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Abbott · 6 days ago

QA Specialist II

Alameda, CA

Contract

Onsite

Mid Level

3+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The QA Specialist II role focuses on assuring the quality of manufactured products and processes, maintaining the quality system, and ensuring compliance with GMP and quality management systems.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

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

Qualification

Quality Management SystemsGMP Documentation ReviewCAPA Process ParticipationSOP WritingRevisionQuality Metrics AnalysisComplaint HandlingISO13485 FamiliarityPost Market SurveillanceElectronic Support SystemsCollaboration Skills

Required

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