Quality Assurance Specialist

Quality Assurance Specialist (m/f/d) Werthenstein BioPharma GmbH Vacant since : 14.11.2025 Number of jobs : 1 6105 Schachen LU (LU) 100% Immediately Permanent Registration requirement The Specialist, Quality Operations Schachen reports to the Associate Director, QA Operations and Compliance Biologics and supports clinical quality activities at our Werthenstein site. The successful candidate will have accountability for Good Manufacturing Practice (GMP) compliance within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management, and site procedures. Responsibilities Conduct quality review and approval of GMP documentation (e.g. calibration activity documentation, equipment periodic review, logbooks, raw materials) Quality oversight activities under the responsibility of the Quality Operations area Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues Contribute that deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions Support, review and approve as needed the change management program (Change Control) Provide guidance and support on equipment qualification, System Development Life Cycle (SDLC), activities, environmental monitoring, as well as support of utilities functions Oversight and coordination of supplier management, including approval of suppliers, coordination of supplier change notifications, and support in management of site-relevant Technical & Quality Agreements Perform SOP review and approval within Quality and for functional area procedures Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance Qualifications A Bachelor’s Degree in Engineering, Sciences or related field and at least three (3) years of experience in the pharmaceutical, biotech or another regulated industry Knowledge of quality oversight requirements for management of suppliers Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification Experience with formal problem-solving techniques and a hands‑on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES Experience in conducting quality oversight activities on manufacturing operations and analytical testing Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols Demonstrated ability to manage multiple projects and initiatives Proficient IT acumen Excellent communication skills and fluency in English and German Quality and Compliance oriented mindset The Company Our Company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the centre of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us. Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients. Additional Information Relocation: None Visa Sponsorship: None Travel Requirements: 5% Flexible Working Arrangements: None specified Shift: No Valid Driver License: No Hazardous Materials: No Work Details Work location: 6105 Schachen LU (LU) Workload: 100% Employment start: Immediately Employment duration: Permanent Qualification: skilled Work experience: More than 3 years Education: Bachelor’s degree from a university of applied sciences or equivalent German (Orally): Very good knowledge; Written: Very good knowledge English (Orally): Very good knowledge; Written: Very good knowledge By email: sophie.knivett@msd.com #J-18808-Ljbffr