QA Change Control Specialist II

Nature and Scope This position is a member of the Change Control Group and is responsible for implementation of processes and/or changes related to the manufacture of safe, pure, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Change Control Group provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. The QA Change Control Specialist will participate in all aspects of the Change Control Process. This includes all elements of the change lifecycle such as initiation, assisting all participants, and hand-offs to implementation as per applicable Standard Operating Procedures. The level II position requires an individual to perform tasks autonomously with anticipated lead roles for the detailed responsibilities below. There is minimal direct supervision. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. - Responsible for the review and approval of change controls, as designee, related to new processes, equipment, material, supplier changes in addition to revisions of documents and creation of new documents. - Assessing the adequacy of submitted change controls. - Independently coordinate with requesting departments to obtain supporting information, resolve change control issues, and facilitate the review/approval/implementation of changes. - Assist users with the electronic document management system for the site. Tasks include training new personnel on the use of the system, and coordinating with GxP and service provider to resolve system issues. - Assessing document drafts for format and content in relation to stated change(s). - Preparing monthly departmental metrics related to change control and document control processes. - Preparing product specific change control reviews for Annual Product Review assessments. - Ensuring the appropriate versions of documents are readily accessible in electronic and/or hard copy form. - Develop, maintain, and facilitate applicable training around the Change Control process and functions. Support preparation of controlled documents through the change control process including proofreading, tracking, and management through completion. - Collaborate and interact with functional areas within the business (Operations, Quality Control, Research & Development etc.). - Work independently and is able to recognize daily needs with minimal supervision while delivering timely results. - Effectively manage multiple tasks while working under pressure. - Providing support for regulatory inspections including tracking inspection requests, retrieving and copying requested documents, and contacting subject matter experts as needed. - Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures. - Able to independently problem solve, provide investigation support, and support the change management function. - Able to develop and revise Standard Operating Procedures related to the Change Control process. - Establish and maintain quality metrics related to the Change Control process. - Take ownership of continuous improvement initiatives to improve the Change Control process. - Able to provide post-implementation support to all stakeholders and Document Control group. - Perform any other tasks/duties as assigned by management. - We all must embrace the QUALITY culture. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/o