I will be your gmp technical writer for sops and batch records

United States

I speak English

cGMP Documentation and Compliance Expert

I deliver Audit-Proven SOPs and Batch Records for Pharma/Biotech, Med. Device, and Supplements. My background is unique: I was a Bioprocessing Supervisor who oversaw compliant production and successf...

About this Gig

Need FDA-compliant cGMP documentation that passes audits? I specialize in writing clear, accurate, and fully compliant SOPs and Batch Records for the Pharmaceutical, Biotechnology, and Medical Device industries.

I don't just write compliant documents; I write operationally effective documents. With my background as a Bioprocessing Supervisor who has managed 30+ unique constructs in GMP labs, led labs through FDA audits, and served as an MES/EBR implementation consultant, I deliver SOPs and Batch Records that are not only 100% compliant but also designed for operator efficiency and seamless electronic system integration.

I can create:

cGMP Standard Operating Procedures (SOPs):

Manufacturing, Laboratory (LIMS), Equipment Operation, Cleaning, Calibration, Maintenance, Training, and more.

Master & Executed Batch Records (MBRs / EBRs):

Formulation, Filling, Packaging, Aseptic Processing, and Device Assembly.

Supporting Documentation:

Work Instructions (WIs), Forms/Templates, Logbooks, Change Control Documents.

Workflow / How It Works:

Consultation: We discuss your specific process, facility, and regulatory needs.
Drafting: I use your source materials (SME interviews, existing drafts,