What are the responsibilities and job description for the Quality Assurance Expert MEWPJP00028449 position at BEPC Inc. - Business Excellence Professional Consulting?
Quality Assurance Expert MEWPJP00028449
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
Mobile/Text: 325-735-5606
3242 Executive Dr. | San Angelo, Texas 76905
Email: dayanara.gracia@bepcinc.com
www.bepcinc.com
https://www.linkedin.com/in/daya-gracia/
Salary : $26 - $27
