QA Specialist III-Raw Materials (Biotech)
Join Lonza AG as a QA Specialist 3- Raw Materials, and embark on an exciting career path where your contributions can make a global impact! This role is integral to our New Hampshire, USA location, where innovation and collaboration drive our success. As a QA Specialist, you will be part of a dynamic team dedicated to maintaining world-class standards in the pharmaceutical and biotechnology sectors.
Key responsibilities:
Edit and format cGMP specification documents, including raw materials and components information, ensuring detailed execution.
Apply your expertise in computerized management systems, Microsoft Suite, and cGMP to instruct and assist colleagues within QARM.
Process and format cGMP documents in-change efficiently and in an organized fashion.
Revise specifications within quality systems such as VCNs, Change Controls, and CAPA.
Participate in Tech Transfer Teams and learn regulatory expectations to review submissions.
Assist senior team members in reviewing regulatory submissions for sections requiring material reviews.
Own and lead Change Control and CAPA processes.
Key requirements:
HS Diploma or equivalent experience required; Bachelor's Degree or equivalent experience preferred.
3-5 years of proven experience in a similar role within the pharmaceutical or biotechnology industries.
Familiarity with computerized management systems and document management systems (DMS).
Strong proficiency in Microsoft Suite and awareness of cGMP standards.
Outstanding attention to detail and ability to work strictly within regulatory guidelines.
Proven track record to determine and successfully implement quality improvements.
Strong collaborative skills, with a dedication to contributing to a daring and inclusive team environment.
If you are prepared to compete at a high level and make a meaningful impact, we encourage you to apply for this outstanding opportunity at Lonza AG.
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 achievements 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. The satisfaction that comes with 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, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
