Job Title: Process Improvement Specialist
Effective Date /
Last Modification Date: 08MAR2018
Responsible for leading department quality investigations to determine root cause and CAPA. Proactively leads quality improvements for the department..
Responsible for conducting investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Responsible for leading the RAPID process including initial response, containment, root cause investigation and determining appropriate CAPA. Responsible for writing the investigation reports in Trackwise (Quality System). Responsible for leading RFM huddle process to achieve timely deviation and CAPA closure to meet departmental goals Proactively drives quality improvements to achieve department RFT and quality compliance goals. Participates in inspection readiness activities and may also be involved in audits and inspections by regulatory agencies. Models effective and constructive communication and interactions with technical departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills. Requires a passion for problem solving, attention to detail, good organizational skills, a sound understanding of cGMPs and Manufacturing/ Packaging. Requires interaction with the operations personnel, QA GMP Services, Process Engineers, Records/Release, Quality Control, QA Regulatory, Engineering, and Clients. Position requires flexibility at times to complete interviews/investigations with night and end of week shifts. Escalates critical events and investigation findings to Production and Quality Assurance Management. May represent the production department on various project teams such as validation, engineering phase review meetings, and daily department communication meetings. May also assist in developing and maintaining various quality and training systems and programs.
Bachelors Degree in Engineering or Related Field is required.
Quality, process and manufacturing investigation and technical writing experience is desired
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies: Incumbent must be able to understand cGMP’s requirements. Must have sound problem solving skills and good verbal/ written communication skills. Experience writing technical reports is desired. Must be able to manage and prioritize daily tasks with minimal supervision. Must be capable of using Microsoft Office Word, Excel and PowerPoint. Must be able to learn and navigate through investigation, quality and ERP systems.. Must have independent decision making capability and ability to think conceptually and understand impact of decisions. Expected be hard working and productive in an autonomous environment. Very good conflict resolution and negotiation skills. Good organization skills resulting in the ability to be self-directed and manage multiple projects. Emerging leadership and mentoring skills. Expected to have respectful interactions with individuals with diverse views or backgrounds. Have flexibility to work various shifts times if needed to complete work content.
Able to enter into production areas (PPE required) to support quality investigations
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
FOR HR USE ONLY
Job Code(s): Cincinnati
FLSA Status (US Only): Exempt