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Senior Specialist, Quality System Improvement Program Job Durham United States,  


Posted on : 15 May 2017

Project Description

Senior Specialist, Quality System Improvement Program-QUA005848DescriptionMerck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.GENERAL SUMMARY:The Senior Specialist, Quality QSIP is responsible/accountable for Quality activities, including execution of Quality System Improvement Program Deployment, which include but are not limited to the following activities:Assist the site QSIP Lead in project management, including maintenance of the deployment schedule, managing Quality Management System Gap Assessment Team Site and maintenance of completed QMS Gap Assessments in MIDAS.Assist System and Sub-System owners with the following: gap assessment management, Identifying SOPs and personnel impacted by the revised processes, design and implementation of interim controls as needed until closure of gaps is complete, revise SOPs to reflect requirements of the new standard, Conduct organizational assessments, Design training programs, Implement SOPs as they are developed, Establish metrics to monitor system performance, and Issue written confirmation that the system is in use. Assist with all other applicable Quality functions.GENERAL PROFILE: " Requires expertise in own discipline " Applies knowledge of internal/external business challenges to improve products, processes or services " Solves complex problems; takes a new perspective using existing solutions " Works independently, receives minimal guidance " Acts as a resource for colleagues with less experience within own discipline " May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides othersBUSINESS EXPERTISE: " Applies knowledge of internal/external business challenges to provide input into recommendations for improvements to products, processes or services " Understands and applies regulatory / compliance requirements relative to their roleFUNCTIONAL EXPERTISE:The Senior Specialist role will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following: " Executes the Project Plan for QSIP " Assists in maintenance of QSIP Deployment schedule " Maintain project plan updates " Managing status of QMS gap assessments on QMS Gap Assessment Team Site " Tracks and monitors maintenance of completed QMS Gap Assessments in MIDAS " Initiate any Change Controls in the GCM TrackWise system that are required for QSIP Deployment " Assist System and Sub-System owners with gap assessment management, Identifying SOPs and personnel impacted by the revised processes, design and implementation of interim controls as needed until closure of gaps is complete. " Assist System and Sub-System owners in revision of SOPs to reflect requirements of the new standard, and conducting organizational assessments. " Assist System and Sub-System owners in design of training programs, assignment of training to the required personnel and implementation of SOPs as they are developed, " Assist System and Sub-System owners in establishing metrics to monitor system performance and issue written confirmation that the system is in use. " Assists the Associate Director, QSIP Site Lead in coordination of Regulatory Inspection and Divisional audit activity. " Tracks and monitors timely completion of all commitments and maintains an evidence file for completed items. " Provides training and guidance to members of the department " Manages internal compliance systems to at least include Quality Council and Site Compliance Work Plan. " Leads project teams ensuring delivery of results against established timelines. " Manages Quality Risk Management System and Enhancements, per Divisional guidanceOther: " Reviews and approves SOPs for Operations and supporting departments. " Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of Vaccine & Sterile Operations  business processes. " Other duties as requested by management.PROBLEM SOLVING: " Solves complex problems; takes a new perspective on existing solutionsINTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS: " Interprets client and/or customer needs, assesses requirements and identifies solutions to non-standard requestsIMPACT:Influence and Decision Making: " Explains difficult issues and works to build alignment around a complex situation " Makes decisions within guidelines and policies which impact a range of standard and non-standard client, customer, operational, project or service activitiesPROJECT MANAGEMENT: " Lead projects as required based upon business needsRESOURCE MANAGEMENT: " Aware of costs and assists in controlling costs related to own workPHYSICAL REQUIREMENTS: " Ability to gown aseptically " Ability to travel (estimated 25%)WORKING RELATIONSHIPS:Reports to Associate Director, QSIP Site LeadInteracts with employees within own departmentFrequent interaction with employees from other departmentsInteracts with representatives from regulatory agenciesNote: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.QualificationsEducation MinimumRequirement:- A minimum of a Bachelor sdegree (or equivalent degree)Required Experience andSkills:- Minimum 5 years experience in pharmaceutical operations, technical services, and/or qualityoperations with at least 4 years in a quality function- Experience leading a qualitysystems implementation project- Knowledge of GMPregulations specific to the pharmaceutical industry- Experience authoringStandard Operating Procedures (SOPs)- Experience developing trainingcurriculaPreferred Experience andSkills:- Experience leading organizational change management- Lean Six Sigma certificationsor training- A degree focused in Scienceor Engineering- A Master s degree orother advanced degreeOur employees are thekey to our company s success. We demonstrate our commitment to our employeesby offering a competitive and valuable rewards program. Our Company sbenefits are designed to support the wide range of goals, needs and lifestylesof our employees, and many of the people that matter the most in their lives.If you need an accommodation for the application process please email usat staffingaadar@merck.com.Search FirmRepresentatives Please Read Carefully:Merck & Co., Inc. isnot accepting unsolicited assistance from search firms for this employmentopportunity. Please, no phone calls or emails. All resumessubmitted by search firms to any employee at Merck via email, the Internet orin any form and/or method without a valid written search agreement in place forthis position will be deemed the sole property of Merck. No fee will bepaid in the event the candidate is hired by Merck as a result of the referralor through other means.Visa sponsorship is notavailable for this position.For more informationabout personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Quality OperationsJob Title:Sr. Spclst, QualityPrimary Location: NA-US-NC-DurhamEmployee Status: RegularTravel: Yes, 25 % of the TimeNumber of Openings: 1Shift (if applicable): 1stCompany Trade Name:Merck Nearest Major Market: Durham Nearest Secondary Market: Raleigh Job Segment: Law, Pharmaceutical, Engineer, Lean Six Sigma, Compliance, Legal, Science, Engineering, Management

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Durham, NC, US

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