Employee Quality Control - Smoketown, PA, United States - Oceanic Ventures

James Miller

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James Miller

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Freelance
Description

Your Responsibilities:


  • Monitoring and planning of stability studies (according to ICH guidelines)
  • Creation of storage plans
  • Support in the evaluation of stability studies
  • Assistance in the preparation of stability reports in English (OGS and ICH research studies)
  • Coordination of internal and external storage and retrieval of test samples
  • Documentation creation/revision (forms, test protocols, general test instructions, SOPs)
  • Completion and filing of batch documentation
  • Revision, creation, and review of CoCs and CoAs
  • Data entry in LIMS

Your Profile:


  • Successfully completed vocational training as a chemical laboratory assistant, chemicaltechnical assistant, or equivalent qualification
  • Further training as a stability officer is advantageous
  • Experience in quality management (QS, QK, or laboratory)
  • Knowledge and experience in the GMP environment
  • Project management experience (desirable)
  • Experience with the European Pharmacopoeia (desirable)
  • Very good German language skills (spoken/written)
  • Good English language skills (spoken/written)
  • Proficient in MS Office
  • Experience with ERP systems (desirable)
  • Strong sense of responsibility and quality awareness
  • Proactive, independent, and structured way of working
  • Team and organizational skills
  • Resilience and flexibility

Why Us?:


  • Friendly colleagues
  • Small teams
  • Good worklife balance
  • Attractive compensation
  • Company pension plan and supplementary health insurance

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