QA Specialist / QA Specialistess

Quality Assurance Specialist - Quality Operations

Our Quality Assurance group is dedicated to ensuring that every material within our products is manufactured, processed, tested, packaged, stored, and distributed in accordance with our exceptionally high quality standards and all regulatory requirements. By collaborating with internal manufacturing facilities, external contract manufacturers, and suppliers, we have created a global manufacturing network that is committed to delivering a compliant and reliable supply to customers and patients on time, every time, across the globe.

Position Overview

The Specialist, Quality Operations in Schachen reports to the Associate Director of QA Operations and Compliance Biologics, supporting clinical quality activities at our Werthenstein site. The selected candidate will be accountable for Good Manufacturing Practice (GMP) compliance, ensuring that clinical supply functions operate within GMP requirements while providing compliant clinical drug substance and drug product supply. This role involves driving and supporting compliance-based programs and initiatives, which include leading cross-functional projects, addressing complex problems, driving current GMP quality initiatives, improving quality systems, managing compliance metrics, overseeing Standard Operating Procedures (SOP), and ensuring adherence to site procedures.

Key Responsibilities

• Demonstrate critical decision-making and project management skills.
• Participate in the release or rejection of GMP materials and components, providing direct batch release support or addressing critical program issues.
• Offer guidance and consultation on GMP and regulatory requirements or standards.
• Foster collaborative working relationships and effective communications with stakeholders across manufacturing operations, analytical testing, quality systems, and regulatory affairs at all levels.
• Oversee the investigation and resolution of deviations, utilizing root cause analysis techniques to ensure effective corrective and preventive actions are in place.
• Support, review and approve change management programs (Change Control) as necessary.
• Assist with equipment qualification, System Development Life Cycle (SDLC) activities, and environmental monitoring, in addition to supporting utilities functions.
• Conduct reviews and approvals of SOPs within Quality and relevant functional area procedures.
• Ensure all work is conducted to meet high standards of quantity, integrity, quality, and GMP compliance.

Your Profile

• A Master’s Degree in Engineering, Sciences, or a related field, coupled with at least five (5) years of experience in the pharmaceutical, biotech, or another regulated industry.
• Experience with formal problem-solving techniques and a hands-on approach, such as Root Cause Analysis and/or Lean Six Sigma tools.
• Familiarity with cGMP practices within a sterile, vaccine, bulk, or finished goods pharmaceutical environment.
• A solid understanding of Critical Process Parameters, Critical Quality Attributes, and general principles of equipment qualification.
• Experience with fully integrated, automated operations (e.g., DeltaV, SAP, MES).
• Knowledge of drug product filling and inspection practices.
• Fluency in English is required; proficiency in German is a plus.
• Demonstrated experience in technical writing, including investigations, laboratory reports, SOPs, batch records, or protocols.
• Ability to manage multiple investigations within established deadlines.
• Proven capability to handle numerous projects and initiatives concurrently.

About Our Company

Our company has been a presence in Switzerland since 1963, with a regional office and manufacturing/packaging facility in Lucerne, our operational hub. Approximately 1,000 employees collaborate across four locations in Lucerne (Tribschenstrasse, Citybay, Schachen, and Kriens). A fifth location in Zurich is focused on accelerating the development and commercialization of our medicines and vaccines, supporting our mission to save and improve lives worldwide.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe,” reflecting our commitment to our employees and the surrounding community.

Our Werthenstein BioPharma site in Schachen is where we carry out groundbreaking research, develop and analyze new biological agents, and produce clinical trial products for global clinical studies. The site hosts one of our global forensic laboratories, where we monitor our products through the supply chain to ensure safety and security for our patients.

Who We Are

Known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada, and MSD everywhere else, our company has been at the forefront of healthcare innovation for over a century, delivering medicines and vaccines for numerous challenging diseases. Our ongoing research endeavors aim to provide innovative health solutions that advance the prevention and treatment of diseases affecting both people and animals globally.

What We Look For

Imagine waking up each day with the opportunity to help save and improve lives around the world. Join us, and you can utilize your empathy, creativity, digital mastery, or scientific expertise in collaboration with a diverse team dedicated to providing hope to those battling significant health challenges.

We are proud to foster an inclusive environment that values diverse, talented, and committed individuals. Breakthrough innovations emerge from the collaborative efforts of diverse ideas, and we encourage our colleagues to challenge one another’s thinking and approach problems collectively. As an equal opportunity employer, we are committed to an inclusive and diverse workplace.

Apply online using the form below. Only applications matching the job profile will be considered.