System One Quality Engineer II/III in Bedford, Massachusetts
Quality Engineer II/III
BS degree in relevant scientific discipline
3+ yrs. industry experience with quality systems and technical writing in pharmaceutical or biotech industry
Previous validation experience (equipment, computer system or process)
Good degree of knowledge in quality management systems
Has knowledge of GxP guidance relevant to role
Knowledge of FDA and international regulations
Technical Writing experience
Review and approve validation documentation: URS, validation plans, protocols, reports.
Review and approve R&D, MSAT and QC documentation for product progress.
Provide Quality Assurance (QA) review of exploratory and clinical batch records
Quality Assurance (QA) representative for project team(s).
Support cleaning validation and process / equipment validation including computerized system validation
Investigate exceptional conditions or deviations encountered during execution of validations, projects, regulatory requirements and analytical method activities.
Provide Quality Assurance (QA) review of procedures related to validation activities
Review equipment lifecycle forms and associated validation/calibration requirements for accuracy and completeness
Review & assess out of tolerance notifications and unscheduled maintenance work orders for impact on product, validation, calibration.
Perform other Quality Assurance (QA) duties as assigned.
Assist execution of all technical activities within quality assurance responsibilities.
Oversee technical activities within the quality systems.
Review and approve equipment/system qualification protocols and reports.
Review and approve Process Validation protocols and reports.
Review and approve Cleaning Validation protocols and reports.
Review and approve CSV protocols and reports
Location: Bedford, MA. area
Start Date: ASAP!
Duration: Direct Hire
Hours: Mon-Fri; 8am-4:30pm
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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