- Tris Pharma (Monmouth Junction, NJ)
- …position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Merck & Co. (Durham, NC)
- …leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our ... calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by through analysis… more
- Merck & Co. (Durham, NC)
- …calibration program, including implementation of new instruments for calibration, investigation into instrument events and continuous improvement by thorough ... SOP revisions.Participate in 8-step problem solving sessions to support investigations and develop appropriate CAPAs which lead to program improvements.Review… more
- Eisai, Inc (Raleigh, NC)
- …The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This ... \tReviewing and making disposition decisions for manufactured product batches. \tSupporting investigations and evaluating the impact of deviations or events on… 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)
- …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
- Twist BioScience (South San Francisco, CA)
- …the implementation of preventative actions identified through inspections or incident investigations .Assisting in the investigation of EH&S incidents, gathering ... waste management services provided by external vendors to ensure compliance and efficiency.Assist with maintenance of programs and other documentation… 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
- Merck & Co. (Durham, NC)
- … compliance with Good Manufacturing Practices and safety.Participates in investigations of automation incidents and problems to prevent recurrence including the ... of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support,… more
- Merck & Co. (Rahway, NJ)
- …Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations , Confidentiality, Cross-Cultural ... the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating… more
- Merck & Co. (Durham, NC)
- …for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces ... address local business, service and operational challengesQuality & Safety Compliance :Develop and execute engineering change request (ECRs), as necessary.The… more
- AUROBINDO (Durham, NC)
- …training, on-boarding, orientation, policy implementation, compensation, and employment law compliance .Manage and conduct the new hire orientation and exit interview ... employee concerns and workplace issues.Assist in resolving conflicts, conducting investigations , and recommending disciplinary actions when needed.Foster a positive… 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 ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards.Engage Across ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Durham, NC)
- …for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces ... address local business, service and operational challengesQuality & Safety Compliance :Develop and execute engineering change request (ECRs), as necessary.The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …gaps in training requirements for OperationsSupports evaluation of appropriate compliance courses for OperationsPerforms training for new hiresOptimizes the ... efficiency of training program in delivery of qualified personnelSupports investigations and evaluates improvement opportunities for effective compliant training… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out ... routine QC testing and may support sampling, investigations , validations, projects and other related support activities for the manufacturing facility and process.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to ... business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to all applicable codes and regulations as required. Obtains… more
- Merck & Co. (Durham, NC)
- …establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director, ... Resolution (with appropriate escalation as required). Resolve Technical Issues ( Investigations , CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment… more
