Department: Azzur Labs, LLC
Azzur Lab is looking for a highly motivated Senior Associate Scientist to manage the QC groups and oversee daily lab operations of all associated support functions. This is an exciting new position in a well-established life sciences company, helping to expand new lab functions and capabilities, supporting clients at various phases of life-saving drug development. Reporting to the Head of Laboratory Services, the successful applicant will be operationally-minded, organize multiple efforts, and be comfortable supporting several dynamic and diverse groups within the department.
Duties and Responsibilities:
The Senior Quality Control Laboratory Manager performs the following tasks:
- Oversee the daily activities of the laboratory to ensure that all microbiology, chemical, potency, and biochemical testing is performed.
- Coordinate and conduct, when needed, testing and wet-lab work of final drug products following GxP (including GLP and data integrity) compliance.
- Oversee the laboratory quality assurance program to include specimen collection, handling, reporting, quality control, documentation review, and proficiency testing.
- Develop, draft, or revise all applicable technical documents as appropriate.
- Verify testing, data analysis, and testing results are accurate and meet requirements with company policies, GDP, and data integrity.
- Assure all the non-conforming test results and QC related deviations are timely investigated in accordance with quality/regulatory compliance.
- Ensure appropriate training and development plans are in place for all QC employees.
- Manage, stock, and order all common inventory of lab consumables, reagents, buffers, liquid nitrogen, and CO2
- Receive sample shipment and ship out to internal and external stakeholders.
- Proactively identify and implement tools and processes to enhance operational and planning efficiencies.
- Optimize productivity and capitalize QC resources (staff, equipment, systems, and space) to meet the operational/business needs.
- Establish quality measures and identify ways to improve efficiency and cost.
- Hire, provide training for, and evaluate the necessary qualified laboratory staff to adequately perform general and specific lab procedures.
- Participate in Sponsor audits and site visits.
- Assist QA in performing and managing deviations, out-of-specification. investigations, out-of-trend observations, corrective and preventive action (CAPA) plans, and change controls.
- Appropriate CAPAs are to be timely implemented to prevent recurrences.
- Collaborate closely and timely with internal and external stakeholders to support the associated lab functions of the entire assignment or project.
Qualifications and preferred experience:
- Possesses a bachelor’s degree in life sciences or higher.
- 5 – 7 years of relevant industry experience with 5+ years of managing a QC laboratory, and 4 – 5 years of experience in people management.
- Familiar with different analytical instruments such as flow cytometers, multi-mode plate readers, stemVision™, MSD, ProteinSimple units, and using 3rd party data analysis software.
- Knowledge and experience with qualifying and validating QC methods
- Skills in addition to bioassays including ddPCR, qPCR, ELISA, flow cytometry, and western blot.
- Ability to manage, multi-task, delegate, and retain flexibility in a dynamic setting.
- In-depth knowledge of GxP and ICH compliance relevant to a GMP QC lab operation.
- Well-developed written and oral communication skills. Motivated to work in a team environment.
- Excellent attention to detail and exceptional organizational and planning skills.
- Good troubleshooting and conflict resolution skills.
- A self-starter and a great communicator with a keen sense of execution and collaboration.
- Champion, lead, and participate in continuous improvement activities within the facility.
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.
- 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
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 our customers.
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!