Quality Control Specialist, EM/UM (v765)

  • Contract Duration: 12+ months
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking to fill a contract role for a Quality Control Specialist with one of our global pharmaceutical clients. The position requires the candidate on-site in Boston, MA. This is a one-year contract with the possibility of extension.

This Quality Control Specialist provides testing support for the QC environmental monitoring and utilities monitoring (EM/UM) laboratory supporting oral dose and cell therapy GMP manufacturing facilities. Specific assigned persons are responsible for hands-on environmental monitoring and utilities sampling and testing while ensuring activities occur in an efficient and cGMP compliant manner.

KEY RESPONSIBILITIES of a Quality Control Specialist:

  • Collect, transport and process environmental monitoring of air, surface, personnel gowning, water, gas and steam systems samples according to established schedules or as requested with minimal supervision.
  • Perform microbiological (Bioburden) and chemical assays (Endotoxin, Total Organic Carbon, Conductivity, and Nitrates), related to clean room monitoring, utility monitoring independently following established methodology, procedures and SOPs.
  • Analyze organisms on cultured media from environmental monitoring and utility samples
  • Maintain accurate sampling and testing records and adhere to cGMP/GDP expectations
  • Participate in executing method validations and/or classified areas qualifications.
  • Troubleshoot microbiological and chemical methods with the assistance of supervisor when necessary
  • May be required to author and review data, procedures, microbiological and chemical methods, protocols, reports, deviations, and other quality records.
  • Participates in compliance related teams working towards the goal of continuous improvement.
  • Provide environmental monitoring and utilities monitoring guidance for training to junior staff or other departments.
  • Perform maintenance of instrument/ equipment calibration, temperature monitoring, reagent preparation, material and supply ordering and other general lab related responsibilities, as needed.
  • Assists in everyday organization of the EM/UM laboratory including safety, cleaning, maintenance and ordering of supplies.

REQUIRED EDUCATION LEVEL of a Quality Control Specialist:

  • A minimum of a Bachelor Degree in science (i.e., microbiology or related discipline) is required.

REQUIRED EXPERIENCE of a Quality Control Specialist:

  • 6+ years of relevant experience in GMP pharmaceutical/biopharmaceutical industry with at least 2 years of laboratory experience (microbiology and environmental monitoring preferred).

REQUIRED KNOWLEDGE/SKILLS:

  • Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections.
  • Strong knowledge of pharmaceutical microbiology methods and/or sterile techniques and applying/interpretation of GMP requirements. Expertise with bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc. on a variety of sample types, related to environmental and clean utilities monitoring is required.
  • Proficient in chemical assays (Total Organic Carbon, Conductivity, and Nitrates)
  • The ability to work well on a team in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.
  • Strong attention to detail, proactive, action oriented and can rapidly adapt to a change
  • Effective communication skills, both verbal and written, at all levels and across various functions.
  • Have hands on experience using and improving Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN)
  • Ability to work weekends and off-shift hours, as needed.
  • Ability to use Company vehicle to travel to RI location 2x a month.
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– The Lenox Executive Search Team