Manufacturing Documentation Specialist
Posted on 3/30/2024
INACTIVE
AGC Biologics

1,001-5,000 employees

Customized biopharmaceutical production and development services
Company Overview
AGC Biologics stands out as a global leader in the biopharmaceutical Contract Development and Manufacturing Organization (CDMO) sector, offering specialized services for the scale-up and cGMP manufacture of protein-based therapeutics and other complex biologics. The company's proprietary CHEF1™ Expression System for efficient protein production, coupled with its commitment to delivering reliable and compliant drug substances, underscores its technical prowess and competitive edge. With cGMP-compliant facilities across the US, Europe, and Japan, AGC Biologics not only ensures global reach but also fosters strong partnerships with customers, aiding them in accelerating their projects and managing product lifecycle costs.
Biotechnology

Company Stage

N/A

Total Funding

$613M

Founded

2001

Headquarters

Bothell, Washington

Growth & Insights
Headcount

6 month growth

4%

1 year growth

9%

2 year growth

21%
Locations
Seattle, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Bioinformatics
Computational Biology
Biology Lab & Research
Biology & Biotech
Requirements
  • BS degree in Biology, Chemistry or other relevant discipline or equivalent work experience
  • 0-2 Years Experience in GMP Environment
Responsibilities
  • Performs independent review of GMP documentation and partners with others for corrections
  • Coordinates with Manufacturing and Quality to complete corrections for API release
  • Reviews executed manufacturing batch records for completeness, compliance, and accuracy
  • Accesses systems including Unicorn, BMRAM, AX, and others to retrieve data for batch record completion
  • Obtains information from logbooks and assists with GMP logbook review
  • Participates in MFG operations meetings and gives updates pertaining to batch record review and deviations
  • Supports additional projects including data gathering, utilizing trackers, scanning records as needed
  • May participate in side projects related to continuous improvement efforts