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Description
Document Control Specialist – Denver, CO
Type: Contract (1-yr)
Shift: M-F 8a-5p
Pay Range: $30-$38/hr
Job Summary:
The Document Control Specialist is responsible for managing and overseeing document control systems that support the organization's processes, especially within a gMP/GLP environment. This role ensures that all corporate documents are well-maintained, easily accessible, and meet all regulatory and compliance requirements, including CFR and ISO regulations.
Key Responsibilities:
- Manage the document control system, ensuring that all documents are correctly filed, tracked, and maintained in compliance with regulatory requirements.
- Review and validate documents for accuracy and completeness, ensuring adherence to CFR and ISO standards.
- Develop and maintain document control databases and repositories.
- Assist with the preparation, review, and dissemination of controlled documents.
- Ensure compliance with internal and external regulations and standards, particularly those relevant to gMP/GLP environments.
- Coordinate the document review process and ensure documents are approved and distributed in a timely manner.
- Train staff on document control procedures and best practices.
- Provide support during internal and external audits, and assist in the preparation of audit reports.
- Conduct and document Corrective and Preventive Actions (CAPAs) and Out-of-Specification (OOS) investigations.
- Collaborate with various departments to ensure document control requirements are met.
- Maintain records of document reviews and revisions.
- Implement continuous improvement initiatives for document control processes.
Qualifications:
- Bachelor's degree in business administration, information management, or a related field.
- Proven experience in document control or a related role, particularly within a gMP/GLP environment.
- Proficiency in document management software and Microsoft Office Suite.
- Experience with external and internal audits and an understanding of audit processes.
- Knowledge of CAPAs and OOS investigations.
- Strong attention to detail and organizational skills.
- Excellent communication skills, both verbal and written.
- Ability to work independently and as part of a team.
- Extensive knowledge of regulatory requirements, including CFR and ISO standards.
- Project management skills and technical writing experience are a plus.
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® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.
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