QC Senior Specialist
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
This role provides a variety of analytical functions that occur in 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, testing, and reporting while ensuring activities occur in an efficient and cGMP compliant manner fostering the vision and values.
· 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, growth promotion, etc.) 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.
REQUIRED EDUCATION LEVEL:
· A minimum of a bachelor’s degree in science (i.e., microbiology or related discipline) is required.
· For a QC Sr specialist - A minimum of 5 years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred).
· For a QC specialist - A minimum of 3 years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred).
· For a QC Associate /Analyst - A minimum of 2 years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred).
· 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.
· This is a weekly second shift role 1-9:30pm (40 hrs /wk). A work week alternative of 4 days shifts (10hrs), Wed-Sat/ 1-11pm or Sun-Wed/ 1-11pm is also available upon agreement
Hourly Pay Rate: $50-$60/HR
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.