21 days old

Senior Quality Assurance Specialist

Kelly Services
Burlington, MA 01805
Kelly Scientific is seeking a dire hire **Senior Quality Assurance Specialist** in **Burlington, MA** . This candidate will join a company that provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Senior Quality Assurance Specialist is an integral part of the companys Quality team, contributing to our success by providing quality oversight for client specific site validation programs, quality assessment of validation and quality investigations, providing routine on-the-floor QA presence for client specific processes, training manufacturing quality personnel for on the floor oversight, driving on time batch record reviews, and oversight to the manufacturing operation.


+ Responsible for working cross-functionally with Manufacturing, Process Engineering, Facilities, Inspection, and Project Management on Quality Assurance (QA) activities such as the following:

+ Quality oversight for validation (review of IQ, OQ & PQ packages)

+ Compliance to Validation Master Plan requirements

+ Manufacturing Quality Oversight (batch record review, quality approver for manufacturing deviations)

+ Quality Impact Assessment for Manufacturing and validation related Deviations, Change Controls, and CAPA

+ Driving Quality Metrics

+ Product Disposition

+ Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMPs and compnays quality system to ensure real-time compliance

+ Represent the companys quality assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented


+ Bachelors Degree in life science field; alternate field of study may be considered in combination with significant Aseptic Manufacturing industry experience

+ 6+ years of experience in Quality Assurance supporting manufacturing in Pharmaceutical, Biotechnology or Medical Device industry

+ Previous experience supporting on-the-floor activities for production facility

+ Strong facilitation and problem solving skills

+ Excellent written and verbal communication and presentation skills. Comfortable presenting information to management & peers

+ Comfortable working independently in combination with individuals in other departments across the organization

+ Strong working knowledge of PDA, FDA (21 CFR Part 210, 211, 600), EMA (Eudralex Volume 4), ICH, ISPE, USP/EP monographs, and GAMP 5 guidance

+ Proficient in Microsoft Office and TrackWise

This position is Monday - Friday from 8am - 5pm. Salary ranges from $80,000 to $90,000/year based on experience. The right candidate will start as soon as possible!

**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


Posted: 2020-06-17 Expires: 2020-07-23

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Senior Quality Assurance Specialist

Kelly Services
Burlington, MA 01805

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