Quality Control Senior Specialist (v343)

Lenox Executive Search is seeking a Quality Control, Senior Specialist, for a 12 month contract position with one of our global pharmaceutical companies, working onsite in Boston, MA.

KEY RESPONSIBILITIES of a Quality Control, Senior 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
• Report OOT/OOS results and other deviations to area management.
• Review independently following established methodology, procedures, and SOPs
• Assist in troubleshooting of analytical microbiological and chemical methods with the assistance of supervisor when necessary
• Participate in executing method validations and/or classified areas qualifications.
• May participates in author and review data, procedures, microbiological and chemical analytical methods, protocols, reports, deviations, and other quality records.
• May participate in compliance related teams working towards the goal of continuous improvement.
• May 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.
• May provide environmental monitoring and utilities monitoring guidance for training to junior staff or other departments.
• Perform other laboratory duties as assigned.

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REQUIRED EDUCATION LEVEL of a Quality Control, Senior Specialist:

• A minimum of a bachelor’s degree in science (i.e., microbiology or related discipline) is required.

REQUIRED EXPERIENCE of a Quality Control, Senior Specialist:

• 6+ years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred). And 2 years in the lab

REQUIRED KNOWLEDGE/SKILLS of a Quality Control, Senior Specialist:

• Understand cGMP concepts and general practices.
• Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection.
• Knowledge of various laboratory equipment including Microbial ID systems, Chemical Analysis, pH meter, and balance. etc.
• 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
• Demonstrate good communication skills, both verbal and written, at all levels and across various functions.
• Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results
• Ability to work weekends and off-shift hours, as needed.