Senior Document Control Specialist

Kelly Services; Santa Clara (CA); Hybrid; USD 128,943,000 - 157,597,000; Full time

Benefits offered by this job

Medical coverage

Paid holidays

Paid vacation

Job summary

Kelly Science, Engineering, Technology & Telecom (SETT) in Santa Clara, California, seeks a Senior Document Control Specialist to implement document and change control for Agile PLM changes. This on-site role anchors quality and regulatory compliance in a regulated industry.

The 1 year contract pays $45–$55/hr on W2 with enhanced benefits (medical, dental, vision) plus paid holidays and vacation. Candidates must have a BA/BS and 6+ years in a Change Analyst role with PLM experience.

Qualifications

• Bachelor's degree required in a science-related field or equivalent.
• Minimum 6 years of relevant work experience.
• Demonstrated experience as a Change Analyst is required.
• Experience with PLM systems; Agile methodology experience preferred.
• Experience in Medical Device, Pharmaceutical, and/or Biotech industries.
• Knowledge of FDA 21 CFR 820 and ISO 13485 documentation requirements.
• Understanding GMP documentation requirements for quality records and change control.
• Experience managing parts/BOM structures and drawings.
• Proficiency in Microsoft Office tools.

Responsibilities

• Review changes for timely compliance with procedures.
• Verify required approvers for changes per procedures.
• Collaborate with change owners, approvers, and partners as needed.
• Communicate the status of changes to stakeholders.
• Support and propose improvements to change control processes.
• Ensure activities adhere to quality systems and regulatory requirements.

Skills

Bachelor's degree

6+ years exp

Change analyst

PLM system

Agile

Medical device industry

FDA 21 CFR 820

GMP documentation

Parts/BOM management

Microsoft Office

Education

Bachelor's degree, science related

Tools

SAP

PLM system

Job description

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.

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