QA Analyst 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 Quality Assurance Analyst II. The Quality Analyst II is primarily responsible for reviewing batch records and releasing biological products according to established procedures or approved protocols.

This position is in Pompano Beach Florida.

Schedule: This is primarily a 1st shift position

The Responsibilities

• Completes batch record review at various stages (i.e. Formulations, Stage 4 Release Testing, Filling/Label Pack BTR’s) of the manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met.

• Prepares CBER protocols per procedure and sends to FDA via ESG portal.

• Issues manufacturing and formulation batch record according to the production/formulation schedule.

• Identify batch record issues and open non-conformances where required in QMS.

• Responsible for product dispositions.

• Performs records coordinator activities in support of quality record retention on-site and off-site according to quality system procedures.

• Trains other employees.

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor’s degree or equivalent and 2-4 years of experience at a medical or manufacturing facility; or equivalent combination of education and experience

• Knowledge of 21CFR Part 820, cGMPs, and ISO 9001 standards.

• Demonstrates an attention detail; ability to stay focused on the task at hand for long periods of time.

• Ability to demonstrate flexibility and adaptability; ability to prioritize within a changing business environment.

• Ability to work both independently and within a team environment.

• Ability to effectively communicate; demonstrate a sense of urgency to complete production schedule on time; accepts personal responsibility for the quality and timeliness of work

Preferred:

• Bachelor’s degree in Medical Technology or Science.

• Knowledge of Quality Information Systems (Windchill, ERP/SAP, Lab Investigations).

• Computer skills i.e. Microsoft Office (Word, Excel, Outlook).

• Be an advocate for a safe work environment and be responsible for my safety and the safety of others.

The Key Working Interactions

Internal: Material Management, Quality, Formulations, EHS, Facilities, Engineering, Product Support are necessary to drive effective prioritization and collaboration to meet the needs of the business.

External: N/A

The Work Environment

• Workspace: on-site

• Protective equipment

• Biohazard

The Physical Demands

• Continuous Sitting

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 r[email protected].

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