- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... Control (QADC) Supervisor. The QADC Supervisor will supervise the team and activities associated with batch record documentation, reviewing and approving batch records, and releasing batch records and finished product. They will have a deep understanding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oversight of the transmittal of trial and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF). ... operational delivery aspects of the protocol and take a document review & coordination role for the protocol and...Reconcile the CRO-generated TMF document trackers with the document archive. Identify… more
- Merck & Co. (Durham, NC)
- …GLIMS sample rejections. - Equipment Calibration and ManagementFiling data sheets and document control of logbooks - Other duties requested by Management.In ... to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they… more
- Aequor (Thousand Oaks, CA)
- …expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills ... them in a very detail oriented manner.Job Details: Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops,… more
- Insmed Incorporated (Bridgewater, NJ)
- …with product quality complaints in regulated industry.Direct involvement in Document Control , and Deviations/CAPAs, in pharmaceutical or medical ... device industryThorough knowledge of relevant cGMP's and Good Documentation PracticesPreferred experience with Veeva Vault Quality Management SystemFamiliarity of pharmaceutical product manufacturing processes and medical deviceExcellent verbal and written… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …understanding of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes. Working ... independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the lead in managing Equipment Lifecycle Management processes, including overseeing change control procedures. Document and manage records for corrective and ... Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration. Key Responsibilities Develop User Requirement… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …as it applies to CSV Perform assigned Quality Systems activities including Document Management system, Change Control , Deviations, and CAPA's Writing and/or ... revising procedures applicable to CSV activities Work in collaboration with the Engineering group to prepare the validation, requalification, and maintenance program CSV Service Delivery Management: Facilitate the seamless transition and handover of projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …flow processes, test scripts, functional specification, training documentation, etc. Ensure document integrity and version control by leveraging SharePoint ... specifications for Veeva CRM. Collaborate with business stakeholders to gather and document business needs, objectives, and processes related to Veeva CRM as it… more
- Aequor (Thousand Oaks, CA)
- …with diverse functional areas including Supply Chain, Manufacturing, Quality Control , Regulatory, Quality Assurance, Quality Engineering, International Quality and ... and reports Execute transactions in relevant GMP computer-based systems (change control , LIMS, etc.) Adeptly manage time-sensitive activities independently Win What… more
- Merck & Co. (Rahway, NJ)
- …Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in ... thinking and technical writing skillsProficient in MS Office Platform and document storage systemsAn ability to foster innovation, creativity, and self-initiative… more
- Merck & Co. (Rahway, NJ)
- …support several automation systems across the Rahway Site including ABB Distributed Control Systems, environmental control systems and equipment utility metering ... thinking and technical writing skillsProficient in MS Office Platform and document storage systemsAn ability to foster innovation, creativity, and self-initiative… more
- Merck & Co. (North Wales, PA)
- …and validation plansParticipate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to ... internal/external labs and data transfer for biospecimen- based studiesParticipate in quality control assessments and ensure integrity of study data for reports and… more
- Drainage Solutions Inc. (Franklin, IN)
- Position Summary: Sale of pipe, valves, fittings, geotextiles, geogrids, erosion control and drainage products by phone, internet or in person while maintaining a ... of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills or...the minimum levels of knowledge, skills or abilities. This document does not create an employment contract, implied or… more
- Aequor (Golden Valley, MN)
- …flexibility related to the analysis of samples or preparation for Medallion Labs Document results and review data generated by LIMS or instrumentation to maximize ... Medallion and ISO 17025 quality requirements o Identifying and addressing quality control issues o Completing quality investigations in a thorough and timely manner… more
- Insmed Incorporated (Bridgewater, NJ)
- …submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission ... related documents in the Company's electronic document management system (EDMS).ResponsibilitiesRESPONSIBILITIES:Support regulatory submission activities associated with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …works closely with statistical programmers in statistical analyses execution, quality control , and data derivation; collaborates closely with data manager to ensure ... by providing input for the interaction or by writing the interaction document . May participate in meeting or teleconferences with Health Authorities Qualifications:… more
- Catalent (Manassas, VA)
- …complete appropriate details; Report any housekeeping issues that need attention. Document all areas of non-compliance and ensure corrective actions are completed. ... Responsible for ensuring compliance to FDA and cGMP standards for Quality Control , including continuous training. Perform cleaning verification by ATP, EMP testing;… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …deviations, and implements corrective/preventative actions via change requests, document change controls, and developing training. Essential Functions Liaison ... cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control , Facilities, and Quality Assurance Performs all job duties… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …engineers in development of metrological specifications for new equipmentDevelop control charts and statistical process controls for calibration standards and ... parametersThorough knowledge and application of measurement uncertaintyAbility to develop, document , and implement new measurement methods and test systems.Demonstrated… more
