Technical Writer, Operations Job at F. Hoffmann-La Roche AG in Carlsbad

Technical Writer, Operations

Technical Writer, Operations

Locations: Carlsbad

Time Type: Tempo integral

Posted On: Publicado há 3 dias

Time Left to Apply: Data de término: 6 de janeiro de 2025 (16 dias restantes para se candidatar)

Job Requisition ID: 202411-130438

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

You, as Operations Technical Writer, are responsible for creating and revising manufacturing procedures and forms, and compliance with the company’s quality system requirements and Federal/State regulations. You will work closely with the manufacturing leadership team, engineering team, and quality assurance to design, evaluate, and document multiple facets of the manufacturing process.

Responsibilities:

• Critiquing and improving accuracy and flow of technical documentation through interaction with manufacturing. Scheduling and leading discussions about documentation changes.
• Collaborating and providing manufacturing input and documentation support to New Product teams, including developing/refining manufacturing instructions.
• Implementing and managing change orders internally.
• Collaborating on investigations and troubleshooting (e.g. CAPA, NCR, deviations).
• Reviewing and providing input on QMS documentation including, but not limited to, validation studies, stability studies, non-conformances, and failure investigations.
• Finding and applying continuous improvement opportunities and driving them to the desired state.

Who You Are:

• You have a B.S. or B.A. degree in the sciences, life sciences, engineering, or English, or equivalent business experience.
• 2+ years of relevant experience as a writer and/or process documentation specialist.

Preferred Behaviors, Competencies, and Qualities:

• Exceptional writing and presentation skills with proven experience in developing/implementing training content for manufacturing processes.
• Familiarity with biotech and manufacturing processes and procedures including acceptance activities and process controls, identification and traceability, quality auditing, etc.
• Working knowledge of quality system requirements (QSR) and good manufacturing practices (GMP).
• Experience working in a cleanroom environment and application of environmental procedures.

Work Environment:

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens, and automated equipment.

Relocation benefits are not offered for this job posting.

Salary: The expected salary range for this position based on the primary location of California is $55,100.00 - $101,800.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

About Us

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools, and services that help in the prevention, diagnosis, and management of diseases like HPV, HIV, hepatitis, and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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