Sterility Assurance Specialist I at WuXi AppTec

Responsible for producing documents for sterility assurance related programs, providing aseptic processing oversight, and technical support to manufacturing operations to ensure contamination control. Acts as the Primary Sterility Assurance Representative and effectively collaborates with multi-disciplinary teams for designated projects.

Position Details:

Monday to Friday Standard Business Hours

100% Onsite at our Philadelphia, PA location

• Authors and reviews qualifications such as environmental monitoring performance qualification (EMPQs), aseptic process validations (APVs), and airflow visualization (smoke studies).
• Owns change control tasks associated with qualification or program revisions
• Authors risk assessments in support of microbial control strategy and sterility assurance programs
• Performs aseptic processing training for manufacturing and support personnel
• Participates in continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance
• Performs regular GEMBA style assessments of the aseptic process on site to assess compliance of operations including identification of deficiencies and provide real time coaching to aseptic staff
• Authors new and revised procedures for Sterility Assurance department.
• Data approval in EMDS system
• Coordinates with Project teams in design, set up and execution of projects
• Maintains current regulatory knowledge, staying up to date with best practices and sharing knowledge
• Participates in business excellence projects within SA and across site
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends

• Bachelor’s degree with a major in Biology, Microbiology or related Life Science
• 3-5 years relevant technical experience

Knowledge / Skills / Abilities:
• Knowledge of GLP and cGMP guidelines is required.
• Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
• Ability to evaluate technical data and write technical documents.
• Ability to use judgment as dictated by complexity of situation.
• Ability to work under limited supervision and to handle problems of a difficult nature.
• Ability to accomplish the described duties through the use of appropriate equipment and software.
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Ability to record data accurately and legibly.
• Ability to understand and follow verbal or demonstrated instructions.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)

Our Values:

Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

WuXi AppTec 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.