QA Specialist II

Title: QA Specialist II

Location: Alameda, CA

Duration: 12 month

Job description:

The primary function of the Quality Specialist is to assist in maintaining the quality system. This role involves responsibilities such as:

•  Batch release
•  Complaint coordination
•  Metric maintenance
•  Surveillance program
• Testing program
•   Document control
•  Exception report and CAPA system
•  Batch and sample retention and maintenance

Top 5 Skills/Requirements for the Resume

• Quality Management Systems Compliance: 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.

Preferred Requirements:

• 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.
• Years of Experience Required: 3-7 years

Required Education: Associate Degree (±) required

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.