QA Complaint Specialists

$83,200 - $104,000/Yr

Actalent - Roxbury Township, NJ

Full-time - Entry Level

Roxbury Township, NJ

10,001+ employees

Administrative and Support Services

About the position

The QA Complaint Specialist is responsible for ensuring that manufacturing procedures comply with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and FDA standards. This role involves managing product complaints, conducting investigations, and collaborating with various departments to maintain quality assurance and meet regulatory requirements.

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 complaints investigation.
• 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 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.

Requirements

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

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)