Senior QA Validation & Batch Release Specialist

Novo Nordisk; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

401K company match

Paid time off

Job summary

Novo Nordisk in Clayton, NC seeks a Quality Assurance professional to oversee production activities and validation, ensuring compliance with regulatory and corporate standards. You will review batch reports, releases, deviations, and change controls while maintaining on-floor QA presence and process improvements.

You will collaborate with cross-functional teams to ensure quality requirements are communicated and met, and you will support root-cause analysis and documentation across systems like

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related field.
• Minimum of five (5) years of experience within the pharmaceutical industry.
• Good Knowledge of cGMP manufacturing & production processes & how to apply required
• Good Knowledge of the Batch review Processes required
• Good Knowledge of quality management systems required
• Good Knowledge of quality oversight & on floor production support required
• Strong knowledge level in cGMP's & validation required
• Strong knowledge in Quality Management Systems required
• Must be ability to perform tasks independently, accurately & within defined time frames required
• Ability to willingly work with customers/stakeholders in a cooperative manner required
• Strong written & verbal communication skills required
• Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
• Proven expertise in planning & organizing tasks preferred
• Willingness to assist others in developing plans in a cross-functional environment preferred
• Innovative approach to establishing priorities preferred

Responsibilities

• Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
• Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers’ ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
• Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
• Support evaluation of the quality level during the project by performing spot checks of validation documentation
• Perform activities related to Batch review & release
• Review & approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
• Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
• Review & approve change control requests
• Review & approve deviations
• guidance to departments regarding quality & related activities
• Participate & provide input to root-cause analysis
• Participate in process confirmations & quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned.

Skills

Pharmaceutical industry experience

cGMP knowledge

Quality management systems

On-floor production support

Strong communication skills

Education

Bachelor's Degree in Life Sciences, Engineering, or related field

Tools

MS Office

Excel

PowerPoint

Word

Job description

Novo Nordisk in Clayton, NC seeks a Quality Assurance professional to oversee production activities and validation, ensuring compliance with regulatory and corporate standards. You will review batch reports, releases, deviations, and change controls while maintaining on-floor QA presence and process improvements.

You will collaborate with cross-functional teams to ensure quality requirements are communicated and met, and you will support root-cause analysis and documentation across systems like