Department: Azzur Consulting LLC
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with the level of incoming experience.
- Development of project plans, as appropriate
- Development and execution of validation test procedures on facilities, utilities, systems, and equipment used to manufacture biotech products (experience with any of the listed examples is a plus)
- Example facilities include warehouse, clean rooms, controlled noncritical rooms and laboratories.
- Example utilities include LN2, electrical, purified water, and HVAC
- Example systems include LIMS, CMMS, change control, EDMS, and CAPA
- Example equipment includes lab scale instrumentation such as centrifuges, PCR, Sepax, controlled temperature units as well as bio-reactors, tanks. Vessels and master cell banks
- Development and editing of SOPs
- Assemble Turn Over Packages
- Coordinate Vendors
- Data Analysis
- Deviation resolution and investigations
- Technical report writing.
- Technical presentations
- BS in Engineering, Science or equivalent technical degree.
- 3-5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills. ∙Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast-paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients throughout the region.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.
With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.
Do What You Love
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Willing to work hands on with multiple clients throughout Southern California
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Perks of Working at Azzur
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ