Release Coordinator (local sites in US and Europe) Job Job in West Point, Pennsylvania US
Release Coordinator (local sites in US and Europe) Job
Release Coordinator (local sites in US and Europe)-QUA002834 Description Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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 people 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. Position Overview Responsible for implementing Quality Operations (Quality Assurance and Quality Control) policy and for discharging QO responsibilities supporting external manufacturers of sterile pharmaceuticals, vaccines and biologics. These activities include involvement in most aspects of external manufacturer operations related to the quality of products produced. Responsibilities are as follows: * Release of all manufactured products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies. * Exercises a leadership role in monitoring and maintaining the External Manufacturer's compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements. * Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external manufacturers of sterile pharmaceuticals. * Receive guidance on policy issues as well as general and specific direction with regards to operations from the Director Quality Operations - External Manufacturing QA. * Assure compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign. * Support the development and maintenance of a Quality Agreement with the external manufacturers. May provide input into the development of contractual agreements with the external manufacturers. * Review all audit outcomes pertaining to the sterile pharmaceuticals, API intermediates, API, non-sterile pharmaceuticals, and biologics external manufacturers and ensures appropriate and timely corrective actions were warranted. * Act in conjunction with the Director Quality Operations - External Manufacturing QA as the Merck Quality Operations point of contact to the external manufacturers. Responsible for coordination, oversight, and communication on matters related to the GMP status of the external manufacturer. Must be conversant with all regulations and compendia (domestic and foreign) governing the external manufacturer's operations. * Act as a liaison of contact between external manufacturer and internal Merck site personnel. * Contribute to and carries out a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the external manufacturer. * Involvement of the releasing of all products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations. Before shipment, he/she will assure that products manufactured by the EM have the correct quality and identity, meet all pertinent specifications and special requirements, and have been produced by approved processes and under proper conditions. * Track and monitor operational and quality performance. * Release of all purchased materials with assurance to plant management that all quality specifications are met. Monitors efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forums. * In conjunction with other internal Merck departments (RAS, GPC), ensures that external manufacturers are inspection ready for all new product introductions or transfers. * May act as a regulatory compliance liaison on Merck's behalf to interface with regulatory Agencies. * Assist in the coordination of significant investigations including Fact Findings. Assists in the coordination of any product recall involving the external manufacturer. Please note that this position can be located in US or Europe at the Merck local sites. There is no international relocation offered. Local candidates are considered. The sites are as follows: Local sites in US: Whitehouse Station, NJ, Summit, NJ, West Point, PA, Wilson, NC, Barceloneta, PR Local sites in Europe/Asia: * China: Hangzhou * India: Hyderbrad * Switzerland: Lucerne or Sion * Spain: Madrid * Brazil: Sao Paolo or Buenos Aires * Ireland: Brinny Qualifications Education: * BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or related area. Required: * Minimum of 6 years relevant experience * Strong knowledge of and broad experience in product Quality Assurance and Quality Control activities. * Strong demonstrated interpersonal, communication, negotiation, and persuasion skills. * Strong relationship building skills. * Conversant with all domestic and foreign regulations compendia governing External Manufacturing operations. * Some level of contractual and financial awareness. Preferred: * Aseptic/sterile product knowledge, including liquid, lyophilized, and biologic products. Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. merck.com/careers to create a profile and your resume for requisition QUA002834. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully: Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Primary Location: US-PA-West Point Other Locations: IN-AP-Hyderabad, Puerto Rico, BRZ-S o Paulo, US-NJ-Whitehouse Station, IE-Munster-Brinny, US-NJ-Summit, ES-M-Madrid, US-NC-Wilson, CH-Lucerne Employee Status: Regular Number of Openings: 2 Shift (if applicable) : 1st *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Merck prefers that you apply to this job directly on their site