- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring for a Quality Assurance Document Control . The ... records, and release batch records and finished product. The Quality Assurance Document Control individual acts as the primary liaison to our customer's quality… more
- 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
- Catalent (St. Petersburg, FL)
- …Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control , Equipment/Facilities, Change Control , etc. ... Computerized System Validation (CSV) guidelines, policies, and procedures for control systems, automation, analytical equipment, and IT applications.Ensure that GxP… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and computerized systems.Knowledge of quality systems including exception management, change control , document control .Knowledge of operating and ... troubleshooting procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos that meet the requirements of the Quality Organization… more
- Aequor (Thousand Oaks, CA)
- …; previous technical writing experience ; regulated environment experience ; document version control experience ; excellent communication/writing skills ... be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to all NN GxP Support processes, including but not limited to ISOtrain, Document Control , and/or Audits and Inspections, as necessary Physical Requirements ... 10-20% overnight travel required. Qualifications Bachelors degree required; relevant experience may be substituted for degree, when appropriate; advanced degree and/or external certification (eg ASQ, PMI) preferred Requires a minimum of 7 years of… 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Quality Control Associate will serve as a strategic and tactical quality professional ... pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document … more
- Novo Nordisk Inc. (Boulder, CO)
- …Specialists ensuring the tactical execution of the internal and external (CMO) change control and deviation processes at NN Boulder, specifically in the role of ... as through other functions and routine networking opportunities. Essential Functions Change Control : Develops and maintains the Change Control process covering… 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …any system discrepancies.Participates in internal and external audits and Sarbanes Oxley control testing.Maintenance of all SOPs for all GMS procedures and provide ... and our Research & Development Division Business partners to develop and document process improvements and communicate any GMS process changes, enhancements, and… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …prescribe data handling, protection, and user provisioning controls- Identify, assess, monitor, document , and communicate potential quality issues in the way data is ... o Security and protection of organizational data assets o Access Control leveraging administrative controls of data access rights for cross-functional users… more
- CHRISTUS Health (Youree, LA)
- …in the development and implementation of specific procedures * Works with control and monitoring mechanisms, tools and techniques Health Information Documentation * ... between various stations or units * Discusses the functions, features and document flow of electronic documentation * Transcribes verbal orders; explains techniques… more
- CHRISTUS Health (Alex, LA)
- …in the development and implementation of specific procedures * Works with control and monitoring mechanisms, tools and techniques Health Information Documentation * ... between various stations or units * Discusses the functions, features and document flow of electronic documentation * Transcribes verbal orders; explains techniques… more
- Piper Companies (Titusville, NJ)
- …the production, testing and packaging of pharmaceutical productsDevelop, execute, and document equipment qualification protocols and test plans in accordance with ... computer system validation, FDA, IHC, compliance, regulatory, inspections, reporting, control systems, MES, manufacturing execution systems, GALP, good automated… more
