À propos
Qualified candidates must have: 3-5 years of Quality Assurance experience in the pharmaceutical industry or laboratory environment PREFERRED Excellent cGMP knowledge Strong organizational skills Microsoft Word and Excel proficiency Technical writing skills (be able to provide sample on request) Ability to work independently and as part of the team Science degree REQUIRED, preferably Chemistry Responsibilities may include: Analytical support/product development, formulation review, protocol approvals. Familiarity with CMC sections of abbreviated new drug applications Document activation and distribution: SOPs, specifications, protocols, etc. Analytical review: Must be able to review, interpret, and approve analytical reports Stability data: Interpret results, trend analysis, and approval of stability data Issuance and control of preventative maintenance documentation Lab audits Batch record maintenance and issuance Final batch record review, release, and pedigree issuance Support in various specialized software systems, such as Calibration program, documentation software, temperature monitoring, etc. Incident and investigation writing Technical support as needed Benefits include Medical, Dental paid time off and more! For details, please call Melissa at 815-997-1442
Compétences linguistiques
- English
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