Overview
Quality Inspector II-2nd Shift Jobs in Mesa, AZ at Mitsubishi Chemical Advanced Materials
QED Remote – United States Quality Assurance
About QED Therapeutics & BridgeBio Pharma
QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
Our business is inspired by our values:
PUT PATIENTS FIRST
LET SCIENCE SPEAK
EVERY MINUTE COUNTS
THINK INDEPENDENTLY
BE RADICALLY TRANSPARENT
FGFR=fibroblast growth factor receptor.
BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.
Who You Are
Reporting to the Associate Director, Quality Assurance, the Senior Manager, Quality Assurance will assist in the quality oversight and management of internal and external GxP Quality Systems and processes including, but not limited to: Document Control, Training, and Quality Metrics. The ideal candidate will have quality assurance experience working in the biotech/pharmaceutical sector.
Responsibilities
Management of QED Training, including onboarding, curricula, learner roles, training matrices, and annual GxP training
Develop and deliver training on GXP SOPs and systems
Support management and maintenance of quality systems such as Document Control, Change Control, Deviations, CAPA, and Effectiveness Checks
Author and implement QA GXP standard operating procedures (SOPs)
Assists in the management, maintenance, and evaluation of QED’s Quality Management Systems and processes for optimization and continuous improvement
Assist in the development and preparation of GxP metric reports and dashboards
Ability to effectively multi-task to meet deadlines and commitments
Assist in inspection readiness activities for GXP activities at QED
Other duties as assigned or required
No matter your role at BridgeBio, successful team members are:
Patient Champions, who put patients first and uphold strict ethical standards
Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
Truth Seekers, who are detailed, rational, and humble problem solvers
Individuals Who Inspire Excellence in themselves and those around them
High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills Requirements
Bachelor’s degree in a scientific discipline or equivalent experience
Minimum of 7 years of pharmaceutical industry experience in Quality Assurance or other relevant roles
Knowledge of applicable GXP regulations (e.g., CFRs and ICH)
Extensive knowledge of Veeva Quality Docs and Veeva Training modules
Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
Attention to detail and proper use of tools for information processing and electronic systems
Other skills and abilities as required
What We Offer
Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
An unyielding commitment to always putting patients first.
A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
A place where you own the vision – both for your program and your own career path
A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
Access to learning and development resources to help you get in the best professional shape of your life
Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
Flexible PTO
Rapid career advancement for strong performers
Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
Partnerships with leading institutions
Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$130,000—$180,000 USD
Title: Quality Inspector II-2nd Shift
Company: Mitsubishi Chemical Advanced Materials
Location: Mesa, AZ
