QA Associate I/II, Operations at Abzena

The Quality Assurance Associate I/II, Quality Operations will ensure the site performs in a state of compliance by supporting Quality oversight activities and fostering an empowered culture of quality across manufacturing processes.The Associate will support on the floor activities, perform batch record review of buffer/medias/process records, support Deviations/ Change Controls / CAPAs and support quality workstreams as required. 



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.  

Qualifications

Minimum of B.S. degree in Life Sciences or Engineering with ≥ 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. 

Physical Requirements

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.  

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