Quality Assurance Specialist

Job DescriptionThe 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**Your Profile:*** 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 center 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.**Required Skills:**Accountability, Auditing, Compliance Reporting, Data Analysis, Detail-Oriented, Documentations, Environmental Monitoring Systems, GMP Compliance, Good Manufacturing Practices (GMP), Investigation Management, Process Improvements, Production Operations, Quality Assurance (QA), Quality Assurance Systems, Regulatory Compliance, SAP Quality Management (QM), Standard Operating Procedure (SOP), Supply Change Management, Systems Development Lifecycle (SDLC)**Preferred Skills:**Current Employees applyCurrent Contingent Workers apply**Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.**Employee Status:**Regular**Relocation:**No relocation**VISA Sponsorship:**No**Travel Requirements:**10%**Flexible Work Arrangements:**Hybrid**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**N/A**Job Posting End Date:**12/7/2025**\*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**
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