Supporting the product complaint system at client through the auditing of product complaint records and monitoring of complaint data in adherence with client Complaint policies and procedures, while assuring compliance to federal regulations.
Data analysis to support complaint team activities as needed. Complete assessments to support complaint activities as needed.
Candidate will be responsible for; ensuring complaints are accurately documented in the complaints data base and that the appropriate investigation has been performed, as well as determining whether the complaint is associated with an adverse event or medical device.
Candidate will be responsible for working cross functionally with other client departments, contract partners, and call centers to resolve discrepancies/deficiencies.
Additional responsibilities include prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe, notifying appropriate parties upon audit completion of complaints, providing written communication to senior management and team members, and performing other duties as assigned by supervisor.
Complete assessments to support complaint activities as needed.
Why is the Position Open? Supplement additional workload on team.
Top Must Have Skills:
Complaints in FDA regulated industry experience.
GDP documentation experience and understanding.
Ability to evaluate issues, make decisions and determine when to escalate, as necessary.
Day to Day Responsibilities:
Auditing of product complaint management records.
Understanding the complaint handling process from initiation to closure.
Maintain current knowledge of the Regulatory regulations.
Complete product security assessments and investigations.
Other duties as assigned.
Basic Qualifications: Doctorate degree OR Master’s degree & 1 years of experience directly related to the job OR Bachelor’s degree & 2 years of experience directly related to the job
The candidate must be self-motivated, able to interface effectively with various levels, have careful attention to details and an understanding that accuracy and precision in all aspects of work are necessary. Candidate must be able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix-managed GMP environment.
Candidate must be well-organized, possess excellent oral and written communication skills, focus on process improvements, possess ability to manage a large number of complex projects simultaneously, and have the ability to function in a fast-paced environment. Candidate must possess the ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.
Employee Value Proposition:
Great biotech/pharma to work for.
Video Skype Panel Interview
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.