Novo Nordisk QA Job Opening 2020 – Apply Online
Novo Nordisk QA Job Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our haemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do.
Job Title: Quality Assurance Area Specialist Active Pharmaceutical Ingredient
Location: Clayton, NC, US
Required 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 Qualifications for Novo Nordisk QA Job
- 4 years of QA and/or Validation related experience in the pharmaceutical or medical device industry with progressively increasing responsibility
- General knowledge in Current Good Manufacturing Practice (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 invalidation (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 & Quality Control (QC) Support &/or API Production processes
- Novo Nordisk QA Job 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 the framework
- Solid structural & follow up skills
Physical & Other Requirements
Novo Nordisk QA Job
- Able to work in & around an active construction site
- Able to move throughout the facility to perform duties in close proximity to processing 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%
- No relocation will be offered for this position
Position Purpose
Novo Nordisk QA Job
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, Standard Operating Procedures (SOPs), Training Material, Laboratory Investigations, Trend Reports, Supplier Management, Self-Audits (in conjunction with Line of Business (LoB)), Quality Assurance (QA) presence & process confirmation on shop floor & improvement of Quality processes.
Accountabilities
Novo Nordisk QA Job
- 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
- Novo Nordisk QA Job 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
