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Specialist Manufacturing, FDA GMP (JP9456)

West Greenwich, RI · Biotech/Pharmaceutical
Job Title: Specialist Manufacturing, FDA GMP (JP9456)
Location: West Greenwich, RI

Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 11/15/2021
Note: W
orking 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 bio-pharmaceutical company.

Job Summary:

Seeking highly motivated, hardworking individuals who will directly support Manufacturing operations in client’s 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)
     
Basic Qualifications: Bachelor’s degree in Engineering, Science or related field

Top 3 Must Have Skills Sets:
  • GMP experience
  • Technical writing experience
  • Development of regulated or process documents with the ability to deliver high quality documentation
     
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:
Phone interview
One panel video Webex interview. 

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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