Quality Control Analyst
Mentor Technical Group
Metro, Puerto Rico, Puerto Rico
hace 28 días
  • Performs testing, sampling and inspection for raw materials / excipients, packaging components, intermediate products, retain samples, finished products and Inter Laboratory Qualifications as per current Testing Standards and / or monograph, USP, NF or validation protocols (where applicable).
  • Performs the disposition of raw materials / excipients, active product ingredients (API) and packaging components according to results obtained.
  • Performs investigations of non-conforming results and resolution of investigations.
  • Performs and reviews required testing of materials and products in accordance with product specifications and / or applicable compendia.
  • Processes and reports analytical data utilizing computer systems (e.g., Empower system, SAP, LIMS, etc.) and verifies data generated by other peers.
  • Operates laboratory equipment, such as : UV-Visible, FTIR, HPLC, GC, and others.
  • Qualifications :

  • Bachelor’s degree in Natural Sciences is required.
  • Minimum of 5 years of experience within Quality Control Laboratory in a regulated industry (pharmaceuticals, medical device, and / or biotechnology).
  • Working knowledge of computer and appropriate software packages. (e.g., Empower, LIMS and Microsoft Office (Word , Excel, Power Point).
  • Ability to perform basic troubleshooting, PM and / or calibration of laboratory equipments (column care and use, tools, in-line filters, etc.).
  • In-depth knowledge in the use and interpretation of USP / NF and a working knowledge of QC SOPs, cGMPs, federal and other countries regulatory requirements.
  • Ability to conduct a variety of analytical techniques.
  • Knowledge of cGMPs, EU and other regulatory requirements.
  • Proficiency in oral and written communication skills both English and Spanish.
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