Quality Document Manufacturing Specialist - Talent Groups : Job Details

• Bachelor's degree in Engineering or Life Sciences.
• Minimum of 5+ years of Pharma manufacturing industry experience.

Strong knowledge of biologics drug substance production, including:

• Cell banking, plasmid production, and gene therapy BDS.
• Cell culture, chromatography, TFF (tangential flow filtration), and aseptic techniques.

Proven experience with quality systems documentation, including:

• Deviations, change controls, batch records, and technical reports.
• Demonstrated ability to work independently and deliver results with minimal supervision.
• Skilled in managing multiple competing priorities in a dynamic, fast-paced environment.
• Exceptional communication skills, both written and verbal.
• Project management or collaboration with CDMOs (Contract Development and Manufacturing Organizations).