We are seeking a detail-oriented and experiencedQA Complaints Specialistto join our Quality Assurance team. This role is responsible for leading investigations into customer complaints, identifying root causes using various methodologies, and implementing effective corrective and preventive actions (CAPAs). The ideal candidate will have a strong understanding of FDA GMP regulations, pharmaceutical manufacturing processes, and a commitment to high-quality standards.
Key Responsibilities:Conduct and lead investigations into product complaints using root cause analysis tools.Write clear, concise, and timely complaint investigation reports.Evaluate complaints for regulatory reportability and submit reports in compliance with applicable regulations.Collaborate with cross-functional teams to ensure thorough and accurate investigations.Initiate and manage CAPA plans based on investigation findings.Interact with customer service and customers to gather necessary information for complaint resolution.Maintain accurate complaint logs and ensure all documentation complies with SOPs.Review and approve complaint investigations conducted by other team members.Ensure completeness of complaint documentation and proper filing of complaint folders.Initiate and process notifications as required by SOPs.Perform additional duties as assigned.Qualifications:Bachelor’s degree in a scientific or technical discipline (preferred).Minimum [X] years of experience in pharmaceutical QA or a related field.In-depth knowledge of FDA GMP regulations and pharmaceutical manufacturing processes.Strong analytical and problem-solving skills.Excellent written and verbal communication skills.Ability to simplify complex technical issues for diverse audiences.Proficiency in using complaint tracking systems and Microsoft Office Suite.
Pay and Benefits
The pay range for this position is $40.00 - $50.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• 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)
Workplace Type
This is a fully onsite position in Ledgewood,NJ.
Application Deadline
This position is anticipated to close on Jun 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.