QA Associate 2

Salary Range: 60000 to 80000 (Currency: USD) (Pay period: per-year-salary)

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.