QA Batch Release Specialist II
Biopharma Careers
A complete application in a minute — tailored resume and cover letter, ready to send.
Benefits offered by this job
Job summary
Novo Nordisk in Clayton, NC seeks an experienced QA professional to review batch reports and support API material release. You will verify deviations, approve SOPs and minor changes, and ensure shop-floor QA presence for process improvements.
Ideal candidates have a life sciences or engineering degree and at least 3 years in pharmaceutical QA, with strong cGMP knowledge and excellent communication skills. On-site role with comprehensive benefits.
Qualifications
- Bachelor's degree in life sciences, engineering or related field, or equivalent.
- Minimum of three years' QA or related experience in pharma/medical devices.
- Strong knowledge of cGMP manufacturing and production processes.
- Experience with batch review processes and quality oversight on the floor.
- Excellent written and verbal communication; strong MS Office skills.
Responsibilities
- Review batch reports for API material release and deviations.
- Review and approve SOPs and minor change controls.
- Support QA on the shop floor and drive quality process improvements.
- Review API/intermediate batch docs in LIMs, SAP, NovoGlow, etc.
- Participate in root-cause analysis and process confirmations.
Skills
Education
Tools
Job description
Novo Nordisk in Clayton, NC seeks an experienced QA professional to review batch reports and support API material release. You will verify deviations, approve SOPs and minor changes, and ensure shop-floor QA presence for process improvements.
Ideal candidates have a life sciences or engineering degree and at least 3 years in pharmaceutical QA, with strong cGMP knowledge and excellent communication skills. On-site role with comprehensive benefits.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
