Senior QA: Validation & Batch Release Specialist

BioSpace; Clayton (NC); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Leading pay and annual performance, a

14 paid holidays

Health Insurance, Dental Insurance, &

8% 401K contribution

14 weeks paid parental leave

6 weeks paid family medical leave

Free access to Novo Nordisk products

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk in Clayton, NC is seeking an experienced QA professional responsible for production activities and validation, ensuring compliance with health authorities and site procedures.

You will review batch reports, release API materials, handle deviations, change controls, and support quality processes on the shop floor. Strong knowledge of cGMP, validation, and quality management systems is required to succeed.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• Minimum of five (5) years in the pharmaceutical industry.
• Strong knowledge of cGMP manufacturing & production processes.
• Strong knowledge of Batch review processes.
• Strong knowledge of quality management systems.
• Strong knowledge of quality oversight & on-floor production support.
• Strong knowledge of cGMPs & validation.
• Strong knowledge of Quality Management Systems.
• Ability to work independently, accurately & meet deadlines.
• Ability to collaborate with customers and stakeholders.

Responsibilities

• Review batch reports and release API materials.
• Investigate deviations and manage change controls.
• Review and approve SOPs and quality documentation.
• Provide QA presence and process confirmations on the shop floor.
• Support quality processes and continuous improvement initiatives.
• Review and approve API/Intermediate batch documentation in systems (LIMS, SAP).
• Ensure site compliance with regulations, ISO standards and SOPs.
• Participate in root-cause analysis and quality oversight.

Skills

Pharma industry experience

cGMP knowledge

Batch review processes

Quality management systems

Quality oversight & on-floor support

cGMPs & validation

Independent & accurate work

Stakeholder collaboration

MS Office proficiency

Planning & organizing

Education

Bachelor's degree in Life Sciences or related field

Job description

Novo Nordisk in Clayton, NC is seeking an experienced QA professional responsible for production activities and validation, ensuring compliance with health authorities and site procedures.

You will review batch reports, release API materials, handle deviations, change controls, and support quality processes on the shop floor. Strong knowledge of cGMP, validation, and quality management systems is required to succeed.