Quality Assurance Area Specialist III (QA for Warehouse & Logistics)

Novo Nordisk

Clayton, NC

JOB DETAILS
SKILLS
Asepsis, Auditing, Biology, Biotech and Pharmaceutical, Change Control, Change Requests/Orders, Chronic Disease, Coaching, Code of Federal Regulations, Communication Skills, Computer Skills, Computer Systems, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Dental Insurance, Diabetes, Disability Insurance, Disease, Document Management, Documentation, Drug Manufacturing, Environmental Regulations, Equipment Validation, GMP (Good Manufacturing Practices), Healthcare, High School Diploma, ISO (International Organization for Standardization), Identify Issues, Input/Output, Insurance, Laboratory Equipment, Lean Six Sigma, Life Insurance, Logistics, Maintain Compliance, Manufacturing, Medical Equipment, Mentoring, Obesity, Presentation/Verbal Skills, Process Validation, Product Marketing, Product Reviews, Project/Program Management, Quality Assurance, Quality Control, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Risk Management, Root Cause Analysis, Safety Training, Standard Operating Procedures (SOP), Sterilization, System Validation, Team Player, Time Management, Trend Analysis, Tuition Fees, Validation Documentation, Vendor/Supplier Evaluation, Vendor/Supplier Management, Warehousing, Writing Skills
LOCATION
Clayton, NC
POSTED
Today
About the DepartmentAt 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 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 AwardsAt 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 PositionEnsures plant systems batch release, and/or relevant quality processes are compliant with regulations. Has product release authority , if role is in batch release. Quality oversight, review & approval of validation activities and documents associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems. Presentation, support & coaching for audits & inspections. Review & approval of complex Change Requests (CR's), Deviations (DVs), CAPAs & other documentation. Performs Self Audits (in conjunction with line of business (LoB)); Quality Assurance (QA) presence & process confirmation on shop floor. Site Clayton Process Representative, as assigned. Able to support all processes & functions in Department. Trends and reports data as applicable.RelationshipsReports to Senior Manager, Quality Assurance.Essential Functions* Make decisions on quality & compliance issues with little guidance* Participate in process group activities as assigned & leads local implementations* Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs)* Lead improvement activities/improvement of standards within the assigned process* Review & approves change control documentation, SOPs & other current good manufacturing practice (cGMP) documentation* Provide coaching to Site regarding quality & compliance related activities* Supports, reviews & approves complex cross-functional investigations & root-cause analysis* Facilitates sharing of regulatory & compliance expectations* Reviews & approves complex DVs, CRs, (SOPs), trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports* Eliminates non-value-added practices* Follow all safety & environmental requirements in the performance of duties* Other accountabilities, as assignedPhysical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.Qualifications* High School Diploma or equivalent (GED) required* Bachelor's degree in Life Sciences or a relevant field of study from an accredited university preferred. *If hired as a AQP, Bachelor's degree in Life Sciences or a relevant field of study from an accredited university required* Minimum of seven (7) years of QA and/or related quality experience in manufacturing, utility and/or packaging systems, preferably in the pharmaceutical or medical device field required* Demonstrated expertise in Regulations & quality systems in one or more of the following: product disposition, DV/CAPA, Change Control, Audits, Supplier Management, Project Management, Validation, laboratory method and equipment validation, warehouse/logistics, and IT preferred* Quality Risk Management experience required* Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity required* Experience in use of Risk Assessment & Vendor Assessments during evaluation of change controls, deviation and validation activities required* Expert in cGMP documentation practices. Requires a minimum of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation preferred* Excellent troubleshooting skills; able to identify root cause of problem required* Demonstrated knowledge of critical controls & input/output requirements for processes in these areas: semi-finished manufacturing, finished manufacturing QC, IT & process utilities preferred* Excellent written & verbal communication skills required* Auditing experience with certification preferred (internal/external) required* Experience with LEAN, Six Sigma & other continuous improvement methodologies required* Expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation) preferred* Knowledge of statistical methods (hypothesis testing, sampling, trending, CpK, etc.) required* Expert in utilizing appropriate root-cause analysis tools & techniques preferred* Experience with Risk Assessment & Risk Management required* Demonstrated excellence with time management, organizational & project management skills requiredWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today.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.

About the Company

N

Novo Nordisk

Working at Novo Nordisk

 

Life-changing careers

Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.

Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.

 

We are inspired by life

We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.

We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.

 

Together we drive change

Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.

We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.

 

Together, we are life-changing

Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.

 

Your development starts here

We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.

It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile. 

With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.

In the video above, meet  Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.

 

Who we are

We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.

Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering  scientific breakthroughs, expanding  access to our medicines , and working to prevent and ultimately cure diabetes.

With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.

COMPANY SIZE
2,500 to 4,999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1923
WEBSITE
https://www.novonordisk.com/