Employment Type : Full-Time
Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Position Overview – Basic Functions & Responsibility The Quality Specialist provides direct Quality assistance to a production area as part of a Quality IPT (Integrated Product Team) operating model. The Quality Specialist, with guidance from the Quality Manager or IPT Quality Lead, ensures product/process quality, represents Quality on the shop floor, and performs activities to facilitate the release of product to the marketplace. The Quality Specialist will work closely with IPT in a team environment to ensure timely review of documentation is Right First Time (RFT). The incumbent will: provide assistance to the production floor when needed, ensure adherence to cGMPs, complete batch disposition activities for release of product, and assist with investigation of deviations. Additionally, the Quality Specialist, collaborates with Operations, Laboratory Operations, Technology, and Planning to enable RFT production, learn the manufacturing process, and ensure compliance with cGMPs and regulatory requirements. Education: Qualifications and Skills: - Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.- Demonstrated interpersonal skills including flexibility, partnership and inclusion skills and ability to work in a team environment Preferred Qualifications and Skills: Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. Who we are … We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for … In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth. INVENT. IMPACT. INSPIRE. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, 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 a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. US and Puerto Rico Residents Only: If you need an accommodation for the application process please email us at staffingaadar@msd.com