QA Specialist II

Title: QA Specialist II

Location: Alameda, CA

Duration: 12 Months | 100% Onsite

Job Summary:

We are seeking a detail-oriented QA Specialist II to join our quality team. The ideal candidate will serve as a subject matter expert responsible for maintaining and supporting the Quality Management System (QMS) in a GMP-regulated environment. This role will primarily focus on complaint handling, CAPA management, document control, and post-market surveillance, while supporting cross-functional collaboration and compliance initiatives.

Key Responsibilities:

• Lead and manage CAPA investigations, documentation, and ensure timely closure of exception reports.
• Execute the global complaint handling process including intake, evaluation, documentation, reportability assessments, and closure.
• Draft and revise complaint-related procedures to ensure alignment with global regulatory requirements.
• Support batch release activities through GMP documentation review and compliance verification.
• Manage document control, including SOP authoring, revision, and lifecycle maintenance.
• Collect, analyze, and report quality metrics for audits and internal reviews.
• Coordinate and report post-market surveillance data.
• Oversee batch and sample retention processes in accordance with internal and regulatory standards.
• Collaborate cross-functionally with internal stakeholders, including the Medical Events Group, to address product quality issues and support regulatory submissions.

Top 5 Required Skills:

1. Compliance & Documentation: Strong experience ensuring QMS compliance, complaint coordination, CAPA execution, document control, batch/sample retention, and surveillance reporting.
2. GMP Documentation Review: Proficiency in reviewing GMP documents such as batch records, validation protocols, labels, product specs, and test records.
3. CAPA Management: Experience in the full CAPA lifecycle including root cause analysis, action implementation, and timely closure.
4. SOP Authoring: Skilled in writing, editing, and maintaining SOPs and controlled forms to reflect current operations and best practices.
5. Quality Metrics: Ability to collect, analyze, and present quality metrics in support of continuous improvement and compliance efforts.

Preferred Qualifications:

• Direct experience in a Quality or Regulatory Affairs role in a GMP-compliant, medical device, or pharmaceutical setting.
• Experience with complaint handling, ISO 13485 standards, and post-market surveillance.
• Familiarity with electronic quality systems such as TrackWise, GQMS, Salesforce, and Microsoft Office (Excel, PowerPoint).
• Strong interpersonal and collaboration skills for cross-functional engagement and issue resolution.
• Experience working within project-driven or process improvement teams.

Education & Experience Requirements:

• Required: Associate degree with 3–7 years of relevant experience.
• Preferred: Master’s degree with relevant complaint handling and quality assurance experience.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

 Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.