SENIOR QUALITY ASSURANCE AREA SPECIALIST I
Company: Novo Nordisk
Location: Clayton
Posted on: September 28, 2024
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Job Description:
About the DepartmentAt Novo Nordisk, we are helping to improve
the quality of life for millions of people worldwide. 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 newer Active Pharmaceutical Ingredients (API)
facility in Clayton, NC sits on 825,000 square-feet of
state-of-the-art equipment, and houses the Fermentation, Recovery
and Purification in the production of ingredients for Novo
Nordisk's innovative oral products. At API, 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 positionsAll employees enjoy generous paid time off
including 14 paid holidaysHealth Insurance, Dental Insurance,
Vision Insurance - effective day oneGuaranteed 8% 401K contribution
plus individual company match optionFamily Focused Benefits
including 12 weeks paid parental & 6 weeks paid family medical
leaveFree access to Novo Nordisk-marketed pharmaceutical
productsTuition AssistanceLife & Disability InsuranceEmployee
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 PositionResponsible for the
production activities & validation. Ensures relevant compliance
issues are addressed & handled in close collaboration with
production. Main duties include review of batch reports & release
of API materials, deviations, change controls, review & approval of
SOPs, QA presence & process confirmation on shop floor &
improvement of Quality processes.RelationshipsManager, Quality
Assurance.Essential FunctionsEnsure that the current NN procedures
& requirements from health authorities are reflected in the
validation planning & quality related decisionsSupport validation
projects in communicating Novo Nordisk project quality requirements
& assessing suppliers' ability to support test/qualification
activities to ensure that Novo Nordisk requirements & expectations
are clearSupport projects in solving quality related issues, act
quickly in order to come to a decision, & communicate quickly &
clearly regarding such decisionsSupport evaluation of the quality
level during the project by performing spot checks of validation
documentationPerform activities related to Batch review &
releaseReview & approve API/Intermediate Batch documentation in
various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow,
etc.)Ensure site compliance with Regulations, ISO standards, &
Corporate/Local SOPsReview & approve change control requestsReview
& approve deviations guidance to departments regarding quality &
related activitiesParticipate & provide input to root-cause
analysisParticipate in process confirmations & quality
oversightAuthorized person according to Novo Nordisk Quality
ManualOther accountabilities, as assignedPhysical RequirementsMay
move equipment &/or supplies weighing up to 33 pounds within
the facility using various body positions. May be required to be on
your feet for up to a 12-hour shift. 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.QualificationsBachelor's Degree in Life
Sciences, Engineering, or related field requiredMinimum of five (5)
years of experience within the pharmaceutical industry requiredGood
Knowledge of cGMP manufacturing & production processes & how to
apply requiredGood Knowledge of the Batch review Processes
requiredGood Knowledge of quality management systems requiredGood
Knowledge of quality oversight & on floor production support
requiredStrong knowledge level in cGMP's & validation
requiredStrong knowledge in Quality Management Systems requiredMust
be ability to perform tasks independently, accurately & within
defined time frames requiredAbility to willingly work with
customers/stakeholders in a cooperative manner requiredStrong
written & verbal communication skills requiredStrong computer
skills in MS Office, PowerPoint, Word, Excel, etc. requiredProven
expertise in planning & organizing tasks preferredWillingness to
assist others in developing plans in a cross-functional environment
preferredInnovative approach to establishing priorities preferredWe
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.
Keywords: Novo Nordisk, Rocky Mount , SENIOR QUALITY ASSURANCE AREA SPECIALIST I, Other , Clayton, North Carolina
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