Senior Document Control Specialist - Hybrid Contract

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

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.