Job Title: QA Complaint Specialist

Job Type: 2 Month Renewable Contract - This position is a \"Go to Work\" and can start immediately! (Fully Onsite)

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

•\tHandles product complaints received from customer service department.

•\tInitiates, process and send notifications as required by applicable Standard Operating Procedures (SOPs).

•\tInteracts with customer service and customers to acquire additional information that may be required to effectively investigate a product complaint.

•\tEvaluate complaints for regulatory reportability and create and submit reports that comply with applicable regulations.

•\tWrites, investigates and ensures timely submission of complaints investigation.

•\tReviews and approves complaint investigation submitted by other team members.

•\tCollaborates with other departments to ensure technical issues are being addressed and investigations are conducted thoroughly.

•\tInitiates applicable Corrective Action/Preventative Action (CAPA) plans.

•\tAccurately 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)

•\tResponsible for ensuring that paperwork is complete for each complaint folders.

•\tPerform other duties and assume responsibilities as appropriate or assigned.

Qualifications & Requirements

•\tBachelor’s degree required, preferably life sciences

•\t2+ years of experience in pharmacy operation or experience in cGMP environment

•\tMust be able to facilitate collaboration, while knowing when to move to end analysis and recommend decisions

•\tStrong written, verbal and presentation communication skills

•\tStrong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) required

•\tAbility to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and   high ethical standards

Pay and Benefits

The pay range for this position is $40.00 - $50.00

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 will be accepting applications until Jan 1, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.