- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...parameters and provide technical leadership for deviation investigations Analyze data to provide recommendations for improvements in the manufacturing… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and inspections Provides technical support to team, including analyzing and interpreting validation data and making independent tactical decisions based on ... Relocation Assistance is eligible for selected candidate. Relationships Reports to: Manager of Validation & Manufacturing Engineering Number of subordinates… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Laboratory Compliance Manager role is an exempt level position with responsibilities...oversee the reviewing and approving of site SOPs, method validation / qualification/ transfers, and general compliance / quality… more
- Novo Nordisk Inc. (Durham, NC)
- …General experience with regulatory audits/inspections required Knowledge of relevant master data preferred Validation experience preferred Product transfer (or ... make what matters. The Position If you enjoy reading data , analytics, or statistics? This role may be of...that relevant actions are carried out and completed. Relationships Manager . The role is responsible for collaborating with stakeholders… more
- Aequor (Devers, TX)
- …Update, create, and approve all necessary UAT test scripts. DCT Verification and Validation : Approve Site Procurement Data Load Files in support of simulated ... in ensuring the successful migration from Oracle to SAP, focusing on procurement data and processes. The ideal candidate will have extensive knowledge of SAP,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the unitized budget against the needs, conducts rigorous negotiation of terms with validation of rates from service providers. Making sure the payment schedules are ... colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …an onsite role Monday-Friday. Relationships Reports to: Manufacturing Engineering & Validation Manager Number of subordinates with direct/indirect referral: none ... archiving. Documents are role-specific but could be drawings, vendor data , turnover packages, commissioning documents, validations, engineering test plans, SOPs,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Engineer will participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous improvement efforts following ... Scrap, number of repeat CAPAs, CAPA On Time, and Validation on Time.Job ResponsibilitiesChange Management - evaluate the impact...done in a disciplined manner to document decisions and rationale. Data Integrity - ensure GMP data captured… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for reviewing and approving, of standard operating procedures (SOPs), validation / qualification/ method transfer protocols, completed assay data and ... products.Review and approval of standard operating procedures.Review and approve Validation /Qualification/Method Transfer protocols, completed Assay Data and… more
- Novo Nordisk Inc. (Durham, NC)
- …Senior Manager . Essential Functions Provide statistical support and probability data as it relates to design and analysis of experiments, setting of ... Cycle Management Department. This role will provide statistical support and probability data to the site through collaboration with cross-functional teams and global… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for architecting and coordinating the design, installation, commissioning, startup and validation of all assigned new capital improvement projects. Primary the ... System (BMS) and Environmental Monitoring System (EMS). Relationships Reports to: Manager of Automation Engineering Essential Functions Lead, plan, organize and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …will be commisserate with experience. Relationships Reports to: Automation Manager Essential Functions Responsible for assisting with the design, implementation, ... power systems throughout the facility Assists with troubleshooting, testing, validation , deployment and on-going maintenance of Automation Systems Provides support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and specify process-specific equipment and performs analysis to justify investmentsGather data and trend results of overall quality and efficacy of equipment ... manufacturing equipment in accordance with site Change Control and Validation requirementsPerform investigation of manufacturing eventsPerform process & engineering… more
- Merck & Co. (Durham, NC)
- …to meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review and review of ... environmental monitoring data . Perform review of process simulation batch records. Perform...team with executing and approving change controls. Approve cleaning validation documentation as needed. May act as a Quality… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by Manager , Quality Assurance Review and assess Corrective and Preventive Actions Reviews and ... approves validation documentation Reviews and assesses deviations; includes tracking, follow-up...Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors. KEY Excellent written… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports… more
- Merck & Co. (Durham, NC)
- …and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support ... to include active air and surface sampling and water samplingEvaluates data , conducts trouble shooting, process improvements, report writing, involvement in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development ... CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main… more
- American Heart Association (Dallas, TX)
- …make with us. The American Heart Association has an excellent opportunity for a ** Data Validation Program Manager ** supporting our National Center office ... that is located in Dallas, TX. This role can be home based. The ** Data Validation Program Manager or** **Compliance Audit and Program Manager ** ensures… more
- Carnival Cruise Line (Miami, FL)
- The Manager , Data Validation is responsible for the design and delivery of the MAST data validation process for all brands within the Carnival ... phase of the MAST Program + Oversee the end-to-end data validation process for core, reference and...+ Vacation Time - All full-time employees at the manager and below level start with 14 days/year; director… more
