Documentation Specialist

3 weeks ago

Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full time

Must have Drug Product experience and experience creating/authoring SOPs.


This role as Manufacturing Support Associate 2 will provide reliable support to the Drug Product Manufacturing operations during the establishment of the facility and processes. This position will also support the creation of standard operating procedures, processes, trainings and documentation along with supporting tech transfer, batch planning, documentation updates and coordination of non-batch activities. This includes: Changeover, PMs, deviation management and audit preparation.

What You’ll Do

  • During the project phase, support operational readiness initiatives as well as site commissioning and qualification
  • Own and drive drug product operational readiness document plan, contribute to the preparation of standard operating processes(SOPs) and documentation packages as defined by the project plan
  • Participate in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required
  • Actively participate in establishment of batch handling processes for Drug product manufacturing
  • Execute and drive minor projects and initiate change management requests, including optimization projects
  • Lead and guide shop floor deviation investigation from initiation through closure
  • Provide training and mentor of junior level team members
  • Perform other duties as assigned


Who You Are

You have strong verbal and written communication skills. You have knowledge from operational experience with formulation, filling and visual inspection processes and production equipment. You have knowledge of cGMP from a pharmaceutical production. You have the ability to adapt in a fast-paced environment, pivot and adjust plans accordingly. You have the ability to think critically and have superior problem-solving skills. You have experience with IT Systems (Office and ERP Systems).

Basic Requirements

  • High School Diploma or GED
  • 6 years of Direct Experience


Preferred Requirements

  • Associate’s Degree in Life Sciences or Engineering + 4 years of direct experience OR
  • BA/BS in Life Sciences or Engineering + 2 years of direct experience OR
  • Military experience of equivalence
  • Prior cGMP experience from a pharmaceutical production environment
  • Preferably operational experience with formulation, filling and visual inspection processes and production equipment
  • BioWorks or BTEC Capstone cGMP coursework preferred

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