- Merck & Co. (Durham, NC)
- …shift P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all Quality related functions that directly support Durham ... and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is responsible/accountable for Quality Assurance activities that support VMF,… more
- Merck & Co. (North Wales, PA)
- …purchasing controls and supplier quality.Work with external partners to develop products. Review and approve verification/ validation test protocols and reports to ... Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders such as MR team, MR vendor and AOR (strategy validation &- pull through-tactics) Synthesize information from market research outputs to develop ... in Oncology or Hospital/SpecialtyExperience in company end-to-end medical/legal (Promotional Review Team) review and delivery processes.Experience with… more
- Catalent (San Diego, CA)
- …production of samples and approve the respective specification of raw materials. Review calibration, validation and preventative maintenance certificates of ... Job Title: Quality Assurance Associate , Analytical City: San Diego State : CA..., Analytical City: San Diego State : CA JOB DESCRIPTION: Review of analytical release and stability data, involving … more
- Merck & Co. (Rahway, NJ)
- …the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, ... product lifecycle.Primary Responsibilities:Effective analysis and report programming development and validation utilizing global and therapeutic areas standards and following… more
- Insmed Incorporated (Bridgewater, NJ)
- …transfer, process optimization, clinical/commercial manufacturing, process characterization and validation , and manufacturing CMC development strategy. Remote (only ... process.Responsible for technical support as Insmed's internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets,… more
- Merck & Co. (Durham, NC)
- …facility. As a direct report to the Director of Operations, the Associate Director will be accountable for the following: Support a comprehensive technology ... process improvements initiatives related to compliance, efficiency, and cost. Author, review , and/or edit operating procedures and training documents to support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs to AI/ML tasks, over data understanding and preparation, to modeling, validation and dissemination- Identify innovative ways to improve the efficiency, quality ... guidelines- Engages, under supervision, in vendor selection and contracting, including review and negotiation of baseline budget and timelines- Oversees budget… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …established standard processes to facilitate alignment of technology transfer and validation activities across the projects for (mAb, Drug Substance, Drug Product, ... the main interface to internal and external manufacturing sites. Review technical documentation (protocols, reports) associated with manufacturing, technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review , SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review . Acts as ... complex study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation,… more
- Merck & Co. (Rahway, NJ)
- …drug products through Phase 3 clinical development and line of sight to process validation and commercial launch.- This role reports into the Associate Vice ... tools, and biopharmaceutics principles that satisfies stage 1 and stage 2 validation criteria and follows QbD principlesOversee formulation and process scale up from… more
- Merck & Co. (Durham, NC)
- …and other project objectives.Provide technical guidance/support including authoring or review and approval of system commissioning and qualification documents, ... processesProviding direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expertUnderstands and… more
- Eisai, Inc (Nutley, NJ)
- …Nutley, NJ.Support clinical applications for clinical data management. Perform data review and data cleaning in Oncology clinical area. Develop dashboard, standard ... data transfers eg, laboratory data, PK, ECG,Tumor. Participate in system validation , customization, and integration of new tools and technologies. Requires:… more
- Merck & Co. (Durham, NC)
- …and maintenance of equipment/utility systems.Assist with execution of calibration, automation, validation and additional testing, as requiredWork within a team to ... safety, GMP, and calibration/maintenance procedures.Facilitates contractors by obtaining bids, review contracts, supervises work execution, and follows-up on contract… more
- S&P Global (New York, NY)
- **About the Role:** **Grade Level (for internal use):** 11 **The Role** Associate , Review & Validation **Grade (relevant for internal applicants only)** 11 ... **Location** Primary: London/New York Secondary: Chicago. **Team** The Review & Validation team has global responsibility for the review and validation … more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Validation department at Regeneron is adding to their team! The ** Associate ** **QA Validation Specialist - External Partners** coordinates the equipment, ... standards policies and procedures. The External Partners team supports validation discussions, documentation creation/ review /approval, assess investigations and… more
- Santander US (Dallas, TX)
- Associate , Business Control & Risk Management (IT Process Validation ) Dallas, United States of America **Job Profile Summary** The Associate , Business ... line execution against the Enterprise Risk Management Framework. Specifically, the Associate works to identify, assess key risks and control effectiveness throughout… more
- Catalent Pharma Solutions (Bloomington, IN)
- …for qualification reports; complete and review calculations and perform technical review of validation documents + Lead investigations, change controls, and ... **Senior Validation Engineer - Cleaning** Catalent is a global,...with other departments and with clients to ensure accurate review of documentation and serves as the point of… more
- Catalent Pharma Solutions (Bloomington, IN)
- …approving documentation, evaluate and determine required validation testing, and validation services including contract review and approval, and overseeing ... + Review change controls for process impact + Supervises Validation personnel with oversight from management, including assignments and priorities, providing… more
- Crown Equipment Corporation (New Bremen, OH)
- Embedded Software Test and Validation Engineer (Indefinite US Work Authorization Required) Location: New Bremen, OH, US, 45869 **Company Description:** Crown ... Responsibilities:** Work with product developers on the design qualification and validation of electronic, hydraulic, and mechanical systems over a wide spectrum… more
