Qa Analyst I

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 QA Analyst I who will be responsible for reviewing batch records and releasing biological products according to established procedures or approved protocols.
This is an onsite role in our Pompano Beach, FL location.
The Responsibilities

• Completes batch record review at final stage of manufacturing process with minimal assistance and approves their final release once it has been determined that all compliance and procedural requirements have been met.
• Issues manufacturing batch records according to the production schedule.
• Identifies batch record issues and opens non-conformances where required.
• Coordinates with Manufacturing Associates for completion/correction of DHR errors.
• Collaborates with QC Lab and Microbiology teams.
• May interact with regulators.
• Leads and participates in assigned projects.
• Occasional overtime may be required.
• Performs other duties & projects as assigned.

The Individual

• Bachelor's Degree in Science with 0-2 years of experience at a medical or manufacturing facility; or a minimum of a High School Diploma/GED with 3-5 years' experience in a medical or manufacturing facility. Will consider equivalent combination of education and experience.
• Ability to demonstrate flexibility and adaptability; ability to prioritize within a changing business environment.
• Demonstrates attention to detail; ability to stay focused on the task at hand for long periods of time.
• 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.
• Basic computer skills i.e. Microsoft Office (Word, Excel, Outlook).
• Ability to work both independently and within a team environment.
• Ability to advocate for a safe work environment and take responsibility for your own safety and the safety of others.
• Knowledge of 21CFR Part 820, cGMPs, and ISO 9001 standards.
• Knowledge of Quality Systems (Trackwise, OTIS, Windchill, SAP, Lab Investigations).

Key Working Relationships

• Internal: Material Management, Quality, Formulations, EHS, Facilities, Engineering, Product Support.
• External: May interact with auditors.

The Work Environment

• Combination of operations and desk environment.

Salary Transparency
The 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 the facts and circumstances of each case. The salary range for this position is $45,000 to $81,000 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.
Equal 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 recruiting@quidelortho.com.
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