- Communicate and elevate critical business-related issues, as well as opportunities to management.
- Review and approve drug and device history records to include:
- Verification of technical accuracy.
- Compliance to Specifications/Requirements, Quality System Regulations and GMPs.
- Compliance with Ortho processes and procedures.
- Ensure product meets all the criteria prior release to CBER/TUV and/or to customers.
- Recommend final dispositions of product and perform product release in inventory system.
- Identify and follow up with Operations, Quality Engineering and QA on product quality/batch release discrepancies. Determine and recommend corrective action required. Close out PD records.
- Prepare and verify accuracy of Certificates of Analysis and CBER protocols. Prepare and submit documents for TUV lot approval.
- Measure and analyze quality and process metrics for trending and quality and productivity reviews. Report unusual trends to department and Operations Management. Identify areas of improvements, propose resolution to problems and participate/lead investigation/improvement projects. Participate and contribute to intradepartmental project teams. Attend daily planning meetings and provide release updates.
- Participate in training for team members or external associates (Manufacturing and QA). Review and revise master device history records, manufacturing batch records, standard operating procedures and process documents.
- Support investigations for customer complaints by performing batch review of impacted area.
- Provide internal and external audit support.
- Make decisions on the management of workflow to meet production deadlines.
- Perform other work-related duties as assigned.
- High School Diploma or GED equivalent required; Associates Degree or Bachelor's Degree in Med Tech, Engineering or Science is preferred.
- 2 years of experience with technical documentation, SOPs, and metrics creation. Quality Experience preferred.
- Ability to analyze large volumes of data.
- General understanding of medical/biological terminology.
- Proficient in Microsoft Excel and general computer aptitude
- Up to 10% travel – domestic and/or international when necessary.
- Typical office/desk environment.
Quality Analyst II - Raritan, United States - QuidelOrtho
Description
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 Analyst II who will be responsible to provide product quality support to Ortho in product manufacture, validation, product-related projects and investigations. Will ensure quality systems activities and site projects are executed in compliance with Ortho policies and procedures and applicable regulations and standards (e.g. QSR, CMDR and other international regulations per product, ISO 13485 standard, 21 CFR 200's). This position is in Raritan, NJ.
The Responsibilities
The Individual
Required:
The Key Working Relationships
Internal Partners:
Coordination with Manufacturing and Product Support during NC/RCI/CAPA processes and project execution. Partner with Laboratories during OOS and OOT investigations; coordinate with Planners in support of product release
The Work Environment
Salary Transparency
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 that facts and circumstances of each case. Salary range for this position is $67,000 to $114,000 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
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