Description

Monitor and manage the Complaint Handling process to ensure timely and accurate processing of complaints to fulfill the customer and regulatory requirements.

Coordinate with customer service to get accurate and complete information about the complaint

Analyze product complaint and make critical judgment on potential reportability. Report events to appropriate Regulatory Agencies, if required

Work with operations and engineering to determine root cause and corrective/preventative actions

Conduct document review (batch records, deviations, out of specification reports, etc)

Prepare customer communications for complaints

Review and close complaint files

Generate complaint trending reports for analysis

Lead monthly complaint meetings to analyze complaint data

Assists in development and implementation of design of experiments and serves on problem solving teams

Review production batch/packaging records for Quality Assurance release

Draft, review, revise, and approve SOPs as relating to Complaint Handling and Quality assurance

Participate in continuous approval of site quality systems

Role is 50% floor and 50% desk-based duties.

Skills

Quality assurance, gmp audit, batch record review, complaint handling, quality inspection, fda

Additional Skills & Qualifications

Bachelor's Degree in a technical field (science, engineering, mathematics) Preferred but could substitute years of experience for degree

3-5 years Quality Assurance experience in an FDA regulated field (Med Device or Pharma preferred).

Batch Record or Document Review experience required.

Ability to perform data analysis and trending

Knowledge of regulatory standards, including but not limited to 21 CFR 820; 21 CFR 210/211; ISO 13485, ISO 14971, CMDR, MDD and JPAL is preferred.

Solid grasp of computer systems used in a manufacturing setting (Inventory System, MS Office, Quality System, etc.)

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $26.44 - $28.85

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 Earth City,MO.

Application Deadline

This position will be accepting applications until Jan 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.

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.