Lonza
Join Lonza, a global leader in life sciences, dedicated to making a positive impact across five continents. We are proud of our commitment to groundbreaking solutions and are looking for an ambitious Senior Quality Assurance Specialist to enhance our Quality Compliance team. If you are passionate about quality systems and regulatory adherence, this opportunity is perfect for you!
As a Senior Quality Assurance Specialist, you will play a critical role in ensuring continuous improvement throughout our organization. You will work collaboratively with various departments, mentoring others while driving adherence to federal regulations and company procedures. Your expertise will directly contribute to enhancing our Cell and Gene Therapy Organization.
Key Responsibilities:
Review and approve essential documents, including SOPs, Master Batch Records, Work Instructions, and Test Methods.
Evaluate Validation/Qualification documents for CIP, SIP, Equipment, and Computer Systems.
Assess and approve various non-DMS documents and forms, ensuring accuracy and compliance.
Analyze potential impacts of document changes on compliance and operations.
Lead key Quality Management System (QMS) processes, such as Deviations, CAPAs, and Change Controls.
Chair and lead meetings for DRB, CCC, and CAPA Board as required.
Compile and communicate Quality metrics for the Quality Council.
Oversee Lot Release activities and participate in lot disposition as necessary.
Provide support during audits and inspections as a Subject Matter Expert.
Represent the QA team in meetings and project teams effectively.
Mentor and train fellow quality team members to foster a culture of compliance.
Key Requirements:
Exceptional written and verbal communication skills.
Strong attention to detail with proven investigation and problem-solving abilities.
Experience in reviewing and approving documents within Quality Systems.
Ability to lead and mentor, promoting adherence to regulations.
Strong analytical skills for compiling and interpreting Quality metrics.
Adept at determining compliance impacts from document changes.
At Lonza, we believe every day is an opportunity to improve lives, and our team is at the forefront of this mission. If you are ready to make a meaningful difference and grow within a collaborative environment, we invite you to apply!
Lonza is an equal opportunity employer, ensuring all qualified applicants receive fair consideration.