Senior GMP Compliance Technical Writer - Documentation Lead

CordenPharma International; Boulder (CO); Hybrid; USD 94,000 - 117,000; Full time

Benefits offered by this job

401(k) matching

Critical Illness

Disability Insurance

Employee Assistance Program

Flexible Spending Account

Health Insurance PPO/HSA

Hospital Indemnity Plan

ID Theft

Life Insurance

Tuition Reimbursement

Wellness Program

Job summary

CordenPharma Colorado is seeking a Sr. Operations Compliance, Technical Writer to author and maintain procedures, training materials, and change controls in support of Operations and Technical Operations.

The role ensures timely, compliant document delivery to internal users, customers and regulatory bodies, while collaborating with Manufacturing, R&D and QA teams to meet cGMP standards.

Qualifications

• Bachelor's Degree in a related field or 5 years of experience in regulatory/compliance and cGMP documentation.
• Experience writing regulatory/compliance documentation for manufacturing environments.
• Previous technical writing role recommended in pharma or similar industry.

Responsibilities

• Author and maintain procedures, training docs, change controls, risk assessments, and batch records.
• Ensure documents are delivered on time, compliant, and meet quality standards.
• Collaborate with Manufacturing, R&D, regulatory and external customers on documentation needs.
• Translate laboratory or customer documents into CPC formats and language for manufacturing.
• Lead documentation projects and drive process improvements in writing workflows.
• Support investigations, deviations, CAPAs, and change controls as needed.
• Adhere to SHE, Quality, and HR policies in all documentation work.

Skills

Communication skills

Regulatory knowledge

Technical writing

Project coordination

Cross-functional collaboration

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Visio

Adobe FrameMaker

Job description

CordenPharma Colorado is seeking a Sr. Operations Compliance, Technical Writer to author and maintain procedures, training materials, and change controls in support of Operations and Technical Operations.

The role ensures timely, compliant document delivery to internal users, customers and regulatory bodies, while collaborating with Manufacturing, R&D and QA teams to meet cGMP standards.