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

Role Summary

QA Specialist will perform a wide variety of activities supporting the product complaint system to ensure compliance with applicable internal procedures, good manufacturing practices, and pharmaceutical regulatory requirements. This position will be responsible for recording, resolving, and tracking product complaints. This key functional role will operate within a cross-functional GXP QA Team and supports internal QA functions. Under general supervision, this individual may assist with more complex audits to ensure compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements.

Responsibilities

• Records, resolves, and tracks product complaints in Neurocrine’s 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’s 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
• Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the small molecule pharmaceutical, biologics, peptides, or gene therapy industry strongly desired
• Previous experience with electronic document management systems and in conducting internal audits desired
• Demonstrates working knowledge of quality systems and regulatory compliance requirements within a development and/or commercial drug manufacturing operation
• Must possess an awareness of the relationship between sponsor companies and contract manufacturers
• Attention to detail, critical thinker, and effective organizational skills
• Demonstrates initiative and drives action and results
• Strong communication and proficient soft skills
• Ability to solve problems and work collaboratively in a team environment

Education

• BS/BA degree in Chemistry, Biology, or related field
• Master’s degree in Chemistry, Biology, or related field

Skills

• Strong communication and proficient soft skills
• Critical thinking and problem-solving
• Detail-oriented with strong organizational abilities
• Ability to work collaboratively in a cross-functional team