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Specialist Quality Complaints

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:                                                            
  • Ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
Day Day Responsibilities:                                    
  • Lab based role
  • Performing analytical testing in the lab to support a variety of studies following methods and procedures.
  • Making mobile phases using standard lab equipment (pH meters, balances, pipettes).
  • Troubleshooting equipment issues if needed.
  • Communicating to the group and discussing data at meetings.

Ideal candidate- BS in science, PM skills, Complaints experience within medical devices, detailed orientated. Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment

Accountable to conduct complex complaint investigations, determine corrective actions with their effectiveness and determine the steps necessary to ensure the proper level of control for product in distribution.

Key Responsibilities
Ensures quality of complaint records
Applies analytical skills to evaluate complex situations using multiple sources of information
Execution of regulatory and SOP requirements
Anticipates and prevents potential issues with regulators
Provides guidance and technical advice
Evaluates subject matter expert assessments
Escalates potential Quality issues to Management

Owns complex quality record content
Determines situations which require escalation to management
Determines when a complaint dictates further investigation
Works under minimal direction
Proposes revisions to SOPs in area of responsibility

Basic Qualifications:
Doctorate degree OR
Master’s degree & 2 years of directly related experience OR
Bachelor’s degree & 4 years of directly related experience OR
Associate’s degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:
  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • Ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel +/- 10% of time to domestic and international To this company sites

"This posting is for Contingent Worker, not an FTE"

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