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 followingOwn 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 NeedIn order to excel in this role, you will more than likely haveMinimum 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 SkillsAccountability, 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 SkillsCurrent Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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 StatusRegularRelocationVISA SponsorshipTravel RequirementsFlexible Work ArrangementsNot ApplicableShiftValid Driving LicenseHazardous Material(s)Job Posting End Date12/15/2025A job posting is effective until PM 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 IDR373142