TEMP - Specialist, QA Product Complaints (Working in San Diego Office / Hybrid Work Schedule)

Role Summary

TEMP - Specialist, QA Product Complaints (Working in San Diego Office / Hybrid Work Schedule)

Responsibilities

• Records, resolves, and tracks product complaints in Neurocrine‚Äôs product complaint management system
• Triages incoming complaints and escalates critical complaints to Management
• Monitors complaint records, manages communication and follow-up of complaints to ensure timely complaint closure
• Performs product complaint investigation, root cause analysis and implementation of corrective or preventive actions for moderately complex complaints
• Interfaces with cross functional groups or CMOs to investigate reported complaints
• As part of complaint investigations, reviews relevant records, (e.g. batch records, quality control data, deviations/CAPAs)
• Performs reconciliation activities with Medical Information, Drug Safety, and other vendors as required
• Performs trending of product complaints and supports internal monthly and quarterly metrics for complaints
• Assists during compliance inspections and audit readiness as required
• Maintains tracking logs for product complaints and other quality systems as assigned
• Writes SOPs for the creation, development or improvement of processes related to quality systems
• Supports enhancements and upgrades to the Complaint System as required
• Participate in or conduct audits of external vendors
• Support more complex continuous improvement projects / initiatives under broad supervision

Qualifications

• BS/BA degree in Chemistry, Biology, or related field and 2+ years of experience with QC review, quality systems, and conducting external audits within the pharmaceutical or biotechnology industry. Preferred experience: analytical analyses for the small molecule pharmaceutical, biologics, peptides, or gene therapy industry, OR
• Master‚Äôs degree in Chemistry, Biology, or related field and some similar experience as noted above
• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs), quality assurance systems, methods and procedures
• Ability to apply root cause analysis tools for performing and reviewing investigations, writes reports with clarity and produces data reports with accuracy
• Knowledge of quality systems and internal and external audit processes
• High degree of focus and consistent attention to detail is required
• Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the small molecule pharmaceutical, biologics, peptides, or gene therapy industry is strongly desired
• Previous experience with electronic document management systems and in conducting internal audits is desired
• Demonstrates working knowledge of quality systems and regulatory compliance requirements within a development and/or commercial drug manufacturing operation is necessary
• Must possess an awareness of the relationship between sponsor companies and contract manufacturers
• Attention to detail, critical thinker, and effective organizational skills required
• Demonstrates initiative and drives action and results
• Strong communication and proficient soft skills
• Ability to solve problems and work collaboratively in a team environment

Skills

• Quality systems management
• Root cause analysis
• Investigation and documentation
• Cross-functional collaboration
• Regulatory compliance knowledge
• Audit readiness

Education

• BS/BA in Chemistry, Biology, or related field; or
• Master‚Äôs degree in Chemistry, Biology, or related field

Additional Requirements

• Awareness of sponsor company and contract manufacturer relationships