Validation Author

QuidelOrtho • Rochester, NY

3d • $89,000 - $104,000 • Onsite

About The Position

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 QuidelOrtho is seeking a Validation Author. Th e Validation Author will provide leadership and technical support to Quality and Operations staff on all aspects of the manufacturing and laboratory process controls by establishing and communicating requirements for validation execution and documentation at the Rochester site. The candidate will participate in the creation and review of validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities. The candidate will work with Quality and Operations to ensure good manufacturing and laboratory practices are implemented and will utilize statistical tools, sampling methodologies, and validation practices to support validation activities. The individual will work closely with cross-functional teams to ensure delivery of system solutions by assuring validation activities are conducted in accordance with regulations and Ortho’s validation policies and procedures. This position will be onsite in Rochester, NY.

Requirements

• B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.
• 5-7 years of experience in Quality in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer).
• Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis.
• Required travel: Less than 10%

Responsibilities

• Provide validation support on process, equipment, software, and facilities changes while ensuring the validation and qualification activities are consistent with regulations and Ortho’s validation policies and procedures.
• Generate, review, and approve documentation supporting validation activities (plans, protocols, reports, technical documents, pFMEAs).
• Execute functions needed to support change control activities and document management requirements by collaborating with business partners and peers to define validation and change control activity requirements.
• Support validation lifecycle by developing and maintaining validation work center papers and supporting revalidation assessments and associated activities.
• Support and participate in inspection readiness activities and internal / external audits by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.
• Participate in process mapping/process analysis and in the preparation of risk assessments to support investigations and implementation of process and equipment changes.
• Participate in the creation and evaluation of statistical sampling plans and rationale to support product specifications and validation protocols.
• Provide recommendations for amendments to sampling plans to ensure appropriate product control plans are in place.
• Mentor and train junior validation engineering staff in application of validation procedures and requirements.
• Provide coaching, training, and guidance to business partners in all aspects of validation.
• Perform other work-related duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees