Document controller Jobs in Santa Clara, CA

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.

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