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 email@example.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.