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Kelly Services Quality Specialist II in Cambridge, Massachusetts

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Quality Specialist II at a prestigious Fortune 500® company working in Cambridge, MA.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the “Submit Resume” button included within.

Job Title: Quality Specialist II

Pay: $105 per hour

Position Summary :

At Viral Vector Services (VVS) we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases

How will you make an impact?

The Quality Assurance Specialist II will support the quality systems team in Cambridge, MA. The Specialist will be responsible for evaluating, reviewing, and approving CAPAs or Change Controls. In this role, they will support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems.

What will you do?

  • Conduct QA assessments of product specific change controls, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker

  • Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations

  • Work with functional groups across the site to review and approve quality and technical documentation including: CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation.

  • Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities

  • May perform archiving duties in support of QA Document Control

  • Will perform data migration from paper systems to new electronic data systems.

Education, Experience

  • Bachelor's degree and 3 years of related work experience or Master’s degree and 1 year of work experience.

  • Preferred experience working in 2 or more functional areas

  • Minimum of 2 years in cGMP Quality Control operations in a fast-paced production environment

Knowledge, Skills, Abilities

  • Demonstrated ability collaborate across the business.

  • Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.

  • Demonstrated ability to present ideas persuasively and negotiate effectively

  • Excellent written and oral communication skills both internal and external.

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: ( .

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

Why Kelly ® ?

Kelly® Science & Clinical 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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. (