Specialist Quality Complaints
The Judge Group Inc.
Job Info
Location: REMOTE
Salary: $40.00 USD Hourly - $46.00 USD Hourly
Description:
Ideal candidate: Master degree OR Bachelor degree in life sciences Biopharmaceutical background 3-5 years in. A strong foundation in product security assessments, particularly focused on investigating product complaints with a potential security event, such as counterfeit or tampered products. Key technical skills include familiarity with specific systems like BioConnect, a Salesforce-based GMP complaints system, along with PCMT, SAP, and potentially BTRS. Knowledge of Smartsheet would be advantageous, especially for audit-related tasks. Proficiency with the Microsoft Office suite, especially Excel, Word, and PowerPoint, is also necessary.
Description:
Primary responsibilities include: Supporting the product complaint system at Amgen through the auditing of product complaint records and monitoring of complaint data in adherence with Amgen 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.
FUNCTIONS
1. 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.
2. Candidate will be responsible for working cross functionally with other Amgen departments, contract partners, and call centers to resolve discrepancies/deficiencies.
3. 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.
4. Complete assessments to support complaint activities as needed.
OTHER QUALIFICATIONS
• 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.
Basic Qualifications
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
Attention to detail
Quality oversight experience
Well-organized with excellent oral and written communication skills
Day to Day Responsibilities:
Perform audits of a selection complaint records to ensure completion, accuracy, and quality documentation
Perform Product Security Assessments to evaluate the authenticity of a complaint and any security issues surrounding it
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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