Job Description Are you interested in Quality Assurance and eager to contribute to the development of life-saving treatments? We have an exciting opportunity for you to work in our Quality Assurance Team supporting our site during compliance inspections, including internal and corporate audits as well as Regulatory Inspections. Responsibilities Ensure that all batch related records are reviewed and approved in a timely manner for completeness, accuracy and adherence to Good Documentation Practices (GDP) Conduct final review of Seed folders and convey Seeds status to relevant departments Communicating with departments with regards to documentation status; maintaining the document management system (MEDS) by assisting with the review and approval stages Responsible for the implementation, execution and ownership of Quality Systems, including electronic document management, change control and Deviation/CAPA Management Implementation of global and site quality procedures Supporting cross-functional departments to assess change control impact and ensuring their timely review, implementation and closure Raising non-conformities, technical incidents and taking suitable and appropriate corrective actions Participate in RCA investigations, developing robust CAPA’s or change controls to rectify the problem and prevent recurrence Mentor and coach stakeholders in cGMP practices to maintain and develop a cGMP environment Perform internal audits Maintain and promote a state of audit readiness Qualifications/Skills Experience of working in a cGMP environment and working within a Quality Management System Proven industry experience in Quality Assurance within the Pharmaceutical industry; experience with production of a Pharmaceutical product would be desirable A working knowledge and practical experience with the regulatory requirements for manufacture of licensed medicinal products Internal Audit Experience desirable Good communication skills We could look at part time hours for the right candidate. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation No relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Not Applicable Shift Valid Driving License Hazardous Material(s) Job Posting End Date 11/8/2024 A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID R312911