Documentation Specialist

Kelly; Raynham (MA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Vacation and sick pay

Paid holidays

401(k) plan

Group medical, vision, dental, life, &

Short-term disability insurance

Job summary

Kelly is seeking a Documentation Specialist/Change Analyst in Raynham, MA to manage the Change Order process and ensure compliance with FDA QSR for Documentation and Documentation Control. You will release new and updated controlled documents, coordinate with Change Owners, and drive efficiency while maintaining compliance.

Excellent organizational and communication skills are essential in this role, with exposure to GMP/ISO environments.

Qualifications

• Bachelor degree preferred but not required.
• Minimum one year in GMP/ISO regulated environment required.
• Familiarity with PC-based viewing systems WebView, Product View, Agile.
• Windchill experience desirable.

Responsibilities

• Accountable for administration of the Change Order (CO) process.
• Ensure compliance with FDA QSR as it pertains to Documentation and Control.
• Release of new and changed controlled documents in a timely manner.
• Coordinate workflow with Document Control and Change Owners as needed.
• Maintain and improve processes for document management and compliance.

Skills

Documentation control

Quality/regulatory knowledge

FDA QSR compliance

Communication skills

Team player

Education

Bachelor degree preferred

GMP/ISO environment experience

Tools

WebView

Product View

Agile

Windchill

Job description

Description

Documentation Specialist
Kelly Services is currently seeking a Doc Specialist/Change Analystfor one of our top clients in Raynham, MA.
As a Change Analyst placed with KellyOCG you will be responsible for the following:

• Accountable for administration of the Change Order CO process.
• Accountable for compliance with the Food and Drug Administration s FDA Quality System Regulation QSR as it pertains to Documentation and Documentation Control.
• Accountable for the timely processing and release of new and changed controlled documents.

POSITION DUTIES RESPONSIBILITIES:

• Accountable that all Change Order s CO are reviewed for completeness, accuracy and compliance with applicable policies and procedures.
• Coordinate workflow and priorities of Document Control West Chester with management and Change Owners on an as needed basis.
• Communicate CO status information as requested.
• Administer the Periodic Review process for controlled Quality documents
• Manage Designated Alternate Signature forms
• Proactively seek methods of increasing efficiency while maintaining compliance in all areas of responsibility on a continuing basis.
• Provide historical and current documentation in response to queries from management and other departments as needed.
• Exhibit excellent organizational and communication skills.
• Properly employ all Synthes SOPs, Work Instructions, Training Guides, and Forms in the performance of tasks.
• Maintain a work environment that provides open communication and personnel growth.
• Be an extremely flexible team player, adaptable to change.
• Be customer service oriented and experienced at interacting with individuals at all levels, including upper management.
• Perform other special projects and support functions as assigned by the Manager of Document Management.
• Required to know and follow all laws and policies that apply to one s job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by supervisor or our Chief Compliance Officer.

EDUCATION EXPERIENCE REQUIREMENTS:

• Bachelor Degree is preferred, but not required.
• A minimum one year professional, intern or co-op in a GMP and/or ISO regulated environment is required.
• Familiarity with various PC-Based viewing systems WebView, Product View, Agile etc. is required.
• Windchill experience is desirable.

Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

Why Kelly?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG) is one focus within the full array of Kelly Services workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:

• Vacation and sick pay
• Paid holidays
• 401(k) plan
• Group medical, vision, dental, life, and short-term disability insurance options
• Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
• Kelly Learning Center offers free courses and trainings
• Weekly pay

About Kelly Services

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.