Manufacturing Specialist Investigator (JP10551)

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 a

Manufacturing Specialist Investigator

for 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 to

resumes@3keyconsulting.com

• . Ifyou decide that you're not interested in pursuing this position, please feel free to look at other positions on our website

www.3keyconsulting.com

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