- Merck & Co. (Durham, NC)
- …and safe maintenance and repair of equipment using Hazardous Energy Control Procedures. Compliance with current good manufacturing procedures(cGMP), safety and ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Eisai, Inc (Nutley, NJ)
- …technological functions and compliance controls.Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate ... Eisai's information governance program, including JSOX compliance .Maintain accurate compliance documentation and advise control owners.Assess risk, evidence… more
- Merck & Co. (Durham, NC)
- …Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures Compliance with current good manufacturing procedures (cGMP), ... written documentation of activities. Accountable for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Novo Nordisk Inc. (Boulder, CO)
- …requirements Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance to change control process requirements across NN Boulder ... Specialists ensuring the tactical execution of the internal and external (CMO) change control and deviation processes at NN Boulder, specifically in the role of… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide...and ensuring that all functions are being performed in compliance with SOPs. This is a full-time position: Monday… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring for a Quality Assurance Document Control . The Quality ... batch records and finished product. The Quality Assurance Document Control individual acts as the primary liaison to our...a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer,… more
- Catalent (St. Petersburg, FL)
- Compliance ManagerPosition SummarySt. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and Catalent employee. … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Environmental, Health, and Safety (EHS) initiatives with a focus on environmental compliance and reporting. Priority reports include air permitting, Tier II & ... Hazardous Materials reporting, and wastewater discharge compliance . Develops and improves site policies, prepares and submits regulatory reports, independently track… more
- Novo Nordisk Inc. (Durham, NC)
- …completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, ... of all deliverables. Relationships Manager. Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC… 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 ... guidance with demonstrated effectiveness in maintaining QC processes for compliance with regulationsKnowledge of Statistical programming preferredExcellent presentation skills… more
- Catalent (Harman, WV)
- …Supply Chain planning/scheduling, technology, material availability, procurement, logistics, operational compliance , and inventory control .Assist in developing a ... Warehouse will lead a shift consisting of Warehouse Materials Control Associates and Materials Services Associates. Responsibilities include: project participation,… more
- Novo Nordisk Inc. (Durham, NC)
- …& participates in systematic 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… more
- Catalent (St. Petersburg, FL)
- …functional areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the area/site. ... aspects related to Quality Systems, Finished Product Batch Release, Change Control , Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of… more
- Merck & Co. (Rahway, NJ)
- …conformance to all applicable policies and procedures of the Company and compliance with all governing regulations.Responsibility for Quality Control functions ... Leadership Behaviors and provides a leadership example for the team.Assures compliance with established policies/procedures of the Division and Corporation and… more
- Catalent (San Diego, CA)
- …departments to troubleshoot technical issues.Collaborate with Quality Assurance and Quality Control on analytical method validation and compliance issues. ... studies to determine if methods are suitable for transfer to Quality Control .Communicate results both internally and externally through oral and written updates and… more
- Merck & Co. (Rahway, NJ)
- …This will also require close collaborate with the development engineers & chemists, compliance representatives, and other team member. This role will be part of the ... Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP… more
- Merck & Co. (Rahway, NJ)
- …Position sits in Rahway, NJ and is a 12-hour rotating shift. Position Duties: Compliance - Accountable for creating and sustaining a culture that ensures that ... compliance (Safety, Environment, cGMP, etc.) are imperatives for the...reverse osmosis skids, vapor compression stills).Automated systems (eg, distributed control system, programmable logic controllers).Maintenance equipment (eg, tools and… more
- BioAgilytix (Boston, MA)
- …according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of ... data and documentation generated by the Bioanalytical Operations group in support of regulated studies (eg GLP, GMP) and non-regulatedIdentify deviations, OOS and OOT associated with Bioanalytical Operations data as applicableIssue QC review observations and… more
- Merck & Co. (North Wales, PA)
- …Responsibilities (including but not limited to):Ensure Sarbanes Oxley controls compliance is maintained throughout the grants generation, payment execution, ... any system discrepancies.Participates in internal and external audits and Sarbanes Oxley control testing.Maintenance of all SOPs for all GMS procedures and provide… more
- Merck & Co. (Rahway, NJ)
- …performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, ... close out.Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures,… more
