Lonza
At Lonza, we are proud to be a global leader in life sciences, with a commitment to continuous growth and innovative solutions. We invite you to join our dynamic Quality Compliance team as a Senior Quality Assurance Specialist. This pivotal role is your opportunity to make a significant impact within our CGT Organization by implementing and supporting robust Quality Systems.
As a Senior Quality Assurance Specialist, you will play a key role in ensuring adherence to all regulatory requirements while collaborating with various departments. You will have the chance to mentor your fellow team members and drive compliance with both federal regulations and company standards.
Key Responsibilities:
Review and approve initial and revised documents, including SOPs, Master Batch Records, Work Instructions, Test Methods, Specifications, Forms, and Checklists.
Evaluate and approve Validation/Qualification documents such as Protocols and Summary Reports for various systems and processes.
Assess non-DMS documents like Preventative Maintenance records, Instrument Data Sheets, and various facility forms for compliance.
Analyze document changes to determine impacts on regulatory and operational compliance.
Review and approve critical QMS processes including Deviations, CAPAs, Change Controls, Investigations, and Efficiency Checks.
Lead and facilitate meetings for DRB, CCC, and CAPA Boards.
Compile and analyze Quality metrics utilized as Key Performance Indicators for the Quality Council.
Conduct reviews and approvals for Lot Release activities, making informed lot disposition decisions.
Provide audit and inspection support, showcasing your expertise to facilitate successful outcomes.
Represent the QA team in meetings and on cross-functional project teams.
Actively mentor and train junior members of the quality team.
Key Requirements:
Exceptional written and verbal communication skills.
Detail-oriented with strong abilities in investigation and problem-solving.
Extensive experience reviewing and approving documents and protocols within Quality Systems.
Experience in leading and mentoring team members to ensure regulatory compliance.
Proven track record of compiling and analyzing Quality metrics effectively.
Ability to evaluate the regulatory and operational impact of document changes.
Join us at Lonza AG and be part of our mission to enhance the world with your expertise and dedication. This is your chance to thrive in a supportive environment while contributing to our shared success!
At Lonza, we are committed to ethical practices and respect for our people and the environment. We believe that our achievements are not only about results but how we achieve them.
Lonza embraces diversity and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic.