QA Area Specialist I - SDF (2nd shift)

Novo Nordisk A/S; 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

401K contribution plus company match

Tuition Assistance

Job summary

Novo Nordisk A/S in Durham, North Carolina seeks a Quality Assurance professional to ensure compliance with regulations and internal standards. The role involves documentation review, root cause analysis, and participation in audits.

Candidates should have at least two years of experience in Quality Assurance and familiarity with pharmaceutical regulations. A degree in a related field is required. Novo Nordisk offers competitive pay and comprehensive employee benefits, including health insurance and generous paid time off.

Qualifications

• Minimum of two years QA or related quality experience, preferably in the pharmaceutical industry.
• General knowledge of quality systems and production processes preferred.

Responsibilities

• Ensure site compliance with regulations and SOPs.
• Review and approve documentation for Quality approval.
• Support investigations and root-cause analysis.
• Participate in audits and support audit management.

Skills

Basic computer skills in MS Office, MS Project, PowerPoint

Knowledge of pharmaceutical regulations & quality systems

Quality Experience

Education

Associate’s degree in life sciences or related field

Bachelor’s degree

High School Diploma or GED with experience

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

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, Quality Assurance.

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 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
• 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.

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.