Quality Assurance Associate III

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY 

Responsible for administration of Quality Operations Activities associated with material management and release, lot disposition, and in-plant QA in compliance with applicable regulatory guidelines and requirements.  

ESSENTIAL JOB DUTIES/RESPONSIBILITIES 

• Review and approve controlled documents including analytical assays, Standard Operating Procedures, Manufacturing Batch Records, and Validation protocols and reports.  

• Review material release documentation and disposition materials for use in cGMP manufacture.   

• Review QC data generated from manufactured product and intermediates and stability testing and approve results summaries.  

• Review and approve simple Change Requests, simple deviations and corresponding CAPA.  

• Support in-plant operations by conducting in-plant review of batch records and providing QA support for operations.  

• Review executed manufacturing batch records for completeness, compliance, and accuracy and partner with others for corrections as necessary.   

• Create and review documents to be included in DHRs.  

• Review and approve equipment onboarding and preventative maintenance and repair work orders.   

• Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes.  

• Supports or may lead multiple more complex projects/initiatives/work items under broad supervision.  

• Analyzes issues and makes decisions based on standardized processes and procedures under close supervision.  

• Communicates moderately complex concepts and interacts with others to inform and direct action.  

• Acts as a resource for less experienced team members and colleagues.  

LEADERSHIP SKILLS 

• Analyzes multiple sources of information and evaluates several alternative solutions before confirming correct path.  

• Explains complicated information and effectively lays out variations of alternatives to consider.  

• Works across teams effectively.  

• Applies understanding of how the team relates to other closely related areas to improve efficiency of own team.  

QUALIFICATIONS  

Required: 

• BS/BA degree and 5+ years of relevant experience.  Equivalent education and experience may substitute for stated requirements.  

 SCHEDULE - MONDAY TO FRIDAY 08 am to 5 pm

COMPENSATION   $74.960 to $ 103.070

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of s