- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reagents.Strive to reduce non-conformances in supported areas by proactively driving compliance .Support Investigations team by providing quality and ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- vaco (Youngsville, NC)
- …employee inquiries, including onboarding, benefits, FMLA, I-9s, employee relations, and investigations .Ensure HR compliance with both legal requirements and ... key HR metrics (turnover, PT/FT, employment engagement survey analytics, learning/ compliance ) in a merit-driven culture.Self-Starter: Must be highly motivated,… more
- Eisai, Inc (Nutley, NJ)
- …Support investigations by conducting data reviews to identify potential compliance risks or violations Partner with Commercial Operations, IT, and Finance to ... process improvements using technology and AI to streamline monitoring workflows Utilize compliance systems to support audits and investigations Propose and… more
- Merck & Co. (Lower Gwynedd, PA)
- …PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines bioanalytical group located ... and efficacy clinical patient data required for regulatory filings. The compliance team will ensure all operations, documentation, procedures, and filings meet… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance . Additionally, the ... determination.Work cross functionally with SME's and Quality to ensure robustness of investigations , as well as accuracy and ensuring compliance .Support and… more
- Merck & Co. (Lower Gwynedd, PA)
- …Laboratory Documentation, Laboratory Information Management System (LIMS), Laboratory Investigations , Process Improvement Projects, Project Management, Regulatory ... in Lower Gwynedd Township, PA.-As a member of the Late Development Vaccines Compliance team, the successful candidate will oversee the quality and compliance … more
- Merck & Co. (Durham, NC)
- …accordance with OSHA and other regulatory agencies- Identifies and addresses compliance , environmental, safety, and process deviations as required and escalates to ... in at least 1 manufacturing area.Technical writing experience, ie investigations , change requests, standard operating procedures, batch records, protocols.-Must be… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …meet business objectives.Support HR supervisory activities for designated team members.Support Investigations team by providing quality and compliance input for ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
- Monster (Pittsburgh, PA)
- …background: Banking, risk and controls testing, risk mitigation Fraud/Financial Crimes Investigations Regulatory Compliance Banking Process, Risk, and Control ... Fraud RCSAs (Risk Control and Self Assessments), Issues Management, Regulatory Compliance , and SIR/SAR processes. Impact/Function this role has within the bank/LOB:… more
- Monster (Tupelo, MS)
- …new hires Responsible for employee communication, disciplinary meetings, terminations, and investigations Maintains compliance with federal, state, and local ... goals, etc. Develop new HR - Human Resources programs for employees, and manage compliance with labor laws Conduct HR - Human Resources meetings on how to implement… 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
- Monster (Seattle, WA)
- …samples and turn-around of analytical data. * Support production related investigations , ensuring compliance with internal standards and regulatory requirements. ... knowledge of statistical software (R, JMP, Minitab) * Experience executing investigations in support of commercial manufacturing * Experience with commercial product… more
- Tris Pharma (Monmouth Junction, NJ)
- …projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action Preventive Action ... studies to support MV, method transfer and complex technical investigations and assists and trains lower level scientists.Responsibilities:Carries out… more
- Merck & Co. (Rahway, NJ)
- …to pharmaceutical drug substance and drug product development, GMP compliance in commercial manufacturing and data integrity.Responsibilities Include:Lead and/or ... reports, experimental designs, regulatory submission documents, etc.Lead and/or perform investigations with strong technical troubleshooting skills and assist in… more
- Merck & Co. (Rahway, NJ)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide ... community. The COE teams provide support to life cycle changes, investigations , trouble shooting and continuous improvement initiatives to guarantee the robustness… more
- Merck & Co. (Rahway, NJ)
- …expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA ... anticipate, and solve significant scientific and technical challenges.Lead complex investigations into technical challenges related to design, manufacturing, and… more
- Repligen (Waltham, MA)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO 9001 standard.Review… more
- UNC Health (Chapel Hill, NC)
- …health and well-being of the unique communities we serve.Summary:Responsible for assisting Compliance management in all compliance activities which could include ... reviewing internal processes, documents and reports, and ensuring compliance with internal and external regulatory framework. Serves as an expert resource to… more
- Merck & Co. (Rahway, NJ)
- …information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) ... for in-house or outsourced manufacturing for clinical supplies.- Duties include compliance oversite of program-related activities, batch record review and approval,… more
