Senior Specialist - Quality

Job description

Job Description **Senior Specialist- Quality & Compliance** Our Company's Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. Responsible for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance. Partners with change control initiator/owner and various stakeholders in Regulatory, Technology, Supply Chain, Operations, and Quality to coordinate assessment and approval of analytical change controls. Ensures alignment across subject matter experts and stakeholders to implement analytical changes globally. Operates in a complex business environment with significant regulatory complexity. Coordinates resolution of misaligned change control priorities across operating units within and across Small Molecule, Biologics, and Vaccines. Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices (cGMP) expectations. - Ensures that all Analytical Standard documents are written clearly and unambiguous, are maintained in accordance with established divisional and departmental procedures, and issued in a timely fashion. Maintains active ingredient, intermediate, raw material, excipient, component and final product Analytical Standards. - Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices (cGMP) expectations. - Participates in activities and interactions of interest to our Company in regard to the compendia. Provides review of proposed and official compendial publications in CAIT system and collaborates with compendial stakeholders to determine path of implementation for compendial updates. - Proceeds independently on his/her knowledge of change control, carrying full responsibility for the implementation of the appropriate scientific principles, procedures, and divisional guidance's. Escalates issues as appropriate. Imparts creative thinking, the development of original concepts, and resourcefulness for a high level of performance and achievement for the organization. - Ensures appropriate level of support and service is provided to all customers and business stakeholders. Exercises the utmost professional objectivity and integrity in reporting findings and interacting with others. Proficient in recognizing and dealing with conflicting issues, and the ability to build consensus. - Maintains a broad based knowledge of cGMP's, Our Company's Policies, Procedures and Guidelines, regulatory requirements, compendial requirements, etc. pertinent to the manufacturing, personal safety, control, testing and documentation of pharmaceutical products. Maintains awareness of evolving industry and regulatory trends and seeks opportunities to influence direction. - Demonstrates continuous improvement through the ability to optimize functional performance and teamwork through the relentless pursuit and application of standards, best practices, appropriate tools, to positively impact individual and organizational performance, quality, and outcomes for delivery of value and competitive success. - Assists in escalating change control issues through the change control process. Works with our Manufacturing Division network to remove bottlenecks to ensure on time delivery of the change. - Performs appropriate document review and change control quality approval activities associated with their position and ensures change control is in compliance with all regulatory and current Good Manufacturing Practices (cGMP) expectations. **Education Minimum Requirement:** - BS degree required, concentrations in life sciences, engineering or related relevant discipline **Required Experience and Skills:** - Minimum of 10 years applied professional work experience working in one or more of the following areas: Change Control, Laboratory Operations and/or Quality operations with laboratory oversight. - Strong technical knowledge and high level of technical performance - Ability to lead/work well in teams, managing multiple projects/tasks simultaneously with competing priorities - Strong collaborative and communication skills **Preferred Experience and Skills:** - Ability to lead/work well in teams, managing multiple projects/tasks simultaneously with competing priorities - Strong collaborative and communication skills - Superior written and oral communication skills - Advanced problem solving and proficient decision making skills - Proficient computer skills Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. **NOTICE FOR INTERNAL APPLICANTS** In accordance with [Managers' Policy - Job Posting and Employee Placement,](http://webview.merck.com/webview/getContentById/Policy+%28US+%26+PR%29+Job+Posting+and+Employee+Placement.docx?version=Current&format=pdf&DocbaseName=mcdsprd&ObjectId=090157b481ba23f3&cid=090157b481ba23f3) all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered