Department: Azzur Consulting LLC
Azzur Group is looking for QC Validation Specialist to join our growing team. Working with a multi-disciplinary team, the QC Validation Specialist acts as a team member of the Quality Control department to support technology transfer, validation, and/or investigation projects. This role is a Subject Matter Expert for one or more disciplines (Chemistry, Microbiology or Biochemistry). This role writes and reviews test methods, protocols, and reports. Acts as advisor to junior staff to meet schedules and/or resolve technical problems. Provides guidance to junior staff to achieve goals in accordance with established policies. This role applies job skills and company policies and procedures to complete a variety of tasks. Works on assignments that are semi-routine in nature where the ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
Essential Duties and Responsibilities:
- Transitions to a routine tester when needed.
- Act as a team member of the Quality Control department to support technology transfer, validation, and/or investigation projects.
- This role is a Subject Matter Expert for one or more disciplines (Chemistry, Microbiology or Biochemistry).
- This role writes and reviews test methods, protocols, and reports. Acts as advisor to junior staff to meet schedules and/or resolve technical problems.
- Takes personal responsibility for promoting change in his/her area.
- Learns from experience, errors and setbacks.
- Assists QC management on acquiring laboratory supplies and equipment.
- Sets and delivers on individual and team objectives that support the departments goals and strategies.
- Collaborates with other QC teams to drive and complete department goals.
- Works in partnership as an active member of his/her team and cross-functionally
- Actively participates in customer meetings and completes all requests in a timely manner.
- Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time.
- Develops and trains junior QC analysts to ensure consistency across the labs.
- Takes personal accountability for defining and implementing his/her own development and supports others to do same.
- BS in Chemistry, Chemical Engineering or related discipline. MS is preferred.
- Intermediate industry experience, preferably in a cGMP environment
- Intermediate HPLC/ELISA/CE-SDS/icIEF experience.
- Prior experience with method validation, method transfer, and method troubleshooting.
- Proficiency with Laboratory computer systems, such as Empower, MODA, WinkQCL, LIMS, SoftMax Pro, Chemstation and other supporting software.
- Experience with GMP Quality Systems, such as TrackWise, DMS, and LIMS
- Proficiency with Microsoft Suite (Word, Excel, Powerpoint)
- Excellent ability to communicate in both written and verbal format.
- Excellent ability to interpret data.
- Ability to perform assigned, complex and/or varied tasks (ability to make basic quality decisions independently)
- Ability to prioritize and problem solve.
- Ability to direct, control and plan tasks/projects.
- Ability to proactively identify problems/gaps and present ideas for correction,
- Ability to relate to others in a team setting.
- Ability to maintain positive attitude in a team environment.
- Ability to act as an example of professionalism to junior analysts.
- Experience with cooperating on a global team preferred.
- Timeliness in completing assigned tasks.
- Ability to work entire assigned shift, including arriving and departure on time.
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, can 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 everyone 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
- 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