Job Description

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

And as the world evolves, so do we.  For over 125 years, we have taken on some of the most complex challenges in healthcare. 

The Opportunity

You as Operations Technical Writer are responsible for creating and revising manufacturing procedures and forms, and compliance to 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. 

Also, you are:

• 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 drive 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 of the ideal applicant.

• 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 clean room 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.

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.

Who we are

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’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

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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