Job Description:

This position will responsible for conducting thorough investigations into manufacturing deviations, non-conformances, and other quality issues, ensuring all investigations are conducted in accordance with current Good Manufacturing Practices (cGMP) regulations, aiming to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards.

This position will collaborate with internal Subject Matter Experts (e.g. Analytical, Manufacturing, Packaging and Quality and IT personnel). Additionally, this role will work with customers to ensure timely reporting of Quality incidents and customer concurrence with audit findings and Corrective and Preventive Actions (CAPAs). This role requires strong computer skills as well as problem solving skills. 

Duties:

• Lead investigations into Quality Events and customer complaints

• Perform root cause analysis using industry standards, such as 5Whys and Fishbone diagrams 

• Determine relevant corrective and preventative action 

• Perform risk assessment to determine safety and efficacy of product 

• Oversee timely completion of deviations, CAPAs, investigations, complaints

• Track and trend events/deviations 

• Provide communication plans for ongoing deviations and CAPAs

• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices

• Proactively raise quality related risks, issues, and opportunities.

Qualifications:

• 3-5 years of experience in cGMP/GMP environment.

• 3-5 years of conducting deviation/nonconformance investigation experience, QA, and implementing Corrective and Preventative Actions (CAPA).

• Experience in technical writing and documentation, with proficiency in Trackwise and Microsoft applications.

Pay and Benefits

The pay range for this position is $65000.00 - $70000.00

• 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 Lakewood,NJ.

Application Deadline

This position will be accepting applications until Jan 23, 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.

Salary : $65,000 - $70,000