Quality Assurance Expert MEWPJP
Job Title: Associate Quality Systems Specialist
Location: 6600 Sierra College Blvd, Rocklin, CA 95677
Contract Type: W2 Contract
Contract Period: April 21, 2025 - February 27, 2026
Work Schedule: 100% On-site
Pay Rate: $26.00 - $27.00/hour
Note: The Rocklin site is scheduled to close in February 2026
Position Summary
The Associate Quality Systems Specialist will join the Quality team and provide operational support for the Quality Management System (QMS) at the Rocklin, CA site. This entry-level role is crucial in maintaining compliance with various regulatory requirements including ISO 13485, MDSAP, IVDD/IVDR, 21 CFR, and GxP. It involves performing documentation reviews, quality audits, cross-functional collaboration, and supporting both current and future product documentation needs.
This is a great opportunity for someone with at least 1 year of experience in a GMP/Pharma setting, who is detail-oriented, energetic, and eager to learn and grow in the quality assurance field.
Ideal Candidate
• Bachelor's degree in Life Sciences preferred
• 1+ year of experience in a GMP, Pharmaceutical, or Medical Device environment
• Recent graduates with strong documentation experience are also encouraged to apply
• Strong attention to detail, fast learner, and comfortable asking questions
• Familiarity with technical documentation for product design is a plus
• Experience reviewing documents in a GMP setting or working in quality-related roles
Key Responsibilities
• Ensure documentation submitted to Quality complies with regulatory requirements and internal policies.
• Review and audit Device History Files (DHF) and technical documentation including:
o Stability protocols/reports
o Validation/verification protocols and summaries
o Risk Management documents (FMEAs, plans/reports)
o Post-Market Surveillance and Performance Evaluation reports
o Product specifications, scientific, analytical, and clinical summaries
o Safety and Performance Requirement reports
• Assess and validate good documentation and record-keeping practices.
• Upload completed documents into electronic Document Management System (eDMS).
• Review and electronically approve quality records and reports.
• Participate in internal and external audits.
• Write, revise, or review procedures and work instructions as required.
• Collaborate with cross-functional teams to resolve quality issues and escalate concerns.
• Meet productivity standards while ensuring safety and compliance.
• Support management review meetings and assist with Rocklin site metrics documentation.
• Maintain training compliance and support weekend or extended work hours if needed.
• Demonstrate and communicate commitment to company mission, vision, and values.
️ Job Scope & Impact
• Impact: Limited impact on others; primarily responsible for the accuracy and efficiency of individual tasks.
• Complexity: Follows defined processes and procedures for documentation review and audit.
• Accountability: Works under close supervision with limited autonomy.
• Tools Used: eDMS, validated electronic systems, Microsoft Office Suite
• Reporting Structure: Typically reports to a Manager or Project Manager and works under daily guidance of a lead.
Requirements
Education:
• Preferred: Bachelor's degree in Life Science (e.g., Biology, Chemistry, Biomedical Sciences)
• Minimum: High school diploma or equivalent
Experience:
• At least 1 year of industry experience in quality, documentation, or GMP-regulated environment
• Experience with technical writing, documentation review, or product development files preferred
Additional Details
• Work Environment: 100% on-site at Rocklin location
• Site Closure Notice: The site is scheduled to close in February 2026
• Training: All employees must maintain current and up-to-date training records
• Flexibility: Must be willing to work weekends or extended hours as needed
Why Join Us?
• Opportunity to gain regulatory and quality experience in a well-established GMP setting
• Hands-on involvement in real-time audits and compliance activities
• Develop critical skills in technical documentation, DHF auditing, and quality systems
• Work alongside a supportive and knowledgeable quality assurance team
• Play a key role in ensuring regulatory compliance before the site transitions in 2026
Dayanara C Gracia
Technical Recruiter-Life Science
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