Über
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 recruiting@. #LI-SP1
Sprachkenntnisse
- English
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