage
- Flexibility to adapt to changing tasks while maintaining high efficiency
- Proactively keeping project leads and team members updated on the status of assigned work
- Strong team player with a positive, proactive approach to driving projects to completion
- Proficient in Microsoft Office applications
- Effective negotiation skills to resolve differing perspectives
- Ability to prioritize tasks accurately and manage time effectively

Education
You must hold a Bachelor's Degree and have 3-5 years of proven experience in a related field.