Quality Control Lead – Raw Materials

United States, Portsmouth (New Hampshire)

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.

Working independently, the QC Technical Lead assumes responsibility for QC documents, and supports technology transfer, validation, investigation support, and routine testing and projects. The Technical Lead’s knowledge of compendia (USP, EP, etc), computerized management systems, Microsoft Suite, and cGMP awareness equips them to support others within the team and QC. The Technical Lead will create documents that comply with the requirements of the Compendia (United States Pharmacopeia, European Pharmacopoeia and the Japanese Pharmacopoeia), and these documents will be revised within quality systems such as VCNs, Change Controls and CAPAs. The Technical Lead will manage Qualification Reports, and Product Quality Reports, as well as leading projects to meet established timelines.

Schedule for this position is Monday-Friday business hours

Key Responsibilities:

  • Process cGMP documents: Ensures documents conform to regulatory, industry, compendial and Lonza guidelines
  • Manage document change requests.  Creates new documents within the document management system (DMS), display a high comprehension of how DMS functions, and provide assistance to others using the program.
  • Writing – Quality Records (CAPA, Change Control, Investigations, Assessments)
  • Performs light laboratory work, as necessary
  • Performs data mining in electronic systems and interprets historical data
  • Participates in the requalification process for raw materials and authors reports
  • Projects – supports method transfers, new instruments, method qualifications
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations
  • Perform other duties as assigned

Key Requirements:

  • Minimum Associate's Degree required in Chemistry, Biochemistry, Biology or equivalent science field
  • 5+ years of previous experience working in a Quality GMP environment
  • Minimum 2 years of experience with change controls, CAPAs, VCNs, and investigations
  • Familiarity with compendia required
  • 2+ years of experience preferred with method verification transfer and validation (protocol and report generation, and bench/wet work)
  • Previous lab experience (ideally raw materials experience) preferred
  • Experience with document management systems (DMS)/document control practices and document change management
  • Experience in technical writing (protocols, reports, specifications and methods), including proofreading and editing
  • Coherent and effective interpretation of written and verbal instructions

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.

Reference: R54682
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