
Website Amgen
Job Summary
Amgen currently has a vacancy for those looking to work as a Amgen Job Openings – Specialist Quality Complaints for Full Time at their offices in Thousand Oaks, CA, US. Applicants should be sure to read the job outline attentively if they intend to apply.
Job Title: | Amgen Job Openings – Specialist Quality Complaints | Company Name: | Amgen | Job Location: | Thousand Oaks, CA, US | Job Type: | Full Time | Job Category: | Amgen | Job Link Expiry: | 2023-12-30 | Posted on: | Jobinton.com |
Job Details:
Job Description:
The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.
Job Responsibilities:
- Anticipates and prevents potential issues with regulators
- Quickly intensifies issues that could impede the ability to close records according to action plans
- Maintains compliance with local and global processes
- Ensures quality of complaint records
- Raises potential Quality issues to Management
- Evaluates subject matter professional assessments
- Execution of regulatory and SOP requirements
- Executes against prioritized work plans
- Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
- Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
- Provides guidance and technical advice
Job Requirements:
- Ability to oversee multiple projects simultaneously
- Ability to travel +/- 10% of time to domestic and international Amgen sites
- Bachelor’s Degree in a Science Field
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
- Ability to negotiate a position after taking feedback from multiple sources
- Ability to successfully manage workload to timelines
- 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
- Demonstrated ability to consistently deliver on-time, and high-quality results
- Familiarity with basic project management tools
- Ability to operate in a matrixed or team environment
Qualification & Experience:
- Doctorate degree
- Master’s degree & 3 years of Quality / Manufacturing experience
- Bachelor’s degree & 5 years of Quality / Manufacturing experience
- Associate’s degree & 10 years of Quality / Manufacturing experience
Job Details:
Company: Amgen
Vacancy Type: Full Time
Job Location: Thousand Oaks, CA, US
Application Deadline: N/A
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