Senior Document Control Specialist

At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. We’re hiring a Senior Document Control Specialist for an opportunity in Santa Clara, California. With us, it’s all about finding the job that’s just right.

Senior Document Control Specialist
Santa Clara, California
Must be able to work onsite 3 days per week (hybrid)
1 year contract with potential to extend
Hourly pay: $45 – $55/hr +/- (based on experience) W2
Enhanced benefits (medical, dental, vision) + paid holidays & paid vacation

The Senior Specialist will play an important role in implementing the document and change control processes for changes to Documents and Records in Agile PLM system.

Responsibilities:

• Review changes in a timely manner for compliance with procedures.
• Select and/or verify required approvers of changes per procedures.
• Collaborate and provide feedback to change owners, approvers, and business partners as needed.
• Communicate the status of changes.
• Support and recommend change control process improvements.
• Ensure all activities adhere to the documented quality system and current regulatory requirements.

Required Skills & Qualifications:

• Minimum of a Bachelor's, equivalent University Degree required; degree in a science-related subject or other related field.
• Minimum 6 years of relevant work experience.
• Demonstrated experience in a Change Analyst role is required.
• Experience with a Product Lifecycle Management (PLM) system is required; Agile.
• Medical Device, Pharmaceutical, and/or Biotech experience.
• Demonstrated knowledge of electronic change control processes supporting a regulated industry.
• An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control, training, quality records, design control, and process control.
• Familiarity and ability to apply Good Manufacturing Practices (GMPs) documentation requirements, especially pertaining to quality records and change control.
• Proven experience/knowledge with managing parts/BOM structures/drawings.
• Proficient in Microsoft Suite (Outlook, Word, Excel, and PowerPoint).
• Ability to collaborate in an open office environment and remotely with virtual teams while paying attention to detail.
• Strong analytical, prioritization, communication, and leadership skills.

Desired Experience:

• Experience with MRP/ERP systems such as SAP.
• Experience in analyzing procedures.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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/Technology – Project Services?

Looking to work with leading project management organizations at top companies around the world? That’s where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world’s most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects—all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That’s just good planning.

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.

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