Complaints Handler Jobs

Due to tremendous growth, Indeio is looking for a Complaint Handler with knowledge of medical device manufacturing and GMP to support an innovative client with the continued new product development.

About us:

We are a spirited, high-growth company focused on the success of our clients and our colleagues. We put a new spin on consulting that allows our team to work at or with some of the world’s largest and well-known medical device and pharmaceutical companies.

Qualifications

• Minimum two (2) years of experience in a GMP relevant environment

• Experience conducting complaint investigations and root cause analysis

• Proficient knowledge of general office procedures

• Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook)

• Proficient knowledge of Good Documentation Practices (GDP) relating to complaint handling

• Proficient knowledge of medical terms and human anatomy

• Advanced knowledge and interpretation of domestic and international complaint handling and reporting requirements required

• Demonstrated knowledge of statistical data analysis tools and techniques

• Demonstrated knowledge of good laboratory practices, including handling of chemicals and biohazardous material

• Demonstrated problem-solving, critical thinking, and investigate skills

• Demonstrated prioritization and time management skills

• Ability to prioritize and organize project tasks and goals effectively

• Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness

• Ability to read technical diagrams, graphs, and instructions

Responsibilities

• Performs routine testing on products returned from the field due to customer complaint; utilizes a variety of lab equipment to perform testing

• Coordinates, evaluates, investigates, tracks, and performs complaint testing and investigations through established complaint handling processes and procedures

• Reviews relevant records (e.g. batch records, quality control data, deviations/CAPAs) and performs authenticity assessment of all received complaint samples

• Serves as a subject matter expert (SME) for applicable procedures and work instructions related to investigation process; collaborates with subject matter experts (SMEs) in other departments to adequately evaluate and investigate complaints

• Summarizes and records all test data when applicable; maintains proper documentation of the evaluation and investigation results within the assigned complaint file(s)

• Performs and/or verifies results of visual and/or functional analysis of returned complaint samples per local procedures

• Applies cGMP and cGLP principles in all phases of the product complaint investigation (e.g., data documentation)