Job Title:   Specialist Manufacturing (JP9662)
Location: West Greenwich, RI. 02817
Employment Type:  Contract
Business Unit: ARI Manufacturing Support
Duration: 7+ months (with likely extensions and/or conversion to permanent)
Posting Date: 1/12/2022
Notes: Working on site with the opportunity to work remotely in some instances.

3 Key Consulting is hiring a Specialist Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
Operations is one of three foundational functions at our client with a mission to manufacture and deliver safe and effective medicine to patients around the world. The Operations Program at the Rhode Island site is divided into five functions: Supply Chain, Process Development, Quality, Manufacturing, and Facilities & Engineering.
We are currently seeking highly motivated, hardworking individuals who will directly support Manufacturing operations in their newest Next Generation Biomanufacturing plant. Along with key business partners and functional groups, this position will focus on directly supporting manufacturing operations and new product introductions.
The primary responsibilities for this role may include, but are not limited to the following:

• Support of manufacturing operations.
• Management of Manufacturing process documentation per required process in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Initiating and owning quality records (e.g. change controls, deviations, CAPAs).

Why is the Position Open?
Additional workload on team.

Top Must Have Skills:

• GMP experience.
• Technical writing experience.
• Development of regulated or process documents with the ability to deliver high quality documentation.

Day to Day Responsibilities:

• Support of manufacturing operations.
• Management of Manufacturing process documentation per required process in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Initiating and owning quality records.

Basic Qualifications:
Bachelor’s degree in Engineering, Science or related field.

Preferred Qualifications:

• 3 or more years of experience in Cell Culture or Purification execution and/or support.
• Single use technology experience.
• Proficient on Microsoft Office Suite.
• Ability to work independently and as a team player.
• Excellent collaboration and problem solving skills.
• Ability to work virtually.
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles.
• Experience with Manufacturing execution and automation systems.
• Experience with lab equipment/testing.
• Experience in influencing and negotiation.

Employee Value Proposition:

• Great Biotech/pharma to work for.
• Grow their skillset.

Red Flags:
Inexperience in GMP and technical writing

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.