Quality Operations Specialist

Quality-On-The-Floor SpecialistWith the support of over 800 talented employees, Thermo Fisher Scientific's Oral Solid Dose (OSD) site in Cincinnati, Ohio provides comprehensive drug development and commercial manufacturing services. The site specializes in advanced dosage forms including controlled and sustained release products, osmotic release dosage forms (laser drilling), liquid-filled hard capsules, controlled substances, and abuse-deterrent technologies.As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure the highest quality standards across our operations, supporting our Mission to enable our customers to make the world healthier, cleaner, and safer. As a Quality-on-the-Floor Specialist, you will collaborate cross-functionally to strengthen quality systems, drive continuous improvement, and ensure regulatory compliance in a highly regulated pharmaceutical manufacturing environment.Shift: FOWN (Front of Week Nights) Monday-Wednesday 6:00pm-6:30amWhile on training for 1-3 months schedule will be Monday-Friday 8AM-5PMA Day in the LifeServe as Senior QA point of contact for Quality RAPID events, facilitating path-forward and disposition determination, immediate containment actions, and ensuring sufficient data is collected to support complete and accurate deviation report generation at the conclusion of the RAPID.Author clear, thorough, and scientifically sound deviation reports.Partner with QA Management, Operations, Technical Services, Engineering, and other SMEs to ensure investigation conclusions are robust, well-supported, and aligned with GMP expectations.Collaborate with Client QA to review deviation report feedback, resolve comments, and ensure final reports meet site, client, and regulatory expectations.Track deviation report progress through review, comment resolution, approval, and closure, proactively escalating barriers, overdue actions, or alignment concerns to support timely and compliant investigation completion.Perform in-process QA checks prior to batch initiation for each manufacturing sub-phase, cleaning & swab verification, equipment functionality, operator training, and GMP documentation checks, ensuring errors are resolved before production start and coaching Operations personnel along the way.Support Change Control activities by creating, reviewing, and/or managing required batch record insert-pages in accordance with approved procedures.Perform manufacturing barrier checks including installation and removal verification.Support hold tag creation and removal activities (on raw material, product, room, or equipment) and perform associated SAP status changes to ensure accurate product and material control.Provide consultation and guidance for process comments to ensure quality impact is appropriately assessed and documented.Serve as QA representative for Quality RAPID events, supporting path-forward/disposition determination, immediate containment, and ensuring all quality considerations are appropriately addressed.Perform Fit & Finish audits of Manufacturing on an annual basis per FDA requirement to ensure all GMP rooms are inspected and observations are tracked and actioned by support groups.Maintain a safe working environment and report potential hazards.Perform alternating or rotating shift work (as required).Keys to SuccessEducation•High School Diploma or GED with 5 years of experience in a Quality role within a GMP-regulated facility.•Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or a related field with 2 years of experience in a Quality role within a GMP-regulated facility.•Experience in pharmaceutical manufacturing, biologics, medical device, or other regulated manufacturing environments preferred.ExperienceExperience in quality assurance or operations within GMP environment (pharmaceutical, biotech, or medical device preferred)Experience with batch record review preferred.Familiarity with SAP or other ERP systems preferred.Knowledge, Skills, and AbilitiesKnowledgeStrong working knowledge of cGMP, GDP, and FDA/EMA regulatory expectations.Understanding of pharmaceutical manufacturing processes and cleanroom operations.Familiarity with batch record documentation and data integrity principles.SkillsStrong attention to detail and documentation accuracyEffective communication and on-the-floor coaching abilityAbility to identify compliance gaps and drive immediate corrective actionsOrganizational and time-management skillsStrong verbal and written communication skillsStrong interpersonal skills with the ability to collaborate across functions and levelsAbilitiesProblem-solving and root cause analysis capabilitiesAbility to make sound quality decisions in real timeAbility to work effectively in controlled manufacturing environmentsAbility to balance compliance requirements with operational efficiencyAbility to collaborate cross-functionally and escalate issues appropriatelyAbility to work independently to consistently meet daily and weekly expectationsPhysical Requirements / Work EnvironmentWorkstation is located in pharmaceutical manufacturing environmentAbility to stand and walk for 10 hours or more per dayAbility to wear appropriate personal protective equipment (PPE) as required