Title: QA Specialist II
Location: Alameda, CA
Duration: 12 Months
100% Onsite
Shift Time: 8am to 5pm
Job Summary
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.
Top 5 Skills
- 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.
Job Responsibilities
- 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.
Education
- 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
Preferred Experience
- Direct experience in a Quality or Regulatory Affairs role in a GMP-related industry
- Complaint handling experience and familiarity with ISO13485
- Familiarity with electronic support systems such as TraqWise, GQMS, Salesforce, Excel, Powerpoint
- Strong collaboration skills with internal groups to respond to product inquiries and issues
- Participation in process or project-driven teams.
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.
