Microbiologist | Cary, NC

Detailed Information

  • Location: Morrisville, NC

  • Company: Intellectt

routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.

Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate. Function as a group lead, and provide technical guidance to junior analysts. To maintain awareness of c GMP's, industry standards, modern techniques and their application to medical sciences activities.

Author and/or revise procedures/methods, as appropriate. Perform technical review and verification of peers' analytical data in accordance with SOP's. Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.

Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented. Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities. Function as a back-up to the manager, as needed. Knowledge/Skills Requirements: Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs Ability

to learn and retain technical information Proactively address work issues at both an individual level and a team level Executes procedures or methods of moderate complexity with high quality Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Education & Experience: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR- Masters Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience

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