Category: Life Sciences
Job Number: 19006
Position: QC Specialist or Senior Scientific Associate
Location: Boston, MA
Job Type: Contract
Duration: 12 months +
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 fostering our client’s vision
REQUIRED EDUCATION LEVEL:
- 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.
- A minimum of a Bachelor Degree in science (i.e., microbiology or related discipline) is required.
- 6+ years of relevant experience in GMP pharmaceutical/biopharmaceutical industry with at least 2 years of laboratory experience (microbiology and environmental monitoring preferred).
- 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.
Queen Consulting Group is an equal opportunity employer. Our goal is to promote an environment that helps our employees and clients appreciate the benefits that diversity provides.
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