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 Specialist Quality Complaints, Medical Device – Remote (JP9511)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Specialist Quality Complaints, Medical Device – Remote (JP9511)
Location: Thousand Oaks, CA (Remote)
Employment Type:  Contract
Business Unit: AutoTouch
Duration: 1+ years with likely extensions and/or conversion to permanent
Posting Date: 12/1/2021

3 Key Consulting is hiring a Specialist Quality Complaints for a consulting engagement with our direct client, a leading global biopharmaceutical company.


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

Job Description:
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

Authority
• 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 sites


Top Must Have Skills:
  • Ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timelines
  • Familiarity with basic project management tools

Day to Day Responsibilities:
Complaint record management

Employee Value Proposition:
Great supportive team
Opportunity to learn about qualit


Red Flags:
Lack of experience in industry
No quality experience; a minimum of 1-2 years
Degree: Science background


Interview process:
Phone and Phone Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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