Complaints Investigation Technical Investigator Biopharma JP10244
Complaints Investigation Technical Investigator Biopharma JP10244
Posted on :
05-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
05-04-2025
Job Description
Job Title: Complaints Investigation Technical Investigator Biopharma JP10244
Location: Thousand Oaks CA.
Employment Type: Contract
Business Unit: Complaints Trending
Duration: 1 years (with likely extensions)
Posting Date: 05/10/22
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 clients 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:
Preferred Qualifications:
Why is the Position Open
Supplement additional workload on team.
Top MustHave Skill Sets:
Day to Day Responsibilities:
Employee Value Proposition:
Exposure to different departments.
Red Flags:
Interview process:
Phone screening followed by inperson interview.
Location: Thousand Oaks CA.
Employment Type: Contract
Business Unit: Complaints Trending
Duration: 1 years (with likely extensions)
Posting Date: 05/10/22
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 clients 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:
- Masters degree and 3 years of related medical/biopharma development or Operations experience; OR
- Bachelors degree and 5 years of related medical/biopharma development or Operations experience; OR
- Associates degree and 8 years of related medical/biopharma development or Operations experience;
Preferred Qualifications:
- Bachelors Masters or PhD in Engineering Science or Biomedical
- 2 years of experience in complaints investigation within a development manufacturing postmarket 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 and writing standard operating procedures (SOP)
- Strong technical writing and interpersonal skills
- Resultsdriven and detailoriented team leader
Why is the Position Open
Supplement additional workload on team.
Top MustHave 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 FMEAs 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 clients packaged and/or distributed mechanical and/or electromechanical products
- Understand manufacturing processes for clients 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.
Red Flags:
- Job hoping
- No technical experience
- No experience with investigation/ technical investigation
Interview process:
Phone screening followed by inperson interview.
Regards
3KC Talent Acquisition Team
Employment Type
Full Time
Key Skills
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