Sr QC Specialist-- Environmental Monitoring-- 2nd Shift

Title:  QC Senior Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type

• Job Location:  Boston MA
• Payrate: $50-60/hr
• Job#: bh15605

QC Senior Specialist
**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.