Planet Pharma
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http://www.theplanetgroup.com
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QC Senior Specialist
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Posted: 06/01/2023
2023-06-01
2023-07-07
Employment Type:
Contract
Job Category: Scientific
Job Number: 564287
Is job remote?: No
Country: United States
Job Description
SUMMARY
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.
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, 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.
REQUIRED EXPERIENCE:
· 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).
REQUIRED KNOWLEDGE/SKILLS:
· 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
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.
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, 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.
REQUIRED EXPERIENCE:
· 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).
REQUIRED KNOWLEDGE/SKILLS:
· 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
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