Novo Nordisk
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The Deviation Leader/Coordinator is responsible for overseeing deviation investigation and CAPA management processes, fostering a learning culture, and ensuring regulatory compliance within the organization. This role involves leadership, supervision, and cross-functional collaboration to maintain quality standards and address operational deviations effectively.
Support operations for Quality Control at a biologics manufacturing facility by assisting in process and equipment improvement programs, creating technical reports, reviewing quality records, providing training support, and more. Requires experience in Technical Writing and understanding of cGMPs and quality regulations.
Responsible for overseeing strategic processes, business partnering, finance partnering, investment controlling, and risk reporting at Novo Nordisk's manufacturing facility in West Lebanon, NH. Drive improvement initiatives, analyze financial data, prepare management reports, and lead investment project budgets. Ensure proper financial governance and risk management practices are in place.
Establish and lead a satellite team in Manufacturing Development Life Cycle Management for a pharmaceutical production site. Drive strategic activities to ensure seamless integration of new products without disrupting existing production. Maintain quality specifications, regulatory documentation, and drive a safe workplace culture. Coordinate with internal and external stakeholders to meet quality and safety requirements.
The Deviation Investigator-Writer II is responsible for investigating and writing deviations to the manufacturing process and other operational problems in API manufacturing. They lead investigations, collaborate with cross-functional teams, conduct root cause analysis, and implement corrective actions to ensure compliance with regulatory standards and quality principles. This role plays a key part in the Deviation Response Team and upholds quality priority principles within the organization.
The Manufacturing Area Specialist I position at Novo Nordisk involves supporting manufacturing operations with a focus on training, documentation, deviations, change control, and projects. Responsibilities include coordinating process and equipment improvements, reviewing quality records, generating deviation responses, driving investigations, and training technicians on processes and quality management systems. The role also involves liaising between production support and manufacturing, creating and revising documentation, conducting root cause analysis, incorporating process improvements, and supporting quality systems and Health Authority inspections.
Support the facilities team in completing quality issues, participating in projects, and ensuring regulatory compliance. Maintain performance metrics and review standard operating procedures. Perform job duties ethically and in compliance with healthcare laws. Other duties as required.
Works closely with Laboratory personnel to support repairs, preventive maintenance & calibration of laboratory instrumentation. Responsible for activities related to BMS & alarm handling. Executes work according to schedule & department plan. Maintains training qualifications on time. Follows safety and environmental requirements in the performance of duties.
The Environmental Health and Safety Associate at Novo Nordisk is responsible for managing site EHS policies, conducting safety inspections, providing training, and supporting audits. They also manage environmental, health, and safety information for chemicals used at the facility and ensure compliance with regulations. This role plays a crucial part in maintaining a safe work environment and promoting a culture of safety within the organization.
About the Department
Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for ...
The IIoT Integration Engineer III is responsible for providing technical expertise and support for data and digitalization efforts. They will build and maintain infrastructure for data connectivity/flow and collaborate with cross-functional teams.
This position is responsible for supervising personnel and operations involved in applicable department, ensuring compliance with cGMPs and Quality regulations. It also involves training and developing Manufacturing Technicians, preparing documentation, and supporting equipment validation and improvement programs.
Lead technical analysis, process development/improvements & quality topics. Responsible for investigations, coaching personnel, analyzing data, tracking corrective actions, developing SOPs, and supporting global sites with investigations. Must follow safety & environmental requirements and interact with various departments.
This position is responsible for supervising personnel and operations involved in applicable department. Requires adherence to cGMPs, manufacturing practices and procedures, and compliance with Quality regulations.
Provide leadership and support in attaining a safe working environment, provide direct support for production and maintenance, collect and report environmental data.
This position has primary responsibility to support manufacturing operations. Focus areas may include Training, Documentation, Deviations, Change Control, and Projects. Drives the coordination and execution of process and equipment improvement programs, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems.
About the Department
Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications.
What we offer you:
- Leading pay and annual performance bonus for all positions
- 36 Paid days off incl...
Lead a team of project management professionals in executing manufacturing suite robustness and capacity portfolio. Responsibilities include team development, project delivery, budgeting, and planning. Ensure alignment with site strategy and drive project prioritization. Communicate risks and resource constraints effectively.
This role is to support and maintain in-house computer systems, desktops, peripheral devices, and network components. Troubleshoot problems in a timely and accurate fashion and provide end user training and assistance where required.
Responsible for supporting building utility systems and related equipment. Perform troubleshooting, repair, and maintenance of facilities-related systems. Ensure all maintenance tasks are completed on time and in compliance with standard operating procedures. Perform building repairs and maintain GMP compliant paperwork.
