Connexion Systems + Engineering
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QC Senior Specialist - Boston MA - 18990
Boston MA, MA 02210 US
Posted: 05/09/2023
2023-05-09
2023-07-02
Industry: Scientific and Life Sciences
Job Number: 15605
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: QC Senior Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
**2nd Shift. Must have valid drivers license for travel 2-3 times/mo.
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:
REQUIRED EDUCATION LEVEL:
REQUIRED EXPERIENCE:
REQUIRED KNOWLEDGE/SKILLS:
Title: QC Senior Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 12 months, potential to extend
- Job Location: Boston MA
- Payrate: $50-60/hr
- Job#: bh15605
**2nd Shift. Must have valid drivers license for travel 2-3 times/mo.
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.
