QC Microbiology Supervisor

Published: October 25, 2018
Location
South Carolina, United States
Job Type
Category
Job Code
23072
Years of Experience
7
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

  • Supervise Microbiology Laboratory
  • Oversee and conduct USP and EP microbiological analyses of raw materials, finished products, and environmental monitoring samples to include:
  • OOS/Atypical results investigations.
  • Troubleshooting Microbiological Methods application.
  • Troubleshooting laboratory instrumentation.
  • Train, coach, and mentor Microbiological staff.
  • Write and cross-validate microbiological test methods for new and existing raw materials and finished products.
  • Write Microbiology Laboratory Standard Operating Procedures (SOPs), trending reports, qualification protocols, method suitability reports, Aiken Bio-safety requirements, etc., that adhere to Corporate quality standards, Pharmacopoeia, and FDA guidelines.
  • Provide and execute Performance Qualification support for plant utilities (i.e., USP Water, Nitrogen, Compressed Air, HVAC).
  • Oversee the complete and scientifically sound resolution of out-of-specifications and atypical results.
  • Troubleshoot and resolve issues relating to microbiological methods, processes, or equipment.
  • Write and execute laboratory equipment qualification protocols (e.g., refrigerators, water baths, incubators, autoclaves, etc.)
  • Review raw data, testing frequency, quality control specifications, and pharmacopoeial procedural revisions for correctness, compliance, and accuracy.
  • Support Health Autories Audits (i.e FDA, EMA, MRHA, CAG, etc.)

 

Requirements

  • Bachelor’s Degree in Biology, Microbiology or related field.
  • Minimum of 7 years’ experience in cGMP Laboratory environment, preferably as SME role
  • Microbiology Subject Matter Expert (SME)
  • Leadership
  • Flexibility
  • Self-motivation
  • Ability to manage multiple priorities
  • Expertise in the use and operation of computers and related software (e.g., MS Office, LIMS, SAP)
  • Take proactive measures to achieve goals
  • Knowledge of cGMPs relating the QC Laboratory
  • Working knowledge of particle counters, air sampling equipment, laboratory bio-safety, Quality Management standards, and GMP requirements.
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