Quality Operations Analyst

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

The Quality Operations Analyst supports activities in the Quality Operations department as defined by the Quality Management System (QMS) and within defined company policies, procedures and regulatory requirements. The position will address a wide range of functional needs, requiring close interaction with various individuals on issues involving the development and maintenance of the QMS, including carrying out complex daily operations related to non-conformance function and CAPA processes. As an integral part of the QO department; active participation in the planning of quality programs is required. The position is involved with the administration of various key QO programs and developing related analytics as described below to include other processes as appropriate.

This role will be located onsite in Carlsbad, CA.

The Responsibilities

• Manages complex non-conformance and Corrective Action/Preventative Action (CAPA) reports, including conducting complex investigations.

• Develops and maintains metrics associated with the Corrective Action/Preventive Action (CAPA) process.

• Responsible for using internal systems to perform transactions and verifying product information.

• Works with process owners to address CAPA issues and to monitor adherence to CAPA schedules and ensures completeness of the non-conformance and CAPA files.

• Participates in internal and external audits as required.

• May assist in assuring Quality System compliance in conformance to required standards (FDA, ISO/EN, CMDR, etc.) through the administration of the training program in Master Control and ensuring Quidel Ortho employees are meeting training levels through the development of reports and metrics and providing these data to management through Management Review.

• Performs analysis of current and new Quality System procedures and processes to ensure compliance with relevant standards and regulations.

• May assist in harmonizing Quality System programs across various Quidel Ortho business sites, ensuring that appropriate personnel at each site are engaged in harmonization efforts to include coordinating planning schedules and advising QO management on team and harmonization progress.

• Develops and maintains metrics that may be for weekly, monthly, annually trending report and management review meetings and performs analysis in support of Management Review and monthly Operations meetings, as related to QO processes specifically for change control, internal audits, customer complaints, corrective and preventive actions, and other areas as deemed necessary.

• Supports department personnel in achieving objectives in support of the vision and mission of the corporation and department.

• Carries out other duties in compliance with established business policies.

• Performs other duties and projects as assigned.

The Individual

Required:

• Bachelors (BS/BA) or Associates Degree in Engineering/Chemistry/Biology/technical discipline/Business Management or equivalent combination education and/or work experience

• 3+ years of related progressive responsibility and experience

• Must be highly skilled in typical computer systems and software including proficiency in MS Office, suite and Adobe programs

• Professional demeanor and team-oriented attitude

• Ability to work quickly and efficiently with detail and accuracy

• Results-driven; high sense of urgency and initiative

• Ability to work independently and be able to prioritize numerous duties

• Excellent verbal and written communication skills

• Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment

• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA, and other regulatory agencies

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

Preferred:

• Experience in Quality Systems/Quality Control in Pharmaceuticals, Medical Device and/or IVD manufacturing environment

• Working knowledge of FDA Quality System regulation and ISO standards

• Experience supporting numerous aspects of operations in Quality Assurance and/or Quality Control

• 6-Sigma experience

The Key Working Relationships

Interacts with peers and various management levels across departments to ensure quality compliance. Interaction normally requires the ability to gain cooperation of others. Interacts in activities such as document creation or revision with internal customers and corporate partners on QMS compliance and support. May participate in support of QO Management in the hosting of audits by external parties on matters relating to the QMS.

The Work Environment

The work environment characteristics are representative of both an office and manufacturing environment.

The Physical Demands

Ability to use a computer, manipulate a keyboard and communicate/operate within a team environment. Must be able to visually monitor products for Quality Standards. Must be able to lift a minimum of 20 pounds.

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 $75,000 - $85,000 annually. 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 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 [email protected].

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