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Manufacturing Specialist Investigations - Biotech (JP7860)

West Greenwich, RI · Biotech/Pharmaceutical
Job Title:  Manufacturing Specialist Investigations - Biotech (JP7860)
Location: West Greenwich, RI.  02817.  (Remote pending lifting of COVID restrictions – work in EST time zone)
Employment Type:  Contract
Business Unit: ARI Manufacturing
Duration: 3 months (with likely extensions)
Posting Date: 10/27/2020
3 Key Consulting is hiring an Manufacturing Specialist Investigations for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Our ideal candidate will have previous experience with client, demonstrated Six Sigma proficiency specifically for root cause analysis methodology, experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives.  Candidate will be working remote in EST & required to be on site once it re opens.
Company’s Rhode Island operations is currently seeking a Manufacturing Specialist Investigator (External worker) in their site Investigation group. In support of company’s mission to serve patients, they are a diverse team working to continuously improve their clinical and commercial drug Substance Operations to ensure supply and to optimize the patient experience. The Manufacturing Specialist Investigator - conducts technical investigations from their clinical and commercial drug Substance Operations. This role understands the investigation process as well as manufacturing processes for the Rhode Island Facility. The Manufacturing Specialist Investigator owns major and trend deviations to support identifying root cause and will also participate in multi-functional idealization of design solutions (CAPAs). Also maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and contribute to product/process improvement.
Why is the Position Open?
Top Must-Have Skill Sets:
  • Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
  • Demonstrate understanding and application of Drug Substance process, data mining, Microsoft office tool, Quality and compliance.
  • Strong technical writing and interpersonal skills (able to influence trifunctional team and organizational leads)
Day to Day Responsibilities:
  • Lead root cause analysis to identify the failure mode using root cause analysis.
  • Identify root cause using tools such as fishbone diagrams, “5 Whys”, KT, Process mapping, and risk assessments such as FMEA’s or Fault Tree Analysis.
  • Applies knowledge and subject matter expertise to ensure end-to-end of investigations.
  • Lead discussion to reduce correct, mitigate and prevent the re-occurrence of the event based on output of root cause analysis.
  • Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports (as needed).
  • Generate final technical reports in accordance with established procedures, which may include data collection and statistical analysis of the data.
  • Develop in conjunction with the technical team product impact assessment in support of investigations.
  • Perform notification of potential product impact in accordance with established procedures.
  • Advise management on investigation progress, product/ process risk, and potential delays in the investigation process.
  • Support functional management initiatives and objectives.
  • Anticipates and prevents potential issues with regulators.
  • Own and/or Drive Improvement projects/initiatives.
  • Collaborate cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Alert senior management of quality, compliance, supply and safety risks.
  • Attend and contribute to staff meetings and attend appropriate training sessions, as required.
  • Lead safe working practices and safety initiatives within their functional area.
Basic Qualifications:
  • Doctorate degree OR Master’s degree and 3 years of Bio pharmaceutical Operations experience OR Bachelor’s degree and 5 years of Bio pharmaceutical Operations experience.
  • 2+ years of experience in investigation process industry experience, non academia within biopharm environment.
  • Must have previous technical writing experience, experience In investigation process (RCA) and Drug Substance Experience.
  • Demonstrate understanding and application of Drug Substance process, data mining, Microsoft office tool, Quality and compliance.
  • Strong technical writing and interpersonal skills (able to influence tri functional team and organizational leads).
Employee Value Proposition:
Ability to work independently, investigate root causes, exposure to site advancements and systems.
Red Flags:
No investigations experience, only writing in SOP experience, no technical concept experience, lack of Microsoft experience.
Interview process:
Video Skype 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 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.
3KC Talent Acquisition Team

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