Scientist
System One
Job Title: Quality - Scientist
Location: Devens, MA
Hours/Schedule: 40 hours, Core hours are 9:00 - 4:00
Type: Contract
Overview
The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams.
Responsibilities
The subject matter expert for this position will be primarily required to:
• Qualify alternative raw material suppliers:
+ Work with procurement to identify new suppliers
+ Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing
+ Author technical equivalency assessments, specification comparisons and material characterization reports
+ Support risk assessments
+ Author change controls
• Additional Tasks would include:
+ Support material and consumable manufacturing investigations
+ Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
+ Support material specification development
Requirements
• Minimum BS/MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background.
• Awareness of cGMP compliance and regulatory agency requirements.
• Demonstrated problem solving ability (familiarity with root cause analysis techniques and CAPAs a plus)
• Strong organizational, oral communication and technical writing skills
• Effective team player and strong individual contributor
• Familiarity with analytical techniques (FTIR, SEM-EDS, etc.)
• Knowledge of data trending and tracking, including use of statistical analysis software a plus
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Ref: #558-Scientific
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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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