- Cipla (Central Islip, NY)
- …PM (May vary based on business needs) Responsibilities/ Accountabilities Lead of investigation team and involve in conducting thorough investigations related to ... Job Title QMS Lead - Investigations Organization Name InvaGen Pharmaceuticals, Inc. Location Central...to identify root causes. Prepare, review and approve detailed investigation reports, including root cause analysis and corrective actions.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports in Trackwise.Review/complete routine CAR-T manufacturing nonconformance/deviation investigations .Proactively work with stakeholders to implement effective ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QC Investigations Specialist II as part of the Quality team based in Raritan, NJ.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over...sterile GMP environment. This includes supporting and approving manufacturing investigations , ownership of various department projects, and tracking of… more
- AUROBINDO (Durham, NC)
- …necessary by the Head of QA. Responsibilities1. Deviation & Investigation ManagementLead investigations for deviations, out-of-specification (OOS) results, ... Quality Employee the QA Investigator will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as… more
- Cipla (Hauppauge, NY)
- …Shift/ Remote 9:00am -5:30pm OT as required Responsibilities/ Accountabilities Investigation of manufacturing and packaging deviations and non-conformances to ... Analysis to determine the likely root cause of the event. Preparing investigation reports that include recommendations on investigation findings for medium/high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as investigation of security breaches Supports supply chain security investigations and planning Leads guard force contract management including KPI enforcement ... personal protection services, perimeter defenses, supply chain security, general investigations , security related compliance issues, physical and logical access… more
- Merck & Co. (Rahway, NJ)
- …lead and support facility operations, process development activities, compliance investigations /change management, authoring of GMP documentation, and lead other ... GMP activities and deliver training as needed. Support deviation investigations , corrective/preventative action closures, and building initiatives as appropriate.… more
- Aequor (Irvine, CA)
- …stakeholders to achieve company objectives, leading technical root cause investigations , developing and executing risk-based decisions, resolving and documenting ... customer complaint and manufacturing investigations , and representing Quality in cross-functional projects. Job Duties: Develops and executes plans for quality and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implementing microbiology procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects.Key ... environmental/utility, and product release testing.Scheduling of daily activities for personnel. Investigation of laboratory non-conformances (events, deviations, and invalid assays).Maintenance,… more
- Cipla (Central Islip, NY)
- …reports and any other study reports. Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same. Verifying the laboratory ... areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance. Performing other departmental and… more
- Cipla (Fall River, MA)
- …Review and approval of manufacturing/engineering change control, deviation investigation and CAPAs. Review and approval of manufacturing/engineering validation ... ability to work in a team environment. Capable of conducting troubleshooting, investigations and root cause identification and analysis. Capable of handling and… more
- Cipla (Hauppauge, NY)
- …site audits to respond to validation-related questions. Assist in deviation investigation and resolution of problems and oversee change control requirements for ... ability to work in a team environment. Capable of conducting troubleshooting, investigations and root cause identification and analysis. Capable of supporting and… more
- Cipla (Central Islip, NY)
- …8:30a - 5:00p Salary Range: $72K - $93K Job Responsibilities Coordinate investigations for LOE and PQCs received regarding InvaGen manufactured products and Third ... party manufactured/Packaged. Reviews the investigation reports submitted by other departments and third-party and writes the summary report to be included in the… more
- Insmed Incorporated (NJ)
- …oversight for laboratory operations, including routine testing, data review, investigations , and documentation. The individual will work collaboratively with ... APSD, MMAD, delivered dose, particle size distribution).Lead and approve deviation investigations , OOS, and OOT results generated by external labs. Ensure thorough… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing record which will involve binding and archiving and storage.Support Investigations team by providing quality and compliance input for continuous ... improvement and remediations; also, support or facilitate investigations for Product Quality Complaints.Review, revise, or draft Standard Operating Procedures (SOPs)… more
- Cipla (Reid, WI)
- …implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends and formal deviations. Develop, implement ... related CAPA's. Hands-on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …data analytics (including CPV), quality compliance (including change control and investigations ), and material/ raw material sub-teams to support global best ... and approving technical documents.Experience with Quality systems (Change control, investigations , LIMs, etc.).Extensive technical writing experience.Knowledge in cell therapy… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support day to day issues in manufacturing such as: deviation investigations , CAPAs, equipment troubleshooting, small scale process development, SOP review, ... determine the root cause and corrective actions for problems associated with investigations Write and review protocols, summary and trend reports and other… more
- Merck & Co. (Rahway, NJ)
- …community. The COE teams provide support to life cycle changes, investigations , trouble shooting and continuous improvement initiatives to guarantee the robustness ... to the portfolio.- This includes above site support for significant investigations , developing new solutions, establishing guidance and standard work. and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by resolving complex and sensitive Employee Relations related issues Conducts investigations into workplace issues, ensuring fairness and compliance with company ... Employee Relations experience preferred including experience that involved conducting investigations Practical experience in employee relations, HR management, or… more
