Sterility Assurance Specialist I

1 day ago

Philadelphia, Pennsylvania, United States WuXi AppTec Full time
About the Role

We are seeking a highly skilled Sterility Assurance Specialist I to join our team at WuXi AppTec. As a key member of our Sterility Assurance department, you will be responsible for ensuring the highest standards of sterility and contamination control in our manufacturing operations.

Key Responsibilities
  • Document Development: Author and review qualifications such as environmental monitoring performance qualification (EMPQs), aseptic process validations (APVs), and airflow visualization (smoke studies) to ensure compliance with regulatory requirements.
  • Change Control: Own change control tasks associated with qualification or program revisions, ensuring seamless implementation and minimal disruption to operations.
  • Risk Assessment: Author risk assessments in support of microbial control strategy and sterility assurance programs, identifying potential risks and implementing mitigation measures.
  • Aseptic Processing Training: Provide aseptic processing training for manufacturing and support personnel, ensuring they have the necessary skills and knowledge to perform their roles effectively.
  • Continuous Improvement: Participate in continuous improvement initiatives and implement best practices to ensure understanding and compliance with SA-related regulations and guidance.
  • GEMBA Assessments: Perform regular GEMBA-style assessments of the aseptic process on site to assess compliance of operations, identify deficiencies, and provide real-time coaching to aseptic staff.
  • Procedure Development: Author new and revised procedures for the Sterility Assurance department, ensuring they are accurate, comprehensive, and up-to-date.
  • Data Management: Approve data in the EMDS system, ensuring accuracy and completeness.
  • Project Coordination: Coordinate with project teams in design, setup, and execution of projects, ensuring timely completion and effective collaboration.
  • Regulatory Knowledge: Maintain current regulatory knowledge, staying up-to-date with best practices and sharing knowledge with the team.
  • Business Excellence: Participate in business excellence projects within SA and across the site, driving continuous improvement and excellence.
  • Teamwork: Ability to work in a team environment and independently as required, with a strong focus on collaboration and communication.
Requirements
  • Education: Bachelor's degree with a major in Biology, Microbiology, or a related Life Science.
  • Experience: 3-5 years of relevant technical experience in a similar role.
  • Skills: Knowledge of GLP and cGMP guidelines, ability to make decisions based on advanced or technical concepts, evaluate technical data, and write technical documents.
  • Software: Proficient in Microsoft (Excel, Word, Outlook).
  • Language: Proficient in oral and written communication skills, with the ability to read, write, and understand English.
About WuXi AppTec

We are a global contract research organization (CRO) that provides a comprehensive range of services to support the discovery, development, and manufacture of pharmaceuticals and biologics. Our values include Integrity & Dedication, Working Together & Sharing Success, and Doing the Right Thing & Doing it Right.

We are committed to providing opportunities for internal growth and development, with direct access to a dedicated and accessible Human Resources team. We are an equal employment opportunity employer, dedicated to diversity and inclusion in the workplace.

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