Manufacturing Trainer & Documentation Specialist I/II

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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The Opportunity

As Manufacturing Trainer and Documentation Specialist will assist in the development and sustainment of a comprehensive manufacturing certification program, and create and disseminate classroom/computer-based training that will include different types of training. This highly collaborative role will operate cross-functionally with R&D, Engineering and Manufacturing teams to create, revise and publish documentation for all site-relevant products, and transfer technical process documentation into manufacturing procedures. This is a dynamic career opportunity that will have an immediate impact on manufacturing quality in this high-visibility role.

• Help to develop, implement and sustain a comprehensive training curriculum and certification program for various technical processes in conjunction with subject matter experts to ensure accurate transfer of knowledge to manufacturing operators and technicians.
• Responsible for creating, administering and maintaining a training certification program for manufacturing processes, including outlines, text, visual management, handouts, tests and retraining requirements.
• Create and administer written and practical exams and evaluate trainees' performance and development on manufacturing processes.
• Ensure documentation and training is in compliance with quality systems (FDA, GMP, QSR, ISO), product specifications, process instructions, safety requirements and company policies.
• Use desktop publishing tools skillfully to produce efficient and accurate documentation.
• Create, write and edit high quality text and graphics, using easy-to-understand grammar, excellent writing structure and good punctuation.
• Collaborate and provide manufacturing input and documentation support to New Product teams, including developing/refining manufacturing instructions.

Specialist II

Additional Responsibilities

• Critique and improve accuracy and flow of technical documentation through interaction with manufacturing, engineering and R&D associates.
• Creates and administers written and practical exams and evaluates trainees' performance and development on manufacturing processes.
• Track, analyze, summarize and report key indicator data and metrics for areas of responsibility.
• Provide documentation support for various manufacturing and quality systems including NCR, CAPA, etc. as required.
• Responsible for notifying management of risks and non-conformances identified, providing recommendations for resolution and ensuring appropriate corrective and preventive actions are implemented and sustained.

Who You Are

Specialist I

• B.S. or B.A. degree in Communications, Education or a technical discipline is preferred.
• 1+ years of related experience within a highly technical manufacturing environment.
• Experience working in a clean room environment and application of environmental procedures preferred.

Specialist II

• B.S. degree in Communications, Education or a technical discipline is preferred.
• 3+ years of related experience within a highly technical manufacturing environment
• Experience working in a clean room environment and application of environmental procedures preferred.

Behaviors, competencies, and qualities of the ideal applicant.

• Subject Matter Expert in a minimum of one ePlex manufacturing process is preferred.
• Effective analytical problem solving, judgment and decision-making skills
• Exceptional writing and presentation skills; creating, administering and maintaining a training certification program a plus
• Working knowledge of quality system requirements (QSR) and good manufacturing practices (GMP).
• Experience with electronic Quality Management system is preferred

Relocation benefits are not offered for this job posting.

The expected salary range for this position based on the primary location of California is 39,100.00 - 72,700.00 USD Annual. 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.

Benefits

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.