Complaints Associate Specialist Quality Operations

Use Your Power for Purpose

As a Complaints Associate Investigator within Kalamazoo Quality Operations you will play a critical role in ensuring customer complaints are managed effectively compliantly and on time. You will support product quality investigations by coordinating complaint intake activities managing complaint sample logistics performing product trend analyses and conducting complaint investigations for selected complaint categories.

This role provides an excellent opportunity for an early-career quality professional to develop investigation and compliance skills while contributing to continuous improvement initiatives. Success in this role requires strong organizational skills attention to detail a customer-focused mindset and a willingness to leverage digital and AI-enabled solutions to improve efficiency and effectiveness. You will work collaboratively within the Complaints Team and across multiple site and global functions to positively impact product quality customer experience and team performance.

What You Will Achieve

In this role you will:

• Track incoming complaints for products for the complaints team.
• Manage intake and triage activities for contract manufactured product complaints ensuring accurate documentation prioritization and timely assignment.
• Support Annual Product Review (APR) activities through complaint trending data analysis and preparation of periodic quality reports.
• Run trend reports to support a wide variety of investigations and requests for information including monthly QRM data for QO leadership.
• Independently author and complete low-complexity complaint investigations in accordance with applicable Global Standard Operating Procedures (GSOPs) and Global Work Instructions (GWIs).

• Drive investigation completion by established target dates through effective planning follow-up and coordination with stakeholders.
• Maintain and monitor complaint return sample activities including sample tracking import coordination receipt processing and reconciliation activities.
• Own designated laboratory support and workplace organization responsibilities including laboratory audits material management including controlled substance management and 5S activities that promote compliance efficiency and a safe working environment.
• Identify opportunities to improve processes through standardization automation digital tools and AI applications that enhance team effectiveness and operational efficiency.
• Demonstrates flexibility and willingness to support team priorities assume backup responsibilities and contribute positively to team culture and overall business results.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree in a Chemistry Biology Microbiology Engineering or another science-related discipline preferred with 0 years of experience; OR an associates degree with 4 years of experience; OR a high schooldiploma (or equivalent) and 6 years of relevant experience
• Experience in the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment both within ones own team and interdepartmental teams
• Effective written and oral communication skills
• Proficiency in Microsoft Office applications particularly Excel

Bonus Points If You Have (Preferred Requirements)

• Experience in a pharmaceutical medical device biotechnology laboratory manufacturing or regulated environment.
• Familiarity with quality systems investigations deviations complaints or corrective and preventive action processes.
• Experience in production batch record review Enterprise Resource Planning system and change control management
• Experience performing data analysis trending or reporting activities
• Excellent time management and multitasking abilities
• Experience using common AI tools including generative technologies suchas ChatGPT or Microsoft Copilot to support problem solving and enhance

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift up to 35 pounds

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Generally First shift 8:00-4:30. Extended work hours or weekend work may be required.

Work Location Assignment:On Premise

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.