Overview
Quality Assurance Advisor Jobs in Pomona, CA at Southern California Edison
Key Responsibilities:
· Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.
· Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.
· Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.
· Review all documentation for adherence to organizational quality standards.
· Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.
· Provide QA support of change controls, deviations, investigations, CAPA’s and effectiveness checks.
· Develop and maintain compliance-related trending metrics and reports.
· Makes appropriate recommendations for correction and improvement as may be necessary.
· Provide oversight of personnel training record management.
· Provide QA support of internal and external audits, as assigned.
· Reviews and updates Quality Assurance procedures.
· Maintains audit forms and QA records.
· Other duties as needed.
Qualifications:
· Bachelor’s degree in quality assurance or science-related field.
· Minimum of 5 years in GxP or equivalent regulatory environment.
· Excellent knowledge of GLP and GCP requirements.
· Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
· Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.
· Able to understand published methodology to audit existing test methods and ensure accuracy.
· Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.
· Experience performing quality process audits and review of deviations and CAPA.
· Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).
· Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.
· Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.
· Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.
· Background in molecular biology, virology and/or serology is a plus.
· Contract research organization (CRO) experience is a plus.
· Experience with eQMS (Qualio) is a plus.
Job Type: Full-time
Pay: $75,000.00 – $90,000.00 per year
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Schedule:
Monday to Friday
Education:
Bachelor’s (Preferred)
Experience:
QA: 5 years (Required)
GxP: 3 years (Preferred)
CAPA investigation: 1 year (Required)
GLP lab setting (21 CFR Part 58): 3 years (Required)
ISO 9001 or other quality management systems: 1 year (Preferred)
Ability to Relocate:
Rochester, MN 55901: Relocate before starting work (Required)
Work Location: In person
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Title: Quality Assurance Advisor
Company: Southern California Edison
Location: Pomona, CA
