JobWatch

1+ months

Experienced Quality Assurance Specialist

Kelly Services
Burlington, MA 01805
Kelly Science & Clinical has a new **direct hire** opportunity for an experienced Quality Assurance Specialist with a global Biopharmaceutical company in Lexington, MA.



**Day-to-Day Responsibilities:**




+ Verify compliance according to Validation Master Plan requirements

+ Review of IQ, OQ, and PQ packages

+ Review unexecuted and executed batch records for compliance with internal specifications

+ Investigate manufacturing validation-related Deviations, Change Controls, Investigations, and CAPA

+ Review and approve document changes for SOPs, test methods, raw materials, protocols, and batch records

+ Performs internal and external audits

+ Train personnel to execute production according to GMP and Company quality system to ensure real-time compliance



**You are an excellent fit if you meet the following qualifications:**




+ BS in Life Science, required

+ 3-5+ years of QA manufacturing experience within Pharmaceutical, Biotechnology, and/or Medical Device Industries, required

+ Aseptic experience, highly desired

+ Working knowledge of 21 CFR, USP/EP monographs, Eudralex Vol 4, and GAMP 5, required

+ Proficiency in TrackWise, required

+ Excellent communication, presentation, and problem-solving skills

+ Ability to work independently in a cross-functional team environment



This position is Monday Friday from 8:00am 5:00pm. Salary will be based upon educational and Industry experience. If you, or someone you know, would be interested in this opportunity please apply online for immediate consideration.






**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-06-19 Expires: 2020-08-13

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Experienced Quality Assurance Specialist

Kelly Services
Burlington, MA 01805

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