QA Complaints Specialist

Job Summary

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The position supports operational needs and activities in order to successfully achieve quality goals and complaints metrics.

Core Responsibilities

• Handles product complaints received from customer service department.
• Initiates, process and send notifications as required by applicable Standard Operating Procedures (SOPs).
• Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.
• Evaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.
• Writes, investigates and ensures timely submission of complaints investigation.
• Reviews and approves complaint investigation submitted by other team members.
• Collaborates with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly.
• Initiates applicable Corrective Action/Preventative Action (CAPA) plans.
• Accurately maintain product complaint logs (softcopy and hardcopy) through internal database tracking system and complete all filing and closing procedures as required by applicable Standard Operating Procedures (SOPs)
• Responsible for ensuring that paperwork is complete for each complaint folders.
• Perform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

• Bachelor's degree required, preferably life sciences
• 2+ years of experience in pharmacy operation or experience in cGMP environment
• Must be able to facilitate collaboration, while knowing when to move to end analysis and recommend decisions
• Strong written, verbal and presentation communication skills
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) required
• Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards

Position Type

• On-Site

Travel

• None