Upstream GMP Documentation Specialist - Biopharma

Rentschler Biopharma, Inc.; Milford, Northern (MA, KY); Híbrido; USD 108 886 000 - 143 270 000; Tempo integral

Resumo da oferta

Rentschler Biopharma, Inc. in Milford, MA is seeking a Manufacturing Technical Writer on a 6+ month contract.

The role focuses on creating, revising GMP documentation including MPRs, batch records, SOPs and work instructions for upstream processes. You will own document workflows, ensure accuracy and on-time delivery, and collaborate with Operations, MSAT, Process Engineering, QA and Training to align training with documentation changes.

Qualificações

• Bachelor’s degree in a related field.
• 5+ years in manufacturing, quality and compliance.
• Experience authoring GMP and technical documents (MPRs, SOPs, batch records).

Responsabilidades

• Generate, revise, and manage GMP documentation for upstream manufacturing.
• Own document workflows within quality systems and ensure on-time implementation.
• Collaborate with Manufacturing Operations, MSAT, Process Engineering, QA and Training teams.

Conhecimentos

GMP documentation

Cross-functional collaboration

Quality & compliance

Documentation authoring

Formação académica

Bachelor’s degree in a related field

Ferramentas

MasterControl

TrackWise

Descrição da oferta de emprego

Rentschler Biopharma, Inc. in Milford, MA is seeking a Manufacturing Technical Writer on a 6+ month contract.

The role focuses on creating, revising GMP documentation including MPRs, batch records, SOPs and work instructions for upstream processes. You will own document workflows, ensure accuracy and on-time delivery, and collaborate with Operations, MSAT, Process Engineering, QA and Training to align training with documentation changes.