QA Specialist II

Title: QA Specialist II
Location: Alameda, California(100% Onsite)
Duration: 12

Months
Shift Time: 8am to 5pm
Pay Range: $40/hr to $44/hr (On W2)

We are looking for a “QA Specialist”to join one of our Fortune 500 clients.

Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). Subject matter expert, primary function of the Quality Specialist is to assist in maintaining the quality system.

• Experience in ensuring compliance with Quality Management Systems, including complaints coordination, batch release, exception reports, CAPA, document control, surveillance, testing, batch and sample retention, and metric maintenance.
• GMP Documentation Review:
  Ability to review GMP-related documentation for compliance, including batch records, product manufacturing, testing and release, validation protocols, labels, product specifications, etc.
• CAPA Process Participation:
  Experience in participating in the Corrective Action/Preventive Action (CAPA) process, including investigating failures or deviations in the manufacturing area.
• SOP Writing and Revision:
  Skills in writing and revising Standard Operating Procedures (SOPs), controlled forms, and related documents to ensure best practices and alignment with current operations.
• Quality Metrics Analysis:
  Ability to collect, analyze, and publish quality metrics, and provide data for support of budgetary submissions.

• CAPA management, including investigation, documentation, and timely closure of exception reports.
• Global complaint handling process execution, including intake, evaluation, closure, and reportability.
• Complaint procedure writing and redlining to align with global regulatory requirements.
• Batch release support through GMP documentation review and compliance verification.
• Document control, including SOP writing, revision, and lifecycle management.
• Quality metrics collection, analysis, and reporting to support internal reviews and audits.
• Post-market surveillance data coordination and reporting.
• Batch and sample retention oversight in compliance with regulatory and internal standards.
• Cross-functional collaboration with internal teams, including the Medical Events Group, to resolve product quality issues and support regulatory responses.

• BS degree or 3-7 years, working with complaint/ med device OUS/ Redline procedures/ Report ability/ experience/ CAPA evaluation and closure/ reportability/ report the complaint file.. oversee the procedures (Not Change control) (Not Manufacture QA)
• Associate Degree with complaint experience 3-7 years / Master degree may apply
• Documentation proactive / compliant experience/ working cross function
• Post Market Surveillance experience is as plus/ Analyst work

• Direct experience in a Quality or Regulatory Affairs role in a GMP-related industry
• Complaint handling experience and familiarity with ISO
  13485
• Familiarity with electronic support systems such as Traq Wise, GQMS, Salesforce, Excel, Powerpoint
• Strong collaboration skills with internal groups to respond to product inquiries and issues
• Participation in process or project-driven teams.

We are looking for the candidate who are eligible to work with any employers without sponsorship
.

If you’re interested, please click “Apply” button