QC Regulatory & Stability Area Specialist
Novo Nordisk
11 hours ago
On-site
Durham, NC
Operations
The Position:
Responsible for supporting stability and retain programs for the Quality Control site. Support process and drive improvement activities based on process performance, event response, and process confirmation. Ensure audit readiness and share ideas/solutions with other departments and sites.
Essential Functions:
- Prepare and update stability protocols and reports
- Trend stability data and initiate trend investigations
- Provide stability and retain reports to corporate for annual product reviews
- Track and ensure stability testing is completed on time
- Write stability documents to support regulatory submissions for new products
- Write stability documents for other regulatory requests
- Support LIMS builds and training
- Maintain stability and reference sample inventory (storage and discard)
- Serve as stability representative during audits/inspections
- Participate as a project team member for new product transfers
- Other duties as assigned
Qualifications:
- Bachelor’s Degree in Chemistry or related scientific field (preferred) or equivalent education/experience (required)
- Minimum 2 years of experience with stability programs and/or regulatory-relevant experience (preferred)
- Strong verbal and written communication; ability to author scientific/technical reports (preferred)
- Attention to detail, proofreading, and strong computer skills; willingness to learn new IT applications (preferred)
- Ability to control all aspects of stability and retain programs (plus)
Benefits (explicitly listed):
- Leading pay and annual performance bonus
- Paid time off including 14 paid holidays
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks paid parental and 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance
- Life & Disability insurance
- Employee referral awards
Application instructions (explicitly listed):
- For accommodation requests only: call 1-855-411-5290.
Responsible for supporting stability and retain programs for the Quality Control site. Support process and drive improvement activities based on process performance, event response, and process confirmation. Ensure audit readiness and share ideas/solutions with other departments and sites.
Essential Functions:
- Prepare and update stability protocols and reports
- Trend stability data and initiate trend investigations
- Provide stability and retain reports to corporate for annual product reviews
- Track and ensure stability testing is completed on time
- Write stability documents to support regulatory submissions for new products
- Write stability documents for other regulatory requests
- Support LIMS builds and training
- Maintain stability and reference sample inventory (storage and discard)
- Serve as stability representative during audits/inspections
- Participate as a project team member for new product transfers
- Other duties as assigned
Qualifications:
- Bachelor’s Degree in Chemistry or related scientific field (preferred) or equivalent education/experience (required)
- Minimum 2 years of experience with stability programs and/or regulatory-relevant experience (preferred)
- Strong verbal and written communication; ability to author scientific/technical reports (preferred)
- Attention to detail, proofreading, and strong computer skills; willingness to learn new IT applications (preferred)
- Ability to control all aspects of stability and retain programs (plus)
Benefits (explicitly listed):
- Leading pay and annual performance bonus
- Paid time off including 14 paid holidays
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks paid parental and 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition assistance
- Life & Disability insurance
- Employee referral awards
Application instructions (explicitly listed):
- For accommodation requests only: call 1-855-411-5290.