Manager, Production

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 Manager in Production to forecast and budget all managing activities in the manufacturing areas including coordinating planning and scheduling efforts in support of the master production schedule for all products and processes; maximum utilization of resources by ensuring effective use of employee skills, equipment, materials and systems; compliance with established quality systems and measurements. These responsibilities include financial accountability to manufacturing standards, yields, scrap, workforce, and management of the work order process.

This role will be 2nd shift from 2:00pm - 10:30 PM PST in our Carlsbad, Ca location.

The Position

• Responsible for managing and monitoring assembly preparation, device assembly, meter preparation and calibration, and/or packaging areas.
• Establishes manufacturing policies and procedures.
• Develops and recommends project objectives, timelines, and resources, and prepares cost estimates.
• Manages departmental budgets and spending.
• Uses problem analysis techniques to resolve production-related, technical, regulatory, quality, and supply issues.
• Represents the department or leads cross-functional teams aimed at resolving issues and implementing projects.
• Reviews complaints and suggestions and recommends methods or techniques for improvement.
• Ensures personnel are trained and qualified in manufacturing procedures.
• Demonstrates commitment to the development, implementation, and effectiveness of Quidel's GMP, LEAN, and Safety programs.
• Ensures compliance with FDA, ISO, OSHA, and other regulatory agencies.
• Manages performance of staff towards department and Company goals, including but not limited to feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance.
• Carries out duties in compliance with established business policies.
• Performs other duties & projects as assigned.

The Individual

Required:

• High School Diploma required.
• Bachelor's degree in production, life science or equivalent or a combination of courses and experience preferred.
• Eight years of experience in manufacturing required, preferably in the biotechnology industry.
• Four years of experience in a management position overseeing supervisors and staff highly preferred
• Excellent skills in MS Office (MS Word/Excel)
• Excellent Good Manufacturing Practice (GMP) knowledge
• Experience in understanding and adhering to manufacturing documentation and completing manufacturing documentation.
• Experience in managing the operation of equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations.
• Strong technical writing and analytical skills required to write investigative reports, SOPs, NCMRs, batch records and other production-related documents.
• 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

The Key Stakeholders

Internal Partners:

• R&D, Supply Chain, Production Managers, Process Engineers, Quality Engineers, Director of Manufacturing, Planning, Cost Accounting, Facilities, and Engineering.

External Partners:

• Contractors and vendors.

The Work Environment

The work environment characteristics are representative of office, laboratory, and manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples. Flexible work hours to meet project deadlines.

Physical Demands

Position requires ability to lift to30 lbs. onoccasion.Up to 60% of time in meetings, working with team and on the manufacturing floor; 40% of the time at the desk on computer, walking, standing or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role.Specific vision abilities required by this job include close and distance vision and the ability to adjust focus.Position requires use of Personal Protective Equipment as posted.

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 $110,000-$130,000[and is bonus eligible or eligible for incentive compensation.] 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 the 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.