Quality Assurance Area Specialist II - OFP
Company: Novo Nordisk
Location: Durham
Posted on: July 6, 2025
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Job Description:
About the Department For more than 100 years, Novo Nordisk has
been tackling the unmet medical needs of people living with serious
chronic diseases, such as diabetes & obesity. 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 Emerging
Technologies -Solid Dosage Forms US facility in Durham, NC is a
194,000 square foot tableting and packaging facility that supports
the production of our innovative oral treatments for patients with
type 2 diabetes. SDF maintains a curious and pioneering spirit,
harmonious with our growing pipeline of new products and emerging
technologies. 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 Perform quality review &
approval of Batch Production Records (BPRs), Change Requests
(CR's), Deviations & other documentation (in conjunction with LoB)
& QA presence & process confirmation on shop floor. Handle release
of raw materials & provides quality oversight, review & approval of
validation activities associated with minor changes to existing
systems. Perform archiving duties & QA presence & process
confirmation on shop floor. Relationships Reports to Manager,
Quality Assurance. Essential Functions Ensure site compliance with
Regulations, International Organization for Standardization (ISO)
standards, corporate & local SOPs Review & approve documentation
for Quality approval – components/raw material, batch records,
change control requests, deviations & validation documents Perform
QA presence & process confirmation on shop floor Participate in
project teams as a quality resource Support, review & approve
investigations & root-cause analysis Participate in process
confirmations & Go Look Sees Evaluate trend & report data for QMRs
& APR reports Follow all safety & environmental requirements in the
performance of duties Other duties as assigned Physical
Requirements May 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. Qualifications Bachelor’s degree in life
sciences or related field of study from an accredited university
required May consider an Associate’s degree in life sciences or
related field from an accredited college with a minimum of five (5)
years of experience in QA or related quality experience May
consider a High School Diploma or GED with a minimum of seven (7)
years of experience in QA or related quality experience Minimum of
three (3) years of QA &/or quality related or API experience
required, preferably in the pharmaceutical industry Understanding
of cGMP manufacturing & production processes & how to apply
required Understanding of the Batch Review Processes required
Understanding of validation preferred Understanding of quality
management systems required Understanding of quality oversight & on
floor production support required Knowledge in Quality Management
Systems required Demonstrated knowledge of critical controls &
input/output requirements for NNPILP processes preferred Excellent
written & verbal communication skills required Basic computer
skills in MS Office, MS Project, PowerPoint, etc. required Auditing
experience with certification a plus Experience in the use of Six
Sigma & LEAN tools a plus 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.
Keywords: Novo Nordisk, Chapel Hill , Quality Assurance Area Specialist II - OFP, Science, Research & Development , Durham, North Carolina
