Responsible for providing technical writing support to Sterility Assurance for excursions within a manufacturing GMP facility. Perform root cause analysis to discover the main issue and how it can be resolved.

• Understands aseptic technique concepts
• Able to identify unacceptable practices and implement improvements
• Understands basic operations and functions of equipment
• Understands the maintenance of equipment
• Understands basic solution and material preparation
• Possesses basic technical knowledge and background in the pharmaceutical and
  biotechnology industry
• Possesses basic and fundamental environmental monitoring knowledge and is
  able to apply in the manufacturing area
• Understands the application of GMP concepts and is able to recommend and
  identify improvements of sterility assurance
• Possesses basic and fundamental understanding of material related activities
• Possesses proficiency on Master Control
• Possesses proficiency on Novatek
• Understands the concept of manufacturing processes and methods
• Identifies, understands and able to explain the ‘why’ of acceptable and
  unacceptable practices, is able to make suggestions to improve performance
• Performs basic analysis, interprets, and draws conclusion of scientific and process
  data per good document practices
• Follows compliance and regulatory requirements and current Good Manufacturing
  Practices (cGMPs) and understands ‘why’ behind the regulations.
• Identifies, communicates, addresses and improves simple cGMP compliance and
  regulatory gaps and issues
• Follows and executes Standard Operating Procedures (SOPs)
• Revises, authors and provides comments as a reviewer to simple SOPs
• Improves the efficiency and execution of SOP
• Trains others on basic SOPs, equipment and unit operations
• Participates, provides information in the development of and authors basic technical documents such as non-conforming events, deviations, CAPA’s, action plans and change controls
• Possess basic computer skills and able to efficiently use basic Microsoft applications
• Suggests, participates and implements continuous improvement ideas
• Identifies, participates, suggests solutions and leads basic technical problems
• Identifies, participates, suggests with options, recommends path forward and leads basic decision making
• Participates, supports, presents and represents as an SME during regulatoryinspections and client audits
• Interacts frequently with groups
• Regularly coordinates with groups
• Performs well under minimal supervision and starts to work independently on basic tasks and processes

• High School diploma and over 6 years of relevant experience or
• Associates’/Bachelor’s (science preferred) degree with over 3 years of relevant
  or equivalent experience

Advanced Therapies, LLC provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.