Senior GMP Documentation Lead — Operations & Compliance

Corden Pharma - A Full-Service CDMO; Boulder (CO); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance PPO/HSA

Tuition Reimbursement

Paid Parental Leave

Wellness Program

Job summary

Corden Pharma Colorado is seeking a Sr. Operations Compliance, Technical Writer to craft regulated procedures and technical documents supporting Operations and Technical Operations.

You will ensure timely, compliant delivery of SOPs, training docs, change controls, and batch records across manufacturing processes. The role requires a bachelor’s degree with 5+ years in regulatory/compliance writing, and experience in cgmp manufacturing.

Qualifications

• Bachelor's degree or 5 years related experience in regulatory/compliance documentation.
• Experience in technical writing for cGMP manufacturing.
• Background in analytical chemistry or process engineering is a plus.

Responsibilities

• Establishes and maintains relationships between Manufacturing, R&D, regulatory groups and customers related to assigned duties.
• Ensures the generation of Operations and Technical Operations documents are executed to the planned timing and quality deliverables.
• Works with departments to create documentation meeting regulatory/compliance and manufacturing requirements for CPC Colorado.
• Translates process documentation from the laboratory into CPC formatting and language; advises on detail level to meet project deliverables.
• Serves as a technical lead on documentation/projects and ensures required supporting actions are identified.
• Participates in programs to plan, execute, review, and improve document generation processes.
• Identifies opportunities to implement process improvements and facilitates updates to documentation.
• Supports and provides technical guidance on documents with other departments.
• When workload permits, assists with document generation in other departments as needed.
• Supports investigations, deviations, CAPAs, change controls, etc.
• Implements and maintains adherence to Safety, Health, & Environment, Quality, and HR policies.

Skills

Regulatory compliance

Technical writing

cGMP knowledge

Documentation leadership

Education

Bachelor's degree

Tools

MS Word

Visio

FrameMaker

Job description

Corden Pharma Colorado is seeking a Sr. Operations Compliance, Technical Writer to craft regulated procedures and technical documents supporting Operations and Technical Operations.

You will ensure timely, compliant delivery of SOPs, training docs, change controls, and batch records across manufacturing processes. The role requires a bachelor’s degree with 5+ years in regulatory/compliance writing, and experience in cgmp manufacturing.