QA Complaints Specialist

Harrow, Inc.; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

Harrow, Inc. is seeking a Quality Assurance Complaints Specialist to ensure compliance with manufacturing procedures, SOPs, cGMP, and FDA standards in the United States. The role involves handling product complaints, collaborating with customer service, and conducting thorough investigations. The successful candidate will hold a Bachelor's degree in life sciences and have 2+ years of experience in a cGMP environment, with strong skills in communication and database management. This is an on-site position with no travel required.

Qualifications

• 2+ years of experience in pharmacy operation or in a cGMP environment.
• Strong ability to facilitate collaboration and recommend decisions.
• Ability to work under pressure and meet deadlines.

Responsibilities

• Handles product complaints received from customer service department.
• Writes, investigates, and ensures timely submission of complaint investigations.
• Collaborates with departments to address technical issues thoroughly.

Skills

Collaboration

Communication skills

Critical thinking

Database management

Computer skills (Word, PowerPoint, Excel)

Education

Bachelor’s degree in life sciences

Job description

Job Summary

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), 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, processes and sends notifications as required by applicable SOPs.
• Interacts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.
• Evaluates complaints for regulatory reportability and creates and submits reports that comply with applicable regulations.
• Writes, investigates and ensures timely submission of complaint investigations.
• Reviews and approves complaint investigations 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 maintains product complaint logs (softcopy and hardcopy) through internal database tracking system and completes all filing and closing procedures as required by applicable SOPs.
• Responsible for ensuring that paperwork is complete for each complaint folder.
• Performs other duties and assumes responsibilities as appropriate or assigned.

Qualifications & Requirements

• Bachelor’s degree required, preferably in life sciences.
• 2+ years of experience in pharmacy operation or in a 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

As set forth in Harrow, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of the basis of any protected group status under any applicable law.