QA Analyst II

QuidelOrtho • Pompano Beach, FL

20h • Onsite

About The Position

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.
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

Requirements

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

Nice To Haves

• 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).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level