Prabhdeep Singh

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QA Area Specialist API Job

Date: Jul 8, 2019

Location: Clayton, NC, US

Company: Novo Nordisk

At Novo Nordisk, we want to make a difference. For more than 95 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Help us bring quality to life. We are currently seeking top talent for our two pharmaceutical manufacturing facilities in Clayton, NC.

Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility

Your Groundbreaking Journey

To help meet the growing demand for our treatments, Novo Nordisk expects to double production of diabetes and obesity drugs over the next decade. We are currently building a new 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC next to our existing “fill and finish” manufacturing facility. Our new $2 billion API facility is expected to be operational in 2020, with 700 full-time employees responsible for the fermentation, recovery and purification of insulin and GLP1 ingredients. This once in a life-time career opportunity is ideal for pharmaceutical manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design, build and validate our processes. Here, you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Position Purpose:

Main duties include review & approval of batch reports for release of API materials & Validation Life Cycle documentation (requirements, planning, protocols & reports). Other duties include review/approval of NCs, Change Requests, SOPs, Training Material, Laboratory Investigations, Trend Reports, Supplier Management, Self Audits (in conjunction with LoB), QA presence & process confirmation on shop floor & improvement of Quality processes.


  • Perform activities related to Batch 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 of validation life documentation including requirements, planning, protocols, test plans, reports & risk assessments.
  • Participate in project teams as the compliance resource.
  • Provide guidance to departments regarding quality & related activities.
  • Support root-cause analysis & review/approve cross-functional investigations.
  • Participate in process confirmations & Go Look Sees.
  • Participate in knowledge & experience sharing to assure collaboration, communication & create results in relation to compliance with company procedures, policies & objectives.
  • Evaluate trend & report data for continuous improvement, QMRs & APR reports.
  • Perform other duties as assigned.

Requires Qualifications:

  • BA/BS degree in Life Sciences, Engineering, or related field.
  • Excellent written & verbal communication skills.
  • Basic computer skills in MS Office, PowerPoint, Word, Excel, etc.

Desired/Preferred Qualifications:

  • 4 years of QA and/or Validation related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
  • General knowledge in cGMP manufacturing & production processes associated with API facilities.
  • General knowledge in Batch Release Processes as related to API production.
  • General knowledge in local processes & quality management systems.
  • Demonstrated expertise in validation (e.g., requirement specifications, IOPQ, reports, etc.).
  • Demonstrated quality management systems (e.g., Product disposition, NC/CAPA, Change Control, Audits & Supplier Management).
  • Provide continuous improvement solutions/feedback.
  • Application of cGMPs in pharmaceutical manufacturing.
  • Knowledge of Quality, Business & QC Support &/or API Production processes.
  • Knowledge of US, EU, & ROW expectations, guidelines & regulations.
  • Knowledge of ASME, ISO, PDA & ISPE standards.
  • Internal auditing experience with certification.
  • Experience in the use of Six Sigma & LEAN tools.
  • Good stakeholder management & change management skills.
  • Strong in setting direction & describing framework.
  • Solid structural & follow up skills.

Physical Requirements:

  • Able to work in & around an active construction site.
  • Able to move throughout the facility to perform duties in close proximity to process equipment & areas.
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation.
  • Able to work in an open office environment with the possibility of frequent distraction.
  • Must be able to travel domestically & internationally, up to 10%.

The sourcing period for this role will end 22 July 2019.

Life-Changing Careers with Novo Nordisk

With a local presence for more than 25 years, Novo Nordisk is one of the largest employers in Johnston County, with over 1,200 highly-skilled and dedicated employees working in Clayton and a diverse, global workforce of more than 40,000.

We aspire to operate in a socially responsible way, and we are committed to offering a healthy and engaging workplace. Our Clayton manufacturing facilities have been honored as a FORTUNE 100 Best Places to Work For 10 years in a row. Other recent employer honors include the ISPE Company of the Year, the Triangle Business Journal Healthiest Employers in the Triangle and the NC Department of Labor 2 Million Hour Safety Award. Approximately 19% of our Clayton employees are veterans, and we offer year-round opportunities to give back to the community. If you’re looking for a life-changing career with real impact, join our team and help us defeat diabetes, obesity and other chronic diseases.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

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.

Requisition ID: 60124BR
State/Provinces: Clayton
Job Category: Quality

Nearest Major Market: Raleigh

Job Segment: Medical, Engineer, ERP, Quality Manager, Special Medicine, Healthcare, Engineering, Technology, Quality