Department: Azzur of North Carolina, LLC
Must be familiar with quality (GMP) and laboratory functions, and documents. Primary responsibilities include generation of facility support document for quality, laboratory, data integrity, and validation of equipment. Candidate must make sound decisions to meet FDA, EU, and product requirements. Make judgments on observations during review and provide resolution. Have a good degree of initiative to identify risks, resolve problems, and discuss, research, and present actions and decisions to be taken before implementing and finalizing a resolution.
- Must have experience with a pharmaceutical GMP environment in one or more of the following disciplines:
- Research & Development, Quality Control, Quality Assurance, Auditor, Investigation and Validation cGMP Compliance.
- Must have thorough knowledge and understanding of regulations or guidelines of cGMPs, GLP, ICH, USP, FDA and pharmaceutical industry guidelines.
- Must have good organizational, presentation, meeting facilitation and technical writing skills.
- Need to be familiar with a Quality Control laboratory environment, regulations, procedures, analysis and understanding of laboratory calculations, conversions, and units.
- Familiarity with 21CFR Part11 and EU Annex 11 compliant electronic Data Acquisition, Equipment Control, and Data Automation Systems is a significant plus
- Ability to utilize Microsoft office tools, Word, Excel, Project, and Data Acquisition System or equivalent to organize and deliver work efficiently.
- Verify accurate transcription of raw data into reports and laboratory documents. Audit above testing for compliance to all applicable SOPs and regulatory requirements.
- Need to be familiar with non-conformity and resolution process.
- Adherence to SOP’s, policies and procedure associated with laboratory functions.
- General: Bachelors’ Degree in Chemistry, Biology, life Science, Engineering, or equivalent with 5+ years’ experience
- Military work/service in related technical disciplines considered
- Software/Automation data & control knowledge a plus
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!