Job Description

Job Title: Quality Control Analyst II
Location: Cambridge, Massachusetts
Type: Contract
Compensation: $36 to $44/hr
Contractor Work Model: Onsite

Responsibilities
• Perform routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation
• Perform maintenance on complex laboratory equipment
• Participate in training of less experienced staff
• Participate in transfer methods from support groups to the QC laboratory
• May perform finished product review and lot release
• Perform cell culture, microbial, and/or molecular assays
• Coordinate departmental systems (i.e., inventory, documentation, equipment maintenance)
• Communicate inter-departmentally and with outside contacts to solve technical issues
• Exercise sound judgment and decision making when problem solving
• Revise standard operating procedures as needed
• Perform deviation and lab investigations as needed

Requirements
• Associate’s Degree plus a minimum 4-5 years relevant industry experience in CGMP lab environment or equivalent; Bachelor's Degree plus a minimum of 2+ years relevant experience; Master’s Degree plus 0+ years relevant experience
• Minimum of 1+ years in cell culture, microbial, and/or molecular assays
• Proficient in Outlook, MS Word, Excel, and lab-based data management systems (LIMs)
• Experience with microbiological testing, biological assays, or environmental monitoring
• Experience in a biotech, pharmaceutical, or other regulated industry
• Experience with PCR-based methodology or cell culture methods
• Knowledge of advanced microbiological techniques, disinfectant efficacy, microbial identification, rapid methods
• Ability to lift 40 lbs.
• Required to work one day per weekend
• Rotating holiday coverage
• May carry company issued cell phone for off-shift remote alarm coverage
• Required to gown into classified manufacturing ISO 7 clean room areas

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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