QA Complaints Specialist

Harrowhealth; Ledgewood (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Harrowhealth is seeking a Quality Assurance Complaints Specialist located in Ledgewood, New Jersey. This role involves ensuring compliance with manufacturing procedures, particularly in handling product complaints and maintaining quality standards as per SOPs and regulatory mandates.

The ideal candidate will have a Bachelor’s degree in life sciences and a minimum of 2 years' experience in a pharmacy operation or cGMP environment. Strong communication and critical thinking skills are essential.

Qualifications

• 2+ years of experience in pharmacy operation or in a cGMP environment.
• Ability to produce thorough and compliant complaint investigations.
• Strong organizational skills with the ability to maintain attention to detail.

Responsibilities

• Handle product complaints from the customer service department.
• Evaluate complaints for regulatory reportability.
• Initiate appropriate Corrective Action/Preventative Action plans.

Skills

Collaboration

Communication skills

Database management

Critical thinking

Education

Bachelor’s degree in life sciences

Tools

Word

PowerPoint

Excel

Job description

Job Summary

The Quality Assurance Complaints Specialist ensures manufacturing procedures are followed in accordance with SOPs, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The position supports operational needs and activities 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 Standard Operating Procedures (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.
• Ensures 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.
• Ability 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).
• 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