Validation Author

As we continue to grow as one QuidelOrtho we are seeking a Validation Author to work in our manufacturing facility in Rochester NY. The Validation Author will be part of a project team responsible for the commissioning of a new manufacturing facility in Rochester NY. The candidate will take an active role with multiple functional teams, including, but not limited to: Operations/Manufacturing (both reagent manufacturing and analyzer assembly), Engineering, Materials Management, and Quality. The candidate will be responsible for managing change documentation for the team and assisting with process and procedure development.

This position is in Rochester, NY.

• Responsible for reviewing, editing and/or creating pharmaceutical/medical documentation (e.g. batch records, specifications, procedures, SOPs, etc.) to provide 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.

• Determine the needs of end users (manufacturing operators, formulation technicians) of technical documentation.

• Create SOPs, Batch Records, Work Instructions, Forms and associated technical documentation for manufacturing and/or lab operations.

• 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.

• Perform other work-related duties as assigned.

Required:

• A Bachelor's Degree, 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.

• Communication skills: Excellent communication skills including 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 oriented:Must be able to create detailed instructions. The instructions must be accurate with content and format details.

• Teamwork:Must be able to work within a cross functional team which may include R&D, Quality, Manufacturing, Engineering, Regulatory Affairs, and Documentation Control.

• Prioritization: Strong prioritization and multitasking skills, as well as managing one's own time.

Preferred:

• FDA regulated Manufacturing and/or Quality experience.

• Experience within the Ortho Windchill change management system/process.

Internal: Operations, Product Support, Quality, QA Incoming, warehouse, Network Planner, Demand Team

External: Suppliers

The work environment characteristics are representative of an office environment. Up to 75% of time at desk, standing or sitting extended periods of time. No strenuous physical activity, though occasional light lifting of files and related materials (up to 10 lbs.) is required. Will require domestic and international travel up to 20%. Ability to travel on short notice.

Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $80,000 to $136,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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 recruiting@quidelortho.com.

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