Associate Manager, Environmental Monitoring Sampling - Days
Clayton, NC, US
About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Responsible for supervising Environmental Monitoring personnel and activities for assigned areas of accountabilities Responsible for ensuring routine environmental monitoring, water, steam, and process air sampling is performed in accordance with cGMP, NNPILP and corporate policies. This role involves leading team of technicians and working collaboratively with other departments to ensure that environmental monitoring activities are completed accurately and in a timely manner.
Relationships
Reports to the Manager of Environmental Monitoring. Collaborates with internal stakeholders and occasionally with other Novo Nordisk production supply sites on best practices and processes. The Associate Manager will also work closely with vendors to ensure that all supplies and equipment are ordered and maintained in a timely and efficient manner.
Essential Functions
- Lead team in successful execution of environmental monitoring processes
- Coordinate with the responsible manager, stakeholders, and other teams on workload issues and priorities for assigned area of accountabilities
- Plan weekly and collaborate with stakeholders for assigned areas of accountabilities (IFP or API) to ensure resources are in place to execute EM responsibilities and the cycle plan
- Ensure tracking and reporting of Key Performance Indicators (KPIs)
- Communicate with stakeholders
- Ensure department documents are current and standardized, to include compliance with regulations, ISO Standards, and corporate and local SOPs
- Support hiring, training and development of EM Work Cell Leaders and Technicians
- Ensure data integrity of Pharmaceutical Environmental Monitoring System (PEMS) and global Laboratory Information Systems (LIMS), to include timely reporting of data for batch release
- Responsible for ensuring laboratory areas are inspection ready
- Follow all safety and environmental requirements in the performance of duties
- Other accountabilities, as assigned
Physical Requirements
Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)
Development Of People
Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required
- May consider an associate’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university with a minimum of five (5) years’ experience in a manufacturing organization required; aseptic manufacturing experience in a pharmaceutical environment preferred
- May consider a High School Diploma or equivalent with a minimum of seven (7) years’ experience in a manufacturing organization required; aseptic manufacturing experience in a pharmaceutical environment preferred
- Minimum of three (3) years of experience in a manufacturing organization required; aseptic manufacturing experience in a pharmaceutical environment preferred
- Minimum of three (3) years of direct supervisory experience required
- Strong working knowledge of database management systems preferred
- Proven expertise in the areas of environmental monitoring, water sampling, process air sampling, steam sampling, gowning practices and cGMP for classified production areas required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.