- Integrated Resources, Inc (Warren, NJ)
- Job Title: Validation Specialist Job Location: Warren, NJ Job Duration: 5 Months Work Schedule: Mon - Fri, Business Hours Job Description: The Validation ... Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include:… more
- Aequor (Swiftwater, MN)
- THIS IS A CLEANING VALIDATION POSITION. Duties Experience in cleaning validation in the biologics or vaccine industry to include the following: o Experience in ... authoring, reviewing, executing and approving validation documents. o Interface with Quality organization and the...Quality organization and the ability to defend rationale in validation documents. o Ability to develop cleaning cycle and… more
- Novo Nordisk Inc. (Durham, NC)
- …help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed ... all deliverables. Relationships Manager. Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC… more
- Sunrise Systems Inc (Summit, NJ)
- …of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/ Validation . Ability to work extended hours or a modified work schedule to assist ... with the ALCOA+ principles of data integrity, risk-based approaches to validation , Computer Software Assurance (CSA) principles Understanding the concept of Critical… more
- On-Board Companies (Bothell, WA)
- …PURPOSE AND SCOPE OF POSITION (Position Summary):The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration ... and validation in the Emerson Syncade Manufacturing Execution System (MES)....system will be considered.* Experience with writing and executing validation protocols.* Strong technical writing competency and GMP procedure… more
- Merck & Co. (Durham, NC)
- …within the Durham manufacturing site. Specifically, you will be responsible for providing validation support in the production of current and new vaccines in the ... Global Vaccine and Sterile Manufacturing organization.The successful Specialist candidate will be energetic and technically sound, with strong interpersonal,… more
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for the BCG vaccine.The Associate Specialist participates in a team of analysts in the development, ... validation , and routine testing for the BCG Product. The...and GMP laboratory readiness.- The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of product… more
- Merck & Co. (Durham, NC)
- …seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities.Invent-- Pursue the ... support laboratory testing for vaccines.The Quality Control Laboratory Associate Specialist participates on a team of analysts in the...on a team of analysts in the method transfer, validation , and routine testing of the vaccine product. Initially… more
- Merck & Co. (Rahway, NJ)
- …community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for the ... Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.Develop and maintain a… more
- Merck & Co. (Rahway, NJ)
- …supply manufacturing facility in Rahway, New Jersey.The Process Engineer role at the Associate Specialist level will serve as a leader in the FLEx Oral Solid Dosage ... Oral Solid Dosage GMP facility.Experience with Commissioning, Qualification and Validation .NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job… more
- Novo Nordisk Inc. (Durham, NC)
- …of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Performs archiving ... - components/raw material, batch records, change control requests, deviations & validation documents Performs QA presence & process confirmation on shop floor… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Specialist is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing ... DeltaV or PLCs (ladder logic, HMIs, or SCADA) required.Computer validation and systems life-cycle development methodology experience required.Preferred Experience… more
- Eisai, Inc (NJ)
- …of the PSSS, including MedDRA coding. This may include participating in the validation process for the PSSS. 70%Ensure accurate and timely submissions to regulators, ... Salary Transparency Language:The base salary range for the Product Safety Specialist is from :85,000-111,500Under current guidelines, this position is eligible to… more
- Aequor (Seattle, WA)
- …cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client ... Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation , etc.). Must complete tasks independently, notify manager of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The ... QA Warehouse Incoming/Raw Material Specialist is an exempt level position with responsibility to be part of the team responsible for Warehouse activities that will… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports ... Participates in Regulatory Inspections Other duties as assigned Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …tracking, follow-up, and reporting / trending Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action Reports. ... Other duties as assigned Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Review and assess Corrective and Preventive Actions Reviews and approves validation documentation Reviews and assesses deviations; includes tracking, follow-up and ... reporting/trending Reviews manufacturing and support records to certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk through audits of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Metrology Specialist as part of the Maintenance & Metrologyteam based in Raritan, NJ. Role ... for working with groups to provide start-up, commissioning, and qualification/ validation support of instrumentation and systems including on-the-floor troubleshooting… more
- Tris Pharma (Monmouth Junction, NJ)
- …by Laser Diffraction/Sieve Analysis, Bulk + Tapped density, cleaning verification/ validation according to analytical methods, United States Pharmacopeia (USP) ... procedures in GMP-regulated lab environment. Analyze + interpret test results. Operate analytical instruments incl High-Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet Visible… more
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