Complaints Associate Specialist Quality Operations

Pfizer • Kalamazoo, MI

2d • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or another science-related discipline preferred, with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (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 one's own team and interdepartmental teams
• Effective written and oral communication skills
• Proficiency in Microsoft Office applications, particularly Excel

Nice To Haves

• 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 such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

Responsibilities

• 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.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level