QA Associate I

Aspen is seeking a Quality Assurance Associate I to contribute to general QA operations in support of iPSC/DAN GMP manufacturing. The individual shall work independently and collaboratively under general supervision of the Director of Quality Assurance. This is a terrific opportunity for growing your career in cell therapy QA.

DUTIES AND RESPONSIBILITIES

• Support and/or perform QA and production related activities ensuring products are manufactured in compliance with regulatory and GMP guidelines.
• Ensure timely assessment and closure of discrepancies, deviations, CAPAs, laboratory investigations, and change controls
  

• Perform QA line clearance, walk-throughs, and process observations
• Review and label quarantine/release of raw materials and components for GMP use
  
• Support internal and external audits
  
• Escalate issues that may adversely impact timely release of product
  
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution
  
• Generate and update procedures and forms as needed
  
• Assist in making continuous improvements to the quality systems
  
• May perform other duties and responsibilities as assigned
  

EDUCATION AND EXPERIENCE

• High school diploma and minimum 1 year of experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic, or medical device industries in a Quality Assurance position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc., or bachelor’s degree.
• Experience working in a regulated environment (GMP, GLP) is preferred. Experience applicable to cell therapies is a plus
  
• Experience in aseptic technique, drug safety testing, and environmental monitoring is preferred
  
• Experience in controlled (ISO 5/ISO7) clean room environments is preferred
  

JOB SPECIFICATIONS

• Ability to work a flexible schedule; weekend work will be required during manufacturing campaigns to support process operations.
• Knowledge of regulatory guidelines and requirements (USP/EP compendia, FDA, ISO, GMP, and ICH) applicable to biologics.
  
• Comfortable in a fast-paced, small company environment, and able to adjust workload based on changing priorities.
  
• Some familiarity with 21 CFR Parts 210 & 211, biotechnology, and electronic validated computer systems a plus.
  
• Ability to independently gown for clean room environment.
  
• Demonstrated ability to work independently with minimal instruction.
  
• Must be detail oriented with strong organizational and documentation skills.
  
• Good communication skills.
  
• Proficient in Microsoft Suite Software.
  

EEO and Employment Eligibility 

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.

Total Rewards and Culture 

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks. 

The anticipated pay range for candidates who will work in San Diego is $26.00/hr to $39.00/hr.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.  Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.