Abzena · 3 months ago
QA Associate I/II, Operations
San Diego, CA
Full-time
Onsite
Entry Level
$60K/yr - $75K/yr
1+ years expAbzena is a dedicated partner in the development and manufacturing of biologics and bioconjugates, ensuring quality excellence throughout the process. The Quality Assurance Associate I/II will support quality oversight activities and ensure compliance with regulations, while collaborating with staff and performing batch record reviews and quality assurance tasks.
BiopharmaBiotechnologyLife SciencePharmaceutical
Responsibilities
Provide hands-on QA collaboration and oversight to staff, ensuring compliance to good documentation practices, data integrity compliance, site inspection readiness SOPs, and relevant Good Regulated Practice (GxP) requirements
Work on the floor during production and help make quality decisions to ensure compliance with procedures and regulations
Perform Raw material sampling and release of utilities as and when needed by QA Raw Material team
Perform regular area walkthroughs of the manufacturing and Quality Control areas
Author minor deviations for topics that pertain to Quality Assurance Operations
Author Standard Operating Procedures (SOPs) for topics that pertain to Quality Assurance Operations
Perform batch record review for buffer / media, upstream and downstream manufacturing batch records
Perform disposition of buffer/media solutions manufactured at Abzena
Review and approve manufacturing deviations (minor), CAPAs, change controls and Standard Operating Procedures (SOPs)
Support other departments as required to fulfill business needs
Comply with Abzena's policies and procedures
Communicate effectively with supervisors and colleagues
Participate effectively as a team player in all aspects of Abzena's business
Adhere to quality standards set by regulations and Abzena policies, procedures, and mission
Qualification
Required
Minimum of B.S. degree in Life Sciences or Engineering
2 years of experience in a GMP regulated Biopharmaceutical facility or equivalent
1-3 years of experience in a Quality Assurance-related function
Experience overseeing manufacturing operations, batch record review and quality record
Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial
Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance
Ability to work in a cross-functional environment and resilience to a fast-paced environment
Ability to stand for 3-4 hours at a time and sit for 2 to 3 hours at a time
Frequently lift and or move objects up to 30 pounds
Stand/walk during the entire length of shift
Use arms, hands, and fingers to handle, feel or reach
Ability to climb, balance, stoop, kneel, crouch, or crawl
Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus
Company
Abzena
Abzena is a biotechnology company that offers biologic and ADC products from concept to clinic.
501-1000 employees
H1B Sponsorship
Abzena has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$139.44MKey Investors
Biospring PartnersProVen VCT
2022-03-31Private Equity· $65M
2020-07-28Private Equity· $10M
2018-08-16Acquired
Leadership Team
Geoffrey Glass
Chief Executive Officer
Daniel Giroux
Vice President, Development
Recent News
Genetic Engineering News
2025-11-08
2025-10-24
Company data provided by crunchbase