Job Title: Clinical Product Complaint Analyst

Job Description

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

Responsibilities

• Assure complaint records meet global requirements.
• Document, investigate, and review all non-medical complaint content. Review medical complaints that involve non-medical quality related problems.
• Provide quality customer service through coordination of return samples for investigation and follow-up activities such as replacement of products.
• Ensure that complaint documentation meets Good Documentation Practices as well as GMP and GCP. Utilize good analytical skills, technical writing, and good documentation practices.
• Ensure complaint files meet all regulatory requirements.
• Identify potentially reportable events and notify appropriate functional groups and management.
• Interface with third-party manufacturers, healthcare professionals, the general public, internal customers, various functional areas, and regulatory agencies.

Additional Skills & Qualifications

• BS Degree with 1 year of FDA GxP GMP GLP GCP Quality experience
• Knowledge of global regulatory requirements for pharmaceutical, medical devices, and combination products
• Understanding of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820, and 211) is preferred
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred
• Solid written/verbal communication and organizational skills
• Knowledge and application of computer systems for word processing and complaint management
• Ability to work with cross-functional teams and interact effectively with peers, management, and customers

Work Environment

This is a hybrid role requiring three days on-site and two days working from home. Training will be conducted on-site for 2-3 weeks before the hybrid schedule starts. The standard work schedule is from 8:30 AM to 5:00 PM.

Pay and Benefits

The pay range for this position is $20.00 - $22.00/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 Austin,TX.

Application Deadline

This position is anticipated to close on Apr 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 : $20 - $22