GMP Manufacturing Technical Writer

Rentschler Biopharma Inc.; Milford (CT); On-site; USD 52,000 - 69,000; Full time

Job summary

Rentschler Biopharma Inc. in Milford, MA seeks a Manufacturing Technical Writer to create, revise and manage GMP documentation for upstream manufacturing processes.

You will own MPRs, batch records, SOPs and work instructions to ensure accuracy and on-time implementation. You will lead documentation workflows within quality systems and partner with Manufacturing Operations, MSAT, Process Engineering, Quality, and Training teams to keep documentation current and properly trained for production

Qualifications

• 5+ years of experience in manufacturing, quality & compliance.
• Author of GMP and technical documentation for new and existing processes (SOPs, batch records, training docs).
• Experience with quality documentation systems (MasterControl, TrackWise).
• Self-initiator, strong collaborator, able to track status and meet deadlines.

Responsibilities

• Generate, revise, and manage Upstream Master Production Records (MPRs) and GMP docs with accuracy and on-time implementation.
• Serve as the documentation lead for upstream manufacturing processes, including cell culture operations and bioreactor systems.
• Own document workflows in quality systems: creation, routing, review, approval, revision control, implementation.

Skills

5+ years in manufacturing quality &amp

Author of GMP/technical docs

Quality documentation systems

Self-starter, collaborative

Education

Bachelor's degree in a relevant field

Biopharmaceutical GMP experience

Tools

MasterControl

TrackWise

Job description

Rentschler Biopharma Inc. in Milford, MA seeks a Manufacturing Technical Writer to create, revise and manage GMP documentation for upstream manufacturing processes.

You will own MPRs, batch records, SOPs and work instructions to ensure accuracy and on-time implementation. You will lead documentation workflows within quality systems and partner with Manufacturing Operations, MSAT, Process Engineering, Quality, and Training teams to keep documentation current and properly trained for production