Job DescriptionAn amazing opportunity has arisen for a Manufacturing Associate Specialist at our Dundalk site. You will be responsible for providing day-to day operational support to the DS manufacturing teams, including hands-on support during campaigns and troubleshooting production/process issues.Bring energy, knowledge, innovation to carry out the following:Own and coordinate document control activities: create, review, revise and archive SOPs, OJTs, risk assessments, quality statements. Ensure documents are compliant, controlled and accessible. Attend, facilitate Tier and cross-functional meetings. Escalate issues promptly to maintain business continuity. Drive continuous improvement: identify, propose and support implementation of process and documentation improvements to increase quality, reduce risk and accelerate production readiness. Perform all duties in accordance with cGMP, SOPs, and controlled documents.What skills you will need:In order to excel in this role, you will more than likely have:Minimum BSc Degree in Science, Biotechnology.Experience in biopharmaceutical manufacturing. Experience with GMP systems. Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. Able to coordinate cross-functional activities, lead meetings and escalate effectively to maintain business continuity.Excellent document writing, review and technical-communication skills; attention to detail for controlled documents and templatesAn enthusiastic individual who has demonstrated the ability to adapt to daily challenges of a manufacturing work environment while maintaining a positive and productive attitude and fostering this attitude among direct reports. Create, review manufacturing documentation as needed.Required Skills: Accountability, Biopharmaceutical Industry, Biotechnology, Business Administration, Continual Improvement Process, Detail-Oriented, Document Controls, GMP Compliance, Manufacturing, Manufacturing Documentation, Manufacturing Support, Operations Management, Pharmaceutical Microbiology, Production Optimization, Quality ManagementPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:12/15/2025*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.