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17 days old

Document Control Specialist

Kelly Services
Devens, MA 01434
We are seeking a Sr. Specialist for Document Control for our Cell Therapy Facility in Devens, MA. This individual will be responsible for executing the initiation, processing, routing, distribution, and archiving of cGMP records for the Devens CTF. The Sr. Specialist, Document Control role is stationed in Devens, MA and reports to the Senior Manager of Document Control for the Devens CTF.


+ Job Title: Document Control Specialist

+ Location: Devens, MA

+ Duration: 6 months

+ Rate: $48-53/hr.


**JOB RESPONSIBILITIES**


Executes the initiation, processing, routing, distribution and archiving of cGMP documentation and directs the compliance of Devens CTF documentation. Provides direction on the document change control business process for Devens CTF to stakeholders and customers. Ensures alignment of department procedures with global and site policies and procedures. Serves as a subject matter expert for the electronic document management system to internal and external clients. Assists in the development and review of Document Control-related procedures. Conducts user training on the electronic document management system and assists with onboarding of new personnel in regards to Document Control-related systems and processes. Provides direct Records Management support during regulatory agency inspections and corporate audits.


**QUALIFICATIONS AND EDUCATION REQUIREMENTS**


+ Knowledge of science generally attained through studies resulting in a **B.S., in science, engineering, biochemistry or related discipline** , or its equivalent is preferred.

+ A minimum of 4 years of relevant experience, direct document management experience in a regulated environment focused on product quality.

+ Knowledge of cell therapy, biologics manufacturing, or analytical testing is highly desirable.

+ Familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc. is required.

+ Excellent computer skills and knowledge of MS Office and Document Management systems is required.

+ Direct experience with, and technical knowledge of, the administration of an electronic document management system EDMS in a relevant industry.


**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 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-10 Expires: 2021-10-11

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Document Control Specialist

Kelly Services
Devens, MA 01434

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