SAM's Senior Manager Manufacturing

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.

As we continue to grow as one QuidelOrtho, we are seeking a SAM's Senior Manager Manufacturing to work in our slides manufacturing facility. The SAM's Senior Manager Manufacturing will work under minimal supervision, this position is responsible for management of the Slide Assemble production departments and personnel by providing guidance, training and leadership on a daily basis. Position may be part of multi-shift supervisor team empowered to manage 24 x 7 manufacturing operations.

This position is in Rochester, NY.

• Provide input to the crew supervisors on employee performance and model/recognize/reward the preferred culture and drive accountability within SAMs.

• Minimize Waste and closely monitor MUV and Contribute to Productivity goals.

• Ensures Production and Safety standards are adhered to, and Supervisors are completing their standard work. Standard work across the crews.

• Establishes manufacturing policies and procedures.

• Lead daily update meetings within the cell and coordinate communications to ensure alignment across shifts for awareness and action. Implement, monitor, and improve OEE measures and assure compliance to all operations and maintenance procedures.

• Develops and recommends project objectives, timelines, and resources, and prepares cost estimates. Implements the agreed upon projects on time.

• Manages departmental budget 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. Ensure robust training is implemented across the crews.

• 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.

Required:

• High School Diploma.

• Eight years of experience in manufacturing required, preferably in the biotechnology industry.

• 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.

• Awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Preferred:

• Bachelor's degree in production, life science or equivalent or a combination of courses and experience.

• Four years of experience in a management position overseeing supervisors and staff.

Internal: R&D, Supply Chain, Quality, Planning, Facilities

External: Suppliers

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.

Position requires ability to lift up 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.

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 $99,000 to $168,000 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.

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 orthorecruiting@orthoclinicaldiagnostics.com

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