Roche Holdings Inc.
Senior Technical Writer, Operations
Roche Holdings Inc., Carlsbad, California, United States, 92009
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 full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.The Position A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.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.The Opportunity
Critique and improve accuracy and flow of technical documentation through interaction with manufacturing. Ensures all work is aligned with the ISO 17025 Quality System and Safety Programs.
Lead meetings related to the release of calibration documents, providing insightful feedback. Lead discussions about needed documentation changes. Provide manufacturing input and documentation support to New Product teams, including developing/refining manufacturing instructions.
Implement and manage change orders within GenMark QMS. Review and provide input on QMS documentation including, but not limited, validation studies, stability studies, non-conformances, and failure investigations. Member of MRB, CO, and CAPA Boards/Teams, as assigned.
Collaborate on investigations and troubleshooting (e.g. CAPA, NCR, deviations).
Recognize internal and external continuous improvement opportunities and drives them to the desired state.
Who you are
B.S. degree in the sciences, life sciences, or engineering or English, or equivalent business experience with 5 or more years of relevant experience as a technical writer and/or process documentation specialist. Equivalent combination of education and experience may be substituted for Bachelor's degree.
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. 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.
Relocation benefits are not available for this posting.The expected salary range for this position based on the primary location of Carlsbad, CA is $69,900-$129,900. 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.BenefitsWho 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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The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.The Position A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.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.The Opportunity
Critique and improve accuracy and flow of technical documentation through interaction with manufacturing. Ensures all work is aligned with the ISO 17025 Quality System and Safety Programs.
Lead meetings related to the release of calibration documents, providing insightful feedback. Lead discussions about needed documentation changes. Provide manufacturing input and documentation support to New Product teams, including developing/refining manufacturing instructions.
Implement and manage change orders within GenMark QMS. Review and provide input on QMS documentation including, but not limited, validation studies, stability studies, non-conformances, and failure investigations. Member of MRB, CO, and CAPA Boards/Teams, as assigned.
Collaborate on investigations and troubleshooting (e.g. CAPA, NCR, deviations).
Recognize internal and external continuous improvement opportunities and drives them to the desired state.
Who you are
B.S. degree in the sciences, life sciences, or engineering or English, or equivalent business experience with 5 or more years of relevant experience as a technical writer and/or process documentation specialist. Equivalent combination of education and experience may be substituted for Bachelor's degree.
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. 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.
Relocation benefits are not available for this posting.The expected salary range for this position based on the primary location of Carlsbad, CA is $69,900-$129,900. 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.BenefitsWho 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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