Senior Technical Writer, Operations

Roche - Carlsbad, CA

Full-time - Mid Level

Carlsbad, CA

10,001+ employees

Chemical Manufacturing

About the position

As a Senior Technical Writer in Operations at our GenMark facility in Carlsbad, CA, you will be tasked with developing and updating equipment maintenance procedures and forms, ensuring adherence to the company's quality system standards as well as Federal and State regulations. In this role, you will collaborate closely with the manufacturing leadership, engineering, and quality assurance teams to design, assess, and document various aspects of the manufacturing process. Additionally, you will be involved in training initiatives that stem from documentation updates. Your responsibilities will include critiquing and improving the accuracy and flow of technical documentation through interaction with manufacturing. You will ensure that all work is aligned with the ISO 17025 Quality System and Safety Programs. Leading meetings related to the release of calibration documents, you will provide insightful feedback and lead discussions about needed documentation changes. You will also provide manufacturing input and documentation support to New Product teams, including developing and refining manufacturing instructions. Furthermore, you will implement and manage change orders within GenMark QMS, review and provide input on QMS documentation including validation studies, stability studies, non-conformances, and failure investigations. As a member of MRB, CO, and CAPA Boards/Teams, you will collaborate on investigations and troubleshooting, recognizing internal and external continuous improvement opportunities and driving them to the desired state.

Responsibilities

• Develop and update equipment maintenance procedures and forms.
• Ensure adherence to the company's quality system standards and Federal and State regulations.
• Collaborate with manufacturing leadership, engineering, and quality assurance teams to document manufacturing processes.
• Critique and improve the accuracy and flow of technical documentation through interaction with manufacturing.
• Lead meetings related to the release of calibration documents and provide feedback.
• Lead discussions about needed documentation changes.
• Provide manufacturing input and documentation support to New Product teams.
• Implement and manage change orders within GenMark QMS.
• Review and provide input on QMS documentation including validation studies and non-conformances.
• Collaborate on investigations and troubleshooting (e.g. CAPA, NCR, deviations).
• Recognize and drive continuous improvement opportunities.

Requirements

• B.S. degree in the sciences, life sciences, engineering, or English, or equivalent business experience.
• 5 or more years of relevant experience as a technical writer and/or process documentation specialist.
• Exceptional writing and presentation skills.
• Proven experience in developing/implementing training content for manufacturing processes.
• Familiarity with biotech and manufacturing processes and procedures preferred.
• Effective analytical problem solving, judgment, and decision-making skills.
• Working knowledge of quality system requirements (QSR) and good manufacturing practices (GMP).
• Experience working in a clean room environment and application of environmental procedures preferred.

Nice-to-haves

• ISO 17025 certification preferred.

Benefits

• Discretionary annual bonus based on individual and Company performance.
• Comprehensive health insurance coverage.
• Paid time off and holidays.
• Opportunities for professional development and training.