Job Title: Product Complaint Analyst

Job Description

You will work in a global quality organization processing pharmaceutical, medical device, and combination product complaints and inquiries. You will interface with internal customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization, and PV regarding product complaints. You will be responsible for product complaint documentation, investigations, and identification of potential adverse events and potentially reportable events. Responsibilities may include creation and submission of regulatory reports, creation of customer communications, and interface with various third parties.

Responsibilities

• Assure complaint records meet global requirements.
• Document, investigate, and review all non-medical complaint content and medical complaints that involve a non-medical quality-related problem.
• Provide quality customer service through coordination of return samples for investigation and follow-up activities such as replacement of product.
• Ensure that complaint documentation meets Good Documentation Practices, GMP, and GCP. This requires good analytical skills, technical writing, and good documentation.
• Ensure complaint files meet all regulatory requirements.
• Identify potentially reportable events and notify appropriate functional groups and management.
• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, functional areas, and regulatory agencies.

Essential Skills

• Quality assurance
• FDA regulations
• Proficiency in Microsoft Excel, including pivot tables, sorting, and filtering
• Understanding of GCP, GMP, GLP
• Experience in Pharmaceutical and Medical Device industries
• Handling of complaints, adverse events, and product surveillance
• Familiarity with laboratory, R&D, and clinical trials
• Regulatory knowledge

Additional Skills & Qualifications

• BS Degree in Science or Healthcare
• 6 months to 3 years of work experience in a cGMP related industry or clinical setting is preferred

Work Environment

The position is hybrid, located in Lake County.

Pay and Benefits

The pay range for this position is $23.00 - $23.00/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 hybrid position in Waukegan,IL.

Application Deadline

This position is anticipated to close on Feb 19, 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 : $23