Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Location/Division Specific Information

Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.
You can find out more about our location in Weil am Rhein and Rheinfelden here: www.fisherclinicalservices.com

Discover impactful Work

As a Quality Assurance Specialist (m/f/d) at Thermo Fisher Scientific, you play a critical role in ensuring compliance, quality and operational excellence within a regulated GMP/GDP environment. You support quality systems, documentation control and secondary packaging quality oversight, contributing directly to patient safety, regulatory compliance and a strong quality culture across the site.

A Day in the Life

Perform maintenance, quality review and approval of TrackWise Quality Records, including Investigations, CAPAs and Change ControlsEnsure deviations and quality events are fully documented in compliance with GMP/GDP requirementsSupport root cause analyses and conduct effectiveness checks for CAPAsManage scheduling, coordination and communication for documentation reviews and approvalsProvide QA-related input to support project timelines and production planningMaintain accurate, complete and audit-ready QA documentationOversee execution of QC activities in Secondary Packaging, including Start-Up checks, In-Process Controls and Final ReleaseCoordinate with QC Team Leads when operational QC tasks are delegatedEnsure GMP/GDP compliance across all secondary packaging quality processesSupport and participate in self-inspections, client audits and regulatory authority inspectionsConduct and support QA Gemba walksReview, update and maintain SOPsAnalyse, report and track quality metrics to support continuous improvement initiativesProactively identify and escalate quality risks and propose mitigation actions to the Line Manager  

Keys to Success
Education:

Completed vocational training as PTA, MTA, CTA or a comparable qualificationAlternatively, a scientific background with relevant pharmaceutical experience

Experience:

Experience in the pharmaceutical industry, preferably in GMP QA or QCExperience within packaging and distribution environments is highly desirableSolid GxP knowledge gained through training or practical experienceExperience in root cause analysis and investigation report writing is an advantage

Knowledge, Skills, Abilities

Strong understanding of EU GMP requirementsProven ability to work in a structured, detail-oriented and compliant mannerProficiency in Microsoft Word, Excel, TrackWise and electronic document management systems (eDMS)Strong written and verbal communication skills and confidence working with cross-functional stakeholdersExcellent organisational and administrative skillsFluency in German and English (B2 level or higher, written and spoken)Strong team player with a proactive and quality-focused mindset

What we offer

Employment with an innovative, future-oriented organizationOutstanding career and development prospectsCompany pension scheme and other fringe benefitsExciting company culture which stands for integrity, intensity, involvement and innovation

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com 

Agency notice!
Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.