Job title: Documentt Controller
Job type: Temporary
Emp type: Full-time
Expertise: Administrative Support
Skills: cGMP batch records data management bioprocessing compile data data transfer
Pay interval: Hourly
Pay rate: USD $21.83
Location: GSK - R & D - King of Prussia / Upper Merion Location
Job published: 09/09/2020
Job ID: 32238
Contact email: gms@epsistaffing.com, rida@epsiworx.com

Job Description

Assignment Duration: 1 Yea

Location: Upper Merion, PA

Two (2) Postitions Available 

 

Description:

 

  • Responsible for extraction, compilation, and verification of manufacturing and product quality data. May author manufacturing data reports for Biopharm assets progressing within the R&D portfolio. Will have access to data repositories and an understanding of GMP documentation systems and requirements.

  • Coordinates activities with Development groups, including requests for manufacturing performance and product quality data. Will represent the Process Technology Department at multi-disciplinary matrix teams. Presents status updates on documentation progression at these meetings.

  • Responsible for ensuring that manufacturing campaign data, supporting information, and reports are accurate and fit for purpose to support regulatory submission authoring.

    THE SPECIFIC DUTIES OF THE ROLE/POSITION:

  • Accesses GMP data repositories to extract and compile data for publication in a controlled document system. Verifies the data against original sources and prepares data reports.

  • Prepares documents and data summaries for use in technology and knowledge transfer. May conduct data verification for regulatory submissions. Ensures that documentation is sufficient to support regulatory submission authoring.

  • Coordinates data transfer activities between various Biopharmaceutical Development and Supply groups. Represents the Process Technology Department in multi-disciplinary matrix teams. Presents results/conclusions and contributes to the decision-making process within these teams.

 

COMPETENCIES:

Knowledge, skills, and behaviors required to fulfill specific duties of Role/Position

  • B.S. Degree
  • Experience with data management software and controlled documentation systems. Proficient in MS Word and Excel.
  • Good written and oral communication skills.
  • Good organizational, collaboration, and teamwork skills.
  • Strong interpersonal skills. Reliable team player able to function within a collaborative- and team-based organization.
  • Experience in project management and delivery, including the ability to prioritize and progress courses of action.
  • Works independently with minimal to no direct supervision.


    PREFERRED COMPETENCIES:

  • Previous experience in a manufacturing role, including familiarity with batch records and electronic data systems.
  • Knowledge of cGMP requirements for documentation and data handling.
  • Experience in Bioprocessing