Complaints Investigation Technical Investigator, Biopharma

Complaints Investigation Technical Investigator

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

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 client 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.

Basic Qualifications:

• 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;

Preferred Qualifications:

• 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

Supplement additional workload on team.

Top Must-Have Skill Sets:

• Good oral and written communications skills
• Detail oriented
• Technical degree
• Experience with root cause analysis and technical investigation

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

Exposure to different departments.

Red Flags:

• Job hoping
• No technical experience
• No experience with investigation/ technical investigation

Phone screening followed by in-person interview.