Technical Writer II

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Technical Writer II in Rochester, NY. The Technical Writer II will be part of the engineering team responsible for the modification of production lines and commissioning of equipment in Rochester NY. This position will be responsible for managing change documentation for the team and assisting with process and procedure development. The candidate will assess risks and will drive quality related decisions. Tracking, monitoring, and engaging engineers on tasks required by quality.

This position is in Rochester, NY.

Responsibilities

• Responsible for reviewing, editing and/or creating pharmaceutical/medical/technical documentation (e.g. batch records, specifications, procedures, SOPs, work instructions, forms etc.) for manufacturing and lab operations, providing clear and correct instructions for site processes and procedures.
• Interview and confer with SMEs in cross functional groups, observing production, developmental, and experiment activities to develop and/or revise documentation content for completeness and correctness.
• Edit, standardize, or make changes to documents prepared by SMEs or other company personnel.
• Use Microsoft Word for editing and/or creating documents and demonstrating proficiency with templates and custom formats. Ensure verbiage is easy for manufacturing operators and formulation technicians to understand.
• Review established documentation and recommend revisions or changes in scope, format, and content.
• Provide direction with the use of best practices for documentation hierarchy during documentation creation process.
• Write document change documentation within a computer-based change management software (WindChill).
• Maintain records and files of work and revisions.
• Develop specific goals and plans to prioritize, organize, and accomplish objectives.
• Manage the documentation, change order, and change control processes.
• Manage new documentation and revised documentation through lifecycle within a document management system.

The Individual

Required:

• A Bachelor's Degree is required, preferably with an educational background in Science, Engineering, Manufacturing.
• Minimum 5 years of experience technical writing and/or procedure development. A combination of education and experience may be considered.
• Proficiency Microsoft Office (Word Required: Excel and Visio Preferred).
• Strong knowledge of English language including the meaning and spelling of words, rules of composition, and grammar.
• Detail orientated: Must be able to create detailed instructions.
• Strong prioritization, multitasking, and time management skills.
• Excellent communication skills; verbal and written.

Preferred:

• FDA regulated Manufacturing and/or Quality experience.
• Experience within the Ortho Windchill change management system/process.

Key Working Relationships

Internal Partners: Manufacturing Operations Supervisors and Managers, Cell Leaders, Site Administrative Support Personnel, Quality, Engineering , Operations and Maintenance team members.

External Partners: Suppliers

Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time you will be, standing, walking or sitting for extended periods of time. Ability to lift up to 50 lbs. Flexible work hours to meet project deadlines.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected]

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