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Senior Specialist 1, Operations
2 weeks ago
Senior Specialist 1, Operations (Customer Project), QA
Today, Lonza is a global leader in life sciences operating across three 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 QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility .
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Daily company bus from the MRT location near your home to and from the Tuas site.
Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.
What you will do:
Act as the primary point of contact for QA-related topics for both customers and internal stakeholders.
Provide routine updates to customers on QA-relevant topics (e.g., weekly deviation updates).
Attend and contribute constructively in internal and external customer project meetings.
Coordinate and deliver product-specific documents (e.g., Quality Agreements, Product Quality Reviews, or similar reports) in a timely manner to meet customer satisfaction.
Coordinate and present quality reviews to internal stakeholders and customers as required.
Lead investigations for customer complaints and ensure records are closed in accordance with customer requirements and internal SOPs.
Provide QA oversight in customer project-related activities, including review and approval of product-specific documents or Trackwise records outside of routine operations, ensuring accuracy, timely delivery, and compliance with quality requirements. Examples include but are not limited to: PQR, sampling plans, control plans, process descriptions, BLA content, new product introductions, customer suspension/decommissioning, product recalls, and OOS records.
Provide QA Operations oversight to site-wide improvement projects.
Participate in and/or lead resolution of complex process or project issues.
Guide and coach junior members of the QA team.
Formulate and articulate solutions to issues/problems for internal/external teams and management.
Represent QA Operations in cross-functional decision-making meetings (internal and external).
What we are looking for
Degree/Diploma in Life Sciences, Biotechnology, Chemistry, or related discipline.
Relevant QA experience in the pharmaceutical, biotech, or related life sciences industry.
Strong understanding of cGMP requirements and QA processes.
Proven ability to manage customer interactions and deliver quality documentation in a timely manner.
Excellent problem-solving skills with the ability to resolve complex issues.
Strong communication and interpersonal skills to work effectively with cross-functional teams.
Experience in mentoring or coaching team members is an advantage.
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 results 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 — and 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, disability, veteran status, or any other characteristic protected by law.
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