Overview
Consumer Safety Inspector Jobs in Long Prairie, MN at USDA Food Safety and Inspection Service
Director, Inspection/Packaging
Facility: Manufacturing
Location: Bloomington, IN, 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.
Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.
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
In general, this position is responsible for increasing the ratio of value to non-value activities and eliminating waste in the overall production and supply chain from start to finish, for a defined area or operation, while being held accountable for processes, personnel, safety, compliance and meeting or exceeding the client requirements within their operational area.
Relationships
Reports to Sr. Director.
Essential Functions
Is accountable for the performance and results of multiple related teams
Develops departmental plans, including business, production and/or organizational priorities up to 6-18+ months in advance
Decisions are guided by policies, procedures, resource availability and functional objectives
Provides leadership and direction through managers
Provides technical guidance to employees, colleagues and/or customers
Collaborates and communicates with support functions
Reviews and approves GMP documentation while ensuring safety and GMP quality compliance
Supports and leads continuous improvement projects
Creates the strategic direction of Operations and customer-oriented process to maximize customer satisfaction, while optimizing cost effectiveness
Hires, trains, motivates, leads, develops, and evaluates staff
Takes corrective action as necessary on a timely basis and in accordance with company policy
Ensures compliance with current federal, state, and local regulations
Consults with Human Resources Department as appropriate
Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results
Designs and implements new or improved systems and processes to drive improvement in levels of customer satisfaction
Manages and leads key initiatives for the site’s working capital management
Is responsible for driving performance to target in the key indicators for operations-oriented measures
Creates and supports, the implementation and execution of best practice processes such as Lean, Six Sigma, CAPA, ERP/JDE, SIOP
Maintains effectiveness of the Quality System components relevant to this position
Provides key input and reports that support financial revenue budget and reporting
Responsible for the data integrity, management and communication of all operations related plans and schedules at the facility
Drives compliance with all applicable corporate and regulatory SOP and cGMP guidelines for their area of responsibility
Leads team members to improve and reinforce performance of others
Takes responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
Works with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development
Follow all safety and environmental requirements in the performance of duties
Other duties as assigned
Physical Requirements
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled.
Development Of People
Supervisory.
Qualifications
Bachelor’s degrees in science, engineering, or technical study are preferred
Master’s degree preferred
8+ years of leadership experience
Technical Requirements
Ability to see and hear, read, and write clear English
Excellent written and verbal communication skills with internal and external customers
Ability to communicate complex technical information to non-technical audiences
Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution
Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines
Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process
Experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones
Well organized with ability to handle and direct multiple activities across departments simultaneously
Ability to use Excel, Word, and other office systems, as well as programs for multiple pieces of manufacturing equipment
Ability to peer review data to ensure data is well organized with complete documentation
Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions
Ability to problem solve to initiate and execute/monitor corrective action
Ability to write SOPs, batch production records and reports independently
Ability to work with and lead other groups to develop, qualify and transfer methods, and drive complete investigation, deviation, and change control practices
Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify and transfer methods accordingly
Strong interpersonal and presentation skills to discuss technical concepts internally and with clients
Ability to learn and use software packages (e.g., TrackWise®, pcMRP, ComplianceWire®)
Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.)
Can effectively back-up Senior Director, Operations to address technical or business issues
Provides reliable/defendable interpretations of regulatory guidance for the customer and can defend these positions to regulatory agencies
Behavioral Requirements
Shares own ideas in a compelling manner that gains commitment from others
Inspires and persuades others to voluntarily follow direction
Negotiates skillfully and professionally and persuades others to approach issues in the same manner
Anticipates reactions and positions of others and plans accordingly. Mentors team to do the same
Takes a proactive approach to shape and influence internal and external executive stakeholder expectations
Serves as a liaison between different stakeholder groups across departments
Effectively aligns and influences the interests of multiple stakeholders (client programs and company) with different priorities to quickly drive complex decisions
Leadership Requirements
Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus
Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline
Manages strategic or continuous improvement activities with the team, across teams within the department, or across multiple departments within the site. Coordinates with teams in other departments and across the business unit
Helps identify department objectives to align with site goals. Regularly communicates to team, department, and company about department priorities and how aligned
Makes implementation plans and assignments that allocate cross functional resources appropriately to complete objective and provide development opportunities
Anticipates challenges and opportunities and adjusts contingency plans for department initiatives and team’s project
Identifies initiatives with relevant milestones and schedules to effectively manage the progress and performance of the team and own work developing metrics to monitor performance to goal
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.
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Title: Consumer Safety Inspector
Company: USDA Food Safety and Inspection Service
Location: Long Prairie, MN
