Manufacturing Specialist Investigator; JP

Position: Manufacturing Specialist Investigator (JP10551)
Location: West Greenwich
Job Title
:
Manufacturing Specialist Investigator (JP10551)
Location:West Greenwich Rhode Island (Hybrid)
Employment Type
:
Contract
Duration
: 6 months with likely extensions
Job posting date
: 7/14/2022
Note:This is a hybrid role (Onsite and remote)

3 Key Consulting is hiring aManufacturing Specialist Investigatorfor a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
Operations is currently seeking a Manufacturing Specialist Investigator (External worker) in our site Investigation group. In support of companies mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug Substance Operations to ensure supply and to optimize the patient experience. The Manufacturing Specialist Investigator - conducts technical investigations from our 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.

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)

Ideal Candidate:
Previous client Experience
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

Top Must have Skill Sets:

• 2+ years of proven ability in investigation process
• Strong technical writing
• Proven Six Sigma proficiency specifically for root cause analysis methodology
• Understanding and application of Drug Substance process, data mining, quality and compliance.

Day-To-Day Responsibilities:
Manage investigation process such as coordinating meetings, gathering evidence, data mining, performing interviews

Employee Value Proposition:
Growth, opportunity, experience

Red Flags:
No previous experience in drug substances or investigation process

Interview Process:
1-2 panel interview

We invite qualified candidates to sendyour resume  Ifyou decide that you’re not interested in pursuing this position, please feel free to look at other positions on our  You are welcome to also sharethis posting with anyone you think might be interested in applying for this role.
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