QA Area Specialist I - SDF (2nd shift)

Novo Nordisk; Durham (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Leading pay and annual performance bonus

Generous paid time off including 14 paid holidays

Health, Dental, and Vision Insurance effective day one

Tuition Assistance

Job summary

Novo Nordisk is looking for a Quality Assurance professional based in Durham, North Carolina. The role involves ensuring compliance with regulations, reviewing documentation for quality approval, and supporting investigations in the pharmaceutical industry.

Applicants should possess at least an Associate’s degree in life sciences and have a strong understanding of quality systems and pharmaceutical regulations. This role promises a dynamic work environment with an inclusive recruitment process.

Qualifications

• Minimum of two years QA and/or quality-related experience required.
• Solid understanding of quality systems and pharmaceutical regulations.
• Experience in the pharmaceutical industry preferred.

Responsibilities

• Ensure site compliance with regulations and ISO standards.
• Review and approve documentation for Quality approval.
• Support investigations and root-cause analysis with continuous improvement.

Skills

Written and verbal communication skills

Basic computer skills in MS Office

General knowledge of pharmaceutical regulations

Experience in QA or related quality

Education

Associate’s degree in life sciences or related field

Bachelor’s degree in a related field

Tools

MS Office

MS Project

PowerPoint

Job description

Benefits

• 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

Responsibilities

Relationships: Reports to Manager, Quality Assurance.

• 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 color 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.

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.