Quality Assurance Specialist (m/f/d)
Bewerben
remote type
Not Applicable
locations
CHE - Schachen - Werthenstein
time type
Vollzeit
posted on
Vor 2 Tagen ausgeschrieben
time left to apply
Enddatum: 10. September 2025 (Noch 11 Tage Zeit für Bewerbung)
job requisition id
R361358
Stellenbeschreibung
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
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, ensuring clinical supply functions operate 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:
- Apply critical decision making, project management skills.
- Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
- Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
- Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
- Ensure 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.
- Perform SOP review and approval within Quality and for functional area procedures.
- Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.
Your Profile
- A Master’s Degree in Engineering, Sciences or related field and 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 to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools
- cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
- Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
- Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES.
- Experience in drug product filling and inspection practices.
- Fluent in English and German a plus.
- Experience in pharmaceutical, biotech or other regulated industry.
- Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
- Ability to conduct multiple investigations within established deadlines.
- Demonstrated ability to manage multiple projects and initiatives.
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.
Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE
Current Contingent Workers apply HERE
Personalberatungsvertreter, bitte sorgfältig lesen
Merck & Co., Inc., Rahway, NJ, USA, auch als Merck Sharp & Dohme LLC, Rahway, NJ, USA, bekannt, akzeptiert keine unaufgeforderte Unterstützung von Personalvermittlungsfirmen. Alle Lebensläufe, die von Personalberatungen an einen Mitarbeiter unseres Unternehmens gesendet werden, ohne dass eine gültige schriftliche Vermittlungsvereinbarung für diese Position besteht, gelten als alleiniges Eigentum des Unternehmens. Im Falle der Einstellung eines Bewerbers durch unser Unternehmen in Folge einer Agenturempfehlung wird keine Gebühr entrichtet, sofern keine entsprechende vorherige Vereinbarung besteht. Wenn Vereinbarungen mit der Agentur vorhanden sind, sind die Einführungen positionsspezifisch. Bitte keine Anrufe oder E-Mails.
Mitarbeiter-Status:
Fest angestellt
Umzug:
No relocation
Visa-Sponsoring:
No
Reiseanforderungen:
10%
Flexible Arbeitszeitvereinbarungen:
Not Applicable
Schicht:
Not Indicated
Gültige Fahrerlaubnis:
No
Gefahrstoff(e):
N/A
Required Skills:
Betriebsprüfung, Betriebsprüfung, Change Management, Compliance-Berichterstattung, Compliance-Überwachung, Datenanalyse, Detailorientiert, Einhaltung der GMP-Richtlinien, Fertigungsbetrieb, Gute Herstellungspraxis (GMP), Implementierung von Richtlinien, IS-Revision, Juristische Dokumentenprüfung, Lean Six Sigma (LSS), Personalführung, Pharmazeutische Industrie, Problemlösung, Prozessverbesserungen, Qualitätsmetrik, Qualitätssicherung (QA), Qualitätssicherungssysteme, Regulatorische Compliance, Schulung und Entwicklung, Standardarbeitsanweisung (SOP), Standard Operating Procedure (SOP) Management {+ 4 weitere}
Preferred Skills:
Änderungskontrollen, Chargenprotokollprüfung, Master Batch Records, Six Sigma
Job Posting End Date:
09/10/2025
*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.
