Sterility Assurance Technical Writer II

About the position

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.

Responsibilities

• 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 regulatory inspections 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

Requirements

• 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