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QC Specialist / Sr. Scientific Associate

Boston, MA 02210

Posted: 01/17/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 533465 Is job remote?: No Country: United States

Job Description


Pay Rate Range: @$45/hr – some room there depending on experience

 

POSITION SUMMARY:

This role 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:

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

REQUIRED EXPERIENCE:
  • 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.
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