Job Title: Complaints Investigation Technical Investigator - (JP10099) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: Commercial Drug Product Data Science Duration: 1+ years (with likely extensions) Notes: Must be fully vaccinated. Onsite. M-F.
Posting Date: 04/15/2022
3 Key Consulting is hiring a Complaints Investigation Technical Investigator for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: Our client is currently seeking a complaints investigation technical investigator in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of client’s mission to serve patients, the Complaints Trending and Investigation group at Amgen is a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.
The complaints investigation technical investigator will conduct technical investigations of Level 2 and 3 complaints associated with product design and/or usability issues, as well as conduct trend and consolidated investigations using data analytics. S/he will be responsible for the validity and integrity of the investigations and reports, including the data and its statistical analysis. S/he will also participate and/or lead in cross functional ideation of design solutions. The complaints investigation technical investigator maintains close interaction with the engineering and quality management functions to contribute to product improvement and management reporting. Additionally, s/he will support the implementation and validation of the equipment in the investigation lab.
Master’s degree and 3 years of related medical/biopharma development or Operations experience; OR
Bachelor’s degree and 5 years of related medical/biopharma development or Operations experience; OR
Associate’s degree and 8 years of related medical/biopharma development or Operations experience;
Bachelor’s, Master’s or PhD in Engineering, Science or Biomedical
2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
Experience with statistics and statistical analysis
Demonstrated competency in root cause analysis methodology
Experience with protocol and report writing, process and test development and execution, and writing standard operating procedures (SOP)
Strong technical writing and interpersonal skills
Results-driven and detail-oriented team leader
Why is the Position Open? Supplement additional workload on team.
Top Must-Have Skill Sets:
Good oral and written communications skills
Day to Day Responsibilities:
Lead root cause analysis of mechanical and/or electromechanical products to identify root cause using tools such as tolerance analysis, fishbone diagrams, “5 Whys”, and risk assessments such as FMEA’s or Fault Tree Analysis
Perform trend and consolidated investigations. Accountable for validity of statistical assessment of data to identify trends, as well as ownership of monthly reports
Perform technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
Develop and perform relational data analytics in support of investigations
Deliver reports and investigations on time per client and regulatory requirements
Understand customer / patient use of client’s packaged and/or distributed mechanical and/or electromechanical products
Understand manufacturing processes for client’s packaged and/or distributed products
Support the implementation and management of the lab infrastructure, including all equipment used for investigations
Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
Employee Value Proposition: Exposure to different departments within client organization.
Red Flags: Job hopping.
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.