- Tris Pharma (Monmouth Junction, NJ)
- …position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality ... quality functions and systems including, but not limited to: investigations , deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative… more
- Merck & Co. (Durham, NC)
- …vaccine capital projects Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related) ... of regulatory inspections by presenting and defending technical documentation, investigations , and change controls Evaluate and develop innovative process… more
- Repligen (Waltham, MA)
- …ISO 9001 standard.Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. ... Design History Files for the site. Assists with OOS investigations , OOT investigations and NCMR investigations .Completes required actions for identified… more
- Aequor (Tampa, FL)
- …sampling and testing. Performs microbiology methods and sampling techniques. Performs investigations and completes CAPA in response to laboratory investigations . ... Manages change controls effectively. Manages/ supports microbiology projects from production or formulations development dept. Actively participates in customer and regulatory audits as area SME. Develops and executes validation protocols for test methods and… more
- Aequor (Houston, TX)
- …the Warehouse floor for data gathering and observing of processes for investigations o Performs other duties as assigned. Technical Knowledge Experience performing ... root-cause analysis, leading, and completing lab investigations Prior experience working in a laboratory setting required...floor for data gathering and observing of processes for investigations Willing to pursue opportunities that can lead to… more
- Merck & Co. (Rahway, NJ)
- …facilitates high risk and highly complex Quality-related process reviews and/or investigations .Provides project direction in the area of expertise in own discipline ... matrix management environment).Leads Quality-related reviews, cross-functional process teams, and/or investigations , serving as a subject matter expert.Engages in strategic… more
- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, second generation process development and authoring ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Merck & Co. (Rahway, NJ)
- …process development through process tech transfer, scale-up activities, quality investigations , change management, and authoring GMP standard operating procedures ... aseptic processing, equipment, and sterile technique.Experience in leading quality investigations and change management.Familiarity with United States and European… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issue and handles project. This position prepares trainings, supports CAPA investigations , case review, documentation reviews in collaboration with the ICSR ... basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight: Acts as subject matter… more
- Merck & Co. (Rahway, NJ)
- …regulations and processes.- It is expected that this role will lead significant investigations or events directly, and mentor and coach their team to provide ... on-going support.Essential Duties and Responsibilities:Lead and manage a team of subject matter experts focusing on product control strategies, statistical analysis, and advanced statistical methods, including principal component analysis, etc.Develop and… more
- Eisai, Inc (Raleigh, NC)
- …\tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on ... product quality. \tActing as a Subject Matter Expert (SME) during regulatory inspections in assigned area(s) of responsibility.This role requires a high level of independence, attention to detail, and strong communication skills to foster effective… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes… more
- Secretariat Advisors LLC (San Francisco, CA)
- …on significant litigation matters and bet-the-company disputes and investigations . Specifically, Secretariat specializes in securities litigation, M&A disputes, ... disputes, economic damages, and a variety of forensic accounting investigations . Secretariat's experts maintain integrity, quality, and objectivity when solving… more
- Merck & Co. (Durham, NC)
- …to ensure compliance with Good Manufacturing Practices and safety.Participates in investigations of automation incidents and problems to prevent recurrence including ... the development and implementation of corrective actions.Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems.- Leads in installing and placing new equipment into operations.- Develops… more
- AUROBINDO (Dayton, OH)
- …laboratory instruments/equipments with supervisory direction/training.7. Perform troubleshooting and investigations under the direction of a supervisor.8. Comply ... with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.9. Review of Analytical documents as requiredQualifications - Skills &… more
- Merck & Co. (Durham, NC)
- …and complete SOP revisions.Lead 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review and ... approve out of tolerance (OOT) records and ensure quality notifications follow when required.Facilitate scheduling of calibration activities with the Planning and Scheduling team.Anticipates and interprets client and/or customer needs to identify… more
- Merck & Co. (Durham, NC)
- …SOP revisions.Participate in 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review ... and approve out of tolerance (OOT) records and ensure quality notifications follow when required.Facilitate scheduling of calibration activities with the Planning and Scheduling team.Support training program for calibration technicians.Works as a liaison… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …position carries out routine QC testing and may support sampling, investigations , validations, projects and other related support activities for the manufacturing ... or method verification/validation activities Participates in deviations and laboratory investigations Update standard operating procedures with help Delivers training… more
- AUROBINDO (Durham, NC)
- …employee concerns and workplace issues.Assist in resolving conflicts, conducting investigations , and recommending disciplinary actions when needed.Foster a positive ... and inclusive work environment.HR Policies & ComplianceEnsure company policies are compliant with labor laws and regulations.Communicate and enforce HR policies and procedures.Maintain employee records and documentation in accordance with legal… more
- Merck & Co. (Durham, NC)
- …for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces ... an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups as required.Key Duties:Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including… more
