Quality Assurance Area Specialist I - SDF

Novo Nordisk; Durham (NC); Presencial; USD 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Descripción de la vacante

Novo Nordisk in Durham, NC, USA, is hiring for a QA role focused on batch records, change controls, deviations, and documentation review.

You will support investigations, audits, and continuous improvement initiatives while ensuring compliance with pharmaceutical regulations and SOPs. Join a collaborative team dedicated to quality across our Durham site.

Formación

• Associate’s degree in life sciences or related field; Bachelor’s degree preferred.
• Minimum of two (2) years QA or quality related, or API experience.
• Quality experience preferred.
• General knowledge of pharmaceutical regulations & quality systems preferred.
• Knowledge of Quality and one or more of: Aseptic Production, QC, Production Support, etc.
• Excellent written & verbal communication skills required.
• Basic computer skills in MS Office, MS Project, PowerPoint.

Responsabilidades

• Ensure site compliance with Regulations, ISO standards, SOPs.
• Review and approve documentation for Quality approval – batch records and more.
• Support investigations and root-cause analysis using LEAN tools.
• Participate in process confirmations and Go Look Sees.
• Evaluate data for QMRs and APR reports.
• Perform QA review of customer complaint investigations.
• Support internal/external audits and inspections.
• Train AP and FP members responsible for investigations.

Conocimientos

QA experience

Regulatory knowledge

Documentation review

LEAN tools

Communication skills

Educación

Associate's degree in life sciences

Bachelor's degree preferred

Herramientas

MS Office

MS Project

PowerPoint

Descripción del empleo

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.

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

Ensure Batch Production Records (BPRs) and/or relevant quality processes are compliant with regulations and/or relevant standard operating procedures (SOP's) and guidance. Accountable for Quality review & approval of Change Requests (CR's), Deviations & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor.

Relationships

Reports to Manager, QA.

Essential Functions

• Ensure site compliance with Regulations, International Organization for Standardization (ISO) standards, corporate & local SOPs
• Review & approve documentation for Quality approval – batch records and other documentation
• Support, review & approve investigations & root-cause analysis using LEAN tools and continuous improvement
• Participate in process confirmations & Go Look Sees
• Evaluate trend & report data for Quality Management Reviews (QMRs) & Annual Product Review (APR) reports
• Perform QA role to review and approve local production related Customer Complaint Investigations (escalate if necessary)
• Participate in & support the audit management team as needed during internal, external audits and inspections
• Responsible for training of AP and FP members responsible for conducting investigations
• 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 colour vision based on role. May require the ability to work in loud noise environments with hearing protections.

Qualifications

• Associate’s degree in life sciences or related field from an accredited college required. Bachelor’s degree preferred
• May consider a High School Diploma or GED with a minimum of six (6) years of experience in QA or related quality experience
• Minimum of two (2) years QA and /or quality related, or API experience required, preferably in the pharmaceutical industry
• Quality Experience preferred
• General knowledge of pharmaceutical regulations & quality systems preferred
• Knowledge of Quality and one or more of the following: Aseptic Production, Business Support, QC, Production Support, Warehousing/Transport, API and/or Finished Production processes preferred
• Excellent written & verbal communication skills required
• Basic computer skills in MS Office, MS Project, PowerPoint, etc. required

We 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.