- 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
- 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
- Aequor (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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The QA Specialist II - Engineering/ Validation is responsible for cGMP compliance ensuring all FDA regulations, internal procedures/specifications, and other ... are adhered to as it relates to review and approval of engineering/ validation specific documentation. He/she must ensure all equipment installed, qualified or… 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. (Rahway, NJ)
- …clinical supply manufacturing facility in Rahway, New Jersey.The Process Engineer role at the Specialist level will serve as a leader in the FLEx Oral Solid Dosage ... Oral Solid Dosage GMP facility.Experience with Commissioning, Qualification and Validation .#EBRG#VETjobs NOTICE FOR INTERNAL APPLICANTS In accordance with Managers'… more
- Merck & Co. (Rahway, NJ)
- …job that provides both technical and project management responsibility. The Specialist - Manufacturing Automation position will report to the Director, Engineering, ... production, utility systems and associated infrastructure.- Responsibilities of the Specialist - Manufacturing Automation include the following:Site Operations (GWES)… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture… more
- Novo Nordisk Inc. (Durham, NC)
- …medical device industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General knowledge of ... quality oversight & on floor production support preferred Good written & verbal communication skills required Basic computer skills in MS Office, PowerPoint, Word, Excel, etc. required Knowledge of cGMPs in manufacturing required, pharmaceutical manufacturing… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded Associate Specialist Automation Technician who can help drive our Strategic Operating Priorities.- The ... manufacturing systems, in partnership with maintenance, technical operations, operations, validation , and quality personnel.Performs routine system monitoring and troubleshooting.Performs… more
- Merck & Co. (Rahway, NJ)
- …in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng position will report to the Director, ... ensure compliance with regulatory requirements.Execute and develop appropriate system validation , change control, and testing documentation.Maintain familiarity with system… 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. (Durham, NC)
- …problems solving Understand & execute GMP & compliance protocols for instrument validation Executes work according to schedule & department plan Evaluates instrument ... performance & responds to potential issues Contributes to process confirmations Maintains training qualifications on time. Supports training others as required Follow all safety and environmental requirements in the performance of duties Other… 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
- 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)
- …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
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Validation department at Regeneron is adding to their team! The **QA Validation Specialist - External Partners** coordinates the equipment, systems, and ... the following minimum amounts of experience required for each level: + Associate QA Validation Specialist : 0-2 years + QA Validation Specialist : 2+ years… more
- Regeneron Pharmaceuticals (Troy, NY)
- …company manufacturing standards policies and procedures. The day to day of a QA Validation Specialist could include, but are not limited to, the following: + ... Sciences and the following years of relevant experience for each level: + Assoc. QA Validation Specialist : 0 - 2 years + QA Validation Specialist : 2+… more
- United Therapeutics (Silver Spring, MD)
- …diseases, and other orphan diseases. **How you'll contribute** The Senior Validation Specialist or Engineer, Equipment will perform activities independently ... teams, including developing and reviewing protocols and final reports, representing validation on project teams, and preparing validation change control… more
