Quality Assurance Area Specialist I

Novo Nordisk

1+ years

Not Disclosed

Durham United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Quality Assurance (QA) Role

Location: Durham, United States

Department: Quality

Job Category: Quality

About the Department:

Novo Nordisk has been tackling unmet medical needs for over 100 years, focusing on chronic diseases like diabetes and obesity. With three pharmaceutical manufacturing facilities in North Carolina, including the Emerging Technologies - Solid Dosage Forms (SDF) facility in Durham, the company is committed to improving the quality of life for millions of people. The Durham facility, a 194,000 square foot tableting and packaging site, plays a pivotal role in producing innovative oral treatments for type 2 diabetes.

Benefits Offered:

Leading pay and annual performance bonus for all positions
Generous paid time off, including 14 paid holidays
Health, Dental, and Vision Insurance effective day one
8% guaranteed 401K contribution plus individual match option
Family-focused benefits, including 14 weeks paid parental leave and 6 weeks paid family medical leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance
Life & Disability Insurance
Employee Referral Awards

Position Overview:

The Quality Assurance (QA) Role ensures compliance with regulations for Batch Production Records (BPRs) and other relevant quality processes. This position will perform quality reviews and approvals for Change Requests (CRs) and documentation, along with providing QA presence and process confirmations on the shop floor.

Schedule: Monday to Thursday, 10-hour day shift.

Key Responsibilities:

Compliance and Documentation:

Ensure site compliance with regulations, ISO standards, and corporate/local SOPs.
Review and approve documentation for Quality, including batch records and other relevant materials.
Support and review investigations and root cause analysis.

Process Support and Safety:

Participate in process confirmations and Go Look Sees.
Adhere to all safety and environmental requirements in performing duties.
Other assigned accountabilities as needed.

Physical Requirements:

Ability to move equipment/supplies weighing up to 33 pounds within the facility.
May require standing for up to a 12-hour shift.
Requires corrected vision to 20/20 or 20/25 (based on role) and color vision (based on role).
Must be able to work in noisy environments with hearing protection.

Qualifications:

Education:
- Bachelor’s degree in life sciences or a related field from an accredited university required.
- Equivalent combinations of education and internal Novo Nordisk business/operational experience may substitute for a degree.
Experience:
- Minimum of one (1) year of QA and/or cGMP-related experience, preferably in the pharmaceutical or medical device industry.
- General knowledge of Batch Review Processes (BRP), validation processes, and Quality Management Systems (QMS) preferred.
- Experience with quality oversight and on-floor production support preferred.
Skills:
- Good written and verbal communication skills.
- Basic computer skills (MS Office, PowerPoint, Word, Excel).
- Knowledge of cGMPs in manufacturing, especially in pharmaceutical manufacturing.
- Strong knowledge of Quality and Production processes.
- Ability to set goals, prioritize tasks, meet deadlines, and multitask effectively.
- Ability to adjust priorities based on changing circumstances.

Equal Opportunity Employer:

Novo Nordisk is an equal opportunity employer, providing 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 law.

Special Assistance:

If you require special assistance or accommodations to apply, please contact 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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