QA Specialist

Vor 7 Tagen

Frankfurt am Main, Hessen, Deutschland Kymos Vollzeit


PROLYTIC

PROLYTIC ist ein wissenschaftlich-technisches Dienstleistungsunternehmen, das sich an biotechnologische und pharmazeutische Unternehmen richtet. Wir bieten ein breites Spektrum an analytischen Dienstleistungen in den Bereichen Bioanalytik, Pharmakokinetik, Pharmazeutische Analytik und RNA/DNA-Analytik, von der präklinischen und klinischen Entwicklung bis zur Vermarktung von verschiedenen Arzneistoffen an.



Stellenbeschreibung

Prolytic GmbH | Part of the Kymos Group

About Prolytic / Kymos Group

Prolytic GmbH is a specialized GLP-certified bioanalytical laboratory and has been part of the Kymos Group since 2020. The Kymos Group is a leading international CRO providing analytical and bioanalytical services to support drug development from preclinical stages to market authorization.

To strengthen our Quality Assurance team, we are looking for a motivated QA Specialist (m/f/d) to join us at the earliest possible date.

Your Responsibilities

  • Maintenance and continuous improvement of the GLP quality system
  • QA review and approval of study plans, raw data, and final study reports
  • Handling of deviations, OOS/OOT investigations, and follow-up of CAPAs
  • Preparation, review, and maintenance of SOPs and quality-relevant documentation
  • Planning, conduct, and follow-up of internal audits and of customer and regulatory inspections
  • Training of staff in GLP and QA-related topics
  • Close collaboration with bioanalytical departments and the QA teams within the Kymos Group

We Offer

  • A responsible and varied position in an established GLP-certified bioanalytical laboratory
  • Integration into an international CRO group with development and career opportunities
  • Opportunity to work on innovative drug development programs for international biotech and pharma clients
  • Flat hierarchies and short decision-making processes
  • A collaborative and scientifically driven working environment
  • Flexible Working hours / flextime
  • Good accessibility by car and public transportation
  • Free drinks (coffee, tea, water)
  • Company medical care
  • Competitive salary and benefits package

Interested?
We look forward to receiving your application and getting to know you.



Anforderungen

Your Profile

  • University degree in a life science discipline (e.g. Biology, Chemistry, Biochemistry) or a comparable qualification
  • Professional experience in Quality Assurance within GLP and sound knowledge of GLP regulations
  • Knowledge of GMP-regulations desirable
  • Structured, detail-oriented, and independent working style
  • Strong communication skills and a collaborative mindset
  • Very good command of German and English

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