Documentation Specialist

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Job description

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract opportunity to work as a Documentation Specialist located in Danvers, MA.

Shift: URGENT need,12 month contract, Part Time, shift flexibility (can work 20 hours, up to 40 hours, ideally 32 hours/4dayweek). *Potential for Temp-to-hire based on company circumstances for that year. This client is apart of a larger company. This could be a great opportunity to learn more about the IVD and Pharma industry, and even if the assignment does not end with a convert to a permanent role, there is always opportunity within the client's umbrella company.*

Pay: $43.50/hr

Job Description:

Documentation Specialists are responsible for supporting R&D documentation activities to fulfill program requirements for companion diagnostic assay development. The Documentation Specialist will be responsible for creating and revising quality management documents. In addition, the qualified candidate will assist R&D Scientists in the final formatting, approval, and release of the design controlled document for inclusion into a Design History File. A proven ability to communicate (verbal and written) and work with all levels of staff is fundamental to this role, and the qualified candidate must ensure all work is conducted in accordance with the established quality management system.

Responsibilities may include but not limited to:
• Generating SOPs, work instructions, document templates, and other project documentation for continuously improving, established processes
• Formatting of technical documents for standardization of design controlled documents that are released for stakeholder approval
• Editing of Quality Management System documents and maintenance of Quality records for revision control
• Working closely with R&D Scientists and Quality Assurance Specialists to ensure documentation deliverables are achieved in a timely manner through appropriate scheduling of work and communication on status of assigned tasks

Requirements:
• Ideal candidate has 2 to 4 Years industry experience preferably gained within an IVD and/or Pharma development environment
• Outstanding writing skills with advanced proficiency in the MS suite of products
• Ability to work in a regulated environment in which diagnostic assays are developed, commercialized, and supported (i.e. FDA QSR, ISO 13485, etc.)
• Good interpersonal skills with an ability to evaluate and concisely articulate scientific issues and contribute to the implementation of solutions
• Ability to prioritize multiple tasks and manage priorities, accordingly, demonstrating a sense of urgency for completing high priority tasks
• Capacity to work within a diverse team and be respectful of that diversity

APPLY TODAY FOR IMMEDIATE CONSIDERATION!

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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.

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 (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.

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