Senior Quality Assurance (Qa) Area Specialist I

Novo Nordisk Clayton , NC 27527

Posted 2 months ago

About the Department

At Novo Nordisk, we want to make a difference. For nearly 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. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility, you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity products over the next decade; we have recently completed construction of a 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC. Our new API facility houses the fermentation, recovery and purification of GLP1 ingredients for Novo Nordisk's innovative oral products. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?

We are recruiting for multiple roles

Position Purpose

Design & develop quality & compliance set-up for global systems during DAPI-US project. Train equipment & systems work package in relevant quality related issues. Ensure compliant execution & monitoring. Drive corrective actions & quality improvement initiatives.

Accountabilities

  • Oversee & approve user requirements for assigned process

  • Formulates continuous improvement tools for Quality Assurance (QA) Compliance operations

  • Develop assigned process monitoring program & cleaning procedures

  • Ensure compliance with regulations, ISO standards & corporate & local SOPs

  • Coordinate Internal & Supplier Audit program

  • Develop & implement metrics for Quality System process improvements

  • Assist in plant-wide training on regulations, Quality systems & procedures

  • Coordinate tasks of QA Compliance Specialists to assure compliance with company procedures, policies & objectives

  • Prepare & approve documents regarding QA department's related activities

  • Support, review & approve cross-functional investigations & root-cause analysis

  • Review & approve validation & change control documentation

  • Ensure quality & compliance with company procedures, policies & objectives

  • Reporting of project performance to the relevant stakeholders

  • Perform other duties as assigned

Required Qualifications

  • BA/BS in chemistry, microbiology or related pharmaceutical field

  • Minimum of five (5) years of chemistry, validation or engineering experience in the pharmaceutical industry or related field

  • GMP experience

  • Experience reviewing & approving validation protocols

  • Expert knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs within Automations

  • Specialist in assigned Automation processes (Delta V, SCADA, MES, SAP, PRISM, LIMS, PLC, Vision, Barcode scanning & back-bone IT infrastructure)

  • Solid network within PS & related areas within NN or strong Pharmaceutical Industry experience

  • Good knowledge of Six Sigma or LEAN (cLEAN) principles

  • Auditing experience with certification preferred

Desired Qualifications

  • Experience managing projects

  • Good stakeholder management & change management skills. Strong in setting direction & describing framework. Solid structural & follow up skills

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility

  • Routinely operates & inspects manufacturing equipment using hands. Must be able to be on feet for up to a 12 hour shift

  • Constantly positions self to transfer materials within manufacturing environment. Frequently moves about the building to access other personnel & operational areas

  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procurement motorized vehicle license

  • Occasionally ascends/descends a ladder to service equipment. Works atop elevated positions at heights

  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle

  • Occasionally works around odorous and/or hazardous materials. Occasionally performs critical job functions in extremely cold work environments

  • Occasionally positions self within confined spaces for inspection, repair & maintenance of equipment

  • Able to work in loud noise environments with hearing protection

  • Able to work in an open office environment with the possibility of frequent distraction

  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

Relocation is available for this role

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status

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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Senior Quality Assurance (Qa) Area Specialist I

Novo Nordisk