Job Description
This Technical Writer role supports documentation activities in a regulated pharmaceutical manufacturing environment. You will author, review, and revise a wide range of GMP documents and quality system records while partnering closely with Manufacturing, Engineering, Validation, and Quality teams. The position is based in Sacramento, CA, operates primarily on a MondayFriday day shift schedule, and is offered as a 6month contract with potential for extension or conversion. The role is ideal for a self-starter who can quickly understand complex processes, identify documentation gaps, and independently produce clear, compliant, and technically accurate documentation with minimal supervision in a fast-paced, growing organization.
Responsibilities
- Author, edit, and maintain GMP documentation, including batch records, standard operating procedures (SOPs), deviations, investigations, corrective and preventive actions (CAPAs), change controls, qualification protocols, performance qualification (PQ) protocols and reports, validation documentation, and technical and summary reports.
- Partner with Manufacturing, Engineering, Validation, and Quality teams to gather technical information and translate it into clear, concise, and compliant documentation.
- Review existing documentation and workflows to identify gaps, inconsistencies, and opportunities for process and documentation improvement.
- Ensure all documentation complies with FDA regulations, current Good Manufacturing Practices (cGMP), and internal quality and compliance standards.
- Support the execution and documentation of quality system activities within electronic quality management systems.
- Coordinate document revisions and updates based on process improvements, equipment changes, and evolving regulatory expectations.
- Maintain document control, traceability, and compliance throughout the entire document lifecycle.
- Participate in cross-functional projects and support business initiatives related to process improvements, validation activities, and organizational growth.
- Quickly assess existing processes in the GMP environment, identify documentation gaps, and develop compliant documentation with minimal training or oversight.
- Manage multiple documentation projects simultaneously while maintaining a high level of quality, accuracy, and regulatory compliance.
Essential Skills
- Bachelors degree in a scientific, engineering, or related discipline preferred.
- 3+ years of technical writing experience in a regulated industry.
- Experience authoring GMP documentation in a pharmaceutical, biotechnology, medical device, or other FDA-regulated environment.
- Strong experience writing SOPs, batch records, deviations, investigations, CAPAs, change controls, and validation and qualification documentation.
- Working knowledge of FDA regulations and current Good Manufacturing Practices (cGMP).
- Excellent written communication skills and demonstrated ability to produce clear, structured technical documentation.
- Ability to independently gather information from subject matter experts, manage priorities, and execute projects with limited direction.
- Strong attention to detail and ability to identify documentation gaps, inconsistencies, and compliance risks.
- Ability to operate effectively in a fast-paced environment and manage multiple concurrent projects.
- Target experience level of approximately 37 years in relevant technical writing and regulated environments.
Additional Skills & Qualifications
- Pharmaceutical manufacturing experience strongly preferred.
- Experience supporting validation and qualification activities, including protocols and reports.
- Familiarity with electronic quality management systems (QMS).
- Experience in company integration, process improvement, or documentation remediation projects is a plus.
- Demonstrated ability to quickly understand complex manufacturing and validation processes in a GMP environment.
- Organized, proactive, and comfortable working with cross-functional teams.
- High level of independence, ownership, and execution in managing documentation responsibilities.
