Quality Technician 1
|Organization:||Ortho Clinical Diagnostics|
The Company: Ortho Clinical Diagnostics (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company is a strong, highly competitive organization with approximately 3,800 employees worldwide, and sales, marketing and logistics on six continents. OCD was recently acquired by the Carlyle Group, a highly respected global asset management company, as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide. The Career Potential: We are committed to enabling diagnostics to fulfill its vital role in the continuum of care and its importance as the focus of healthcare changes from treating sickness to promoting wellness. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. You will have access to a broad and exciting array of experiences, opportunities and new directions at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
The Opportunity: As the company transitions, we are seeking a Quality Technician I in Quality Operations located in Rochester NY. You will be responsible for assessing the completion and adequacy of the Device History Record (DHR) to support the release of customer product. The Responsibilities: * Reviews Device History Record (DHR) data entries for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records. * Records and escalates exceptions to DHR in the applicable quality management systems. * Performs QA Review and Releases product through a final usage decision in SAP so that the product can be shipped for customer use. * Maintains a record of DHR errors and generates nonconformance’s when necessary to alert Quality Engineers and other applicable personnel of any issues. * Assists with the implementation of revisions, corrections and changes to procedures and methods. * Observes discussions with quality, engineering and other relevant departments to learn about corrective actions for reoccurring problems. * Ability to summarize data and coordinate with manufacturing supervisors the efficienttimely release of product. * Observes and participates in discussions with quality, engineering and other relevant departments to learn about corrective actions for recurring issues. * Must be detail oriented having the ability to work both independently and as a part of a dynamic team. * Follows detailed procedures documented in SOP's, work instructions, forms and on check lists. * Strong documentation and organizational skills are required.
* Requires a minimum of a High School Diploma or GED and 2 years related work experience, preferably in a regulated environment. * Strong communication skills, both verbally and written is required. * Ability to follow detailed procedures documented in SOP's, work instructions, forms and on check lists. Follows compliance requirements and has knowledge of GMPs. * Microsoft Office (Outlook, Word, Excel, Access). * Strong attention to detail * Ability to work in a highly matrix organization * Must be a highly flexibly individual who can work well in an environment with defined production deadlines * Preferred competencies include: SAP experience * ASQ or industry related certifications, QERTS Experience, LIMS Experience, and OTIS Change Author Experience. * Knowledge of blood analyzer equipment is preferred. * Ability to be flexible in covering manufacturing shift hours * Process Excellence knowledge is preferred. Join us on the Journey Let’s get started Apply today or refer a friend.