Current jobs related to Sterility Assurance Specialist I - Philadelphia PA - WuXi AppTec

  • Sterility Assurance Specialist I

    2 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWuXi AppTec is seeking a highly skilled Sterility Assurance Specialist I to join our team. The successful candidate will be responsible for producing documents for sterility assurance related programs, providing aseptic processing oversight, and technical support to manufacturing operations to ensure contamination control.As the Primary Sterility...

  • Sterility Assurance Specialist I

    2 months ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    About the RoleWe 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 ResponsibilitiesDocument Development: Author and review...

  • Sterility Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job Title: Sterility Assurance Specialist IWuXi AppTec is seeking a highly skilled Sterility Assurance Specialist I to join our team. As a key member of our Sterility Assurance department, you will be responsible for ensuring the highest level of sterility assurance in our manufacturing operations.Key Responsibilities:Author and review qualifications such as...

  • Sterility Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Actalent Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at Actalent. The successful candidate will be responsible for ensuring the highest standards of sterility and asepsis in our manufacturing processes.Key ResponsibilitiesDevelop and implement sterility assurance principles and protocolsConduct environmental monitoring...

  • Sterility Assurance Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...

  • Sterility Assurance Specialist

    1 month ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our quality assurance team, you will be responsible for ensuring the sterility and quality of our products.Key ResponsibilitiesDevelop and implement sterility assurance programs to ensure compliance with regulatory...

  • Sterility Assurance Specialist I

    2 months ago

    Philadelphia/PA/US WuXi AppTec Full time

    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...

  • Sterility Assurance Specialist I

    2 months ago

    Philadelphia/PA/US WuXi AppTec Full time

    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...

  • Sterility Assurance Specialist

    2 months ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...

  • Sterility Assurance Specialist

    2 months ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...

  • Sterility Assurance Specialist

    2 months ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist to join our team at WuXi AppTec. As a key member of our Data Operations department, you will be responsible for ensuring the highest standards of sterility assurance in our manufacturing operations.Key ResponsibilitiesDevelop and implement sterility assurance programs, including...

  • Sterility Assurance Specialist I

    2 months ago

    Philadelphia, United States WuXi AppTec Full time

    Job DescriptionResponsible 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...

  • Sterility Assurance Specialist

    2 months ago

    Philadelphia, Pennsylvania, United States WuXi AppTec Full time

    Job SummaryWe are seeking a highly skilled Sterility Assurance Specialist 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 contamination control and sterility assurance in our manufacturing operations.Key ResponsibilitiesAuthor and review qualifications such...

  • Sterility Assurance Specialist I

    2 months ago

    Philadelphia, United States WuXi AppTec Full time

    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...

  • Sterility Assurance Specialist I

    2 months ago

    Philadelphia, United States WuXi AppTec Full time

    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...

  • Sterility Assurance Specialist I

    1 month ago

    Philadelphia, United States WuXi AppTec Full time

    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...

  • Sterile Processing Educator and Quality Assurance Specialist

    3 weeks ago

    Philadelphia, Pennsylvania, United States Jefferson Health Full time

    Job SummaryWe are seeking a highly skilled Sterile Processing Educator and Quality Assurance Coordinator to join our team at Jefferson Health. This individual will be responsible for planning, implementing, and appraising orientation, competency, and quality assurance programs for Sterile Processing Department personnel.Key ResponsibilitiesDevelop and...

  • Quality Control Specialist II, Sterility Assurance

    3 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title: Quality Control Specialist II, Sterility AssuranceWe are seeking a highly skilled Quality Control Specialist II, Sterility Assurance to join our team at Planet Pharma. This role will be responsible for ensuring the harmonized execution of contamination control policies across our manufacturing sites.Key Responsibilities:Collaborate with...

  • Quality Control Specialist Sterility Assurance

    3 weeks ago

    Philadelphia, Pennsylvania, United States Iovance Biotherapeutics, Inc. Full time

    Job Title: Quality Control Specialist Sterility AssuranceJob Summary:The Quality Control Specialist Sterility Assurance will be responsible for ensuring the harmonized execution of contamination control policies across our manufacturing sites. This role will also support new product transfers related to contamination control aspects of manufacturing process...

  • Quality Control Specialist II, Sterility Assurance

    4 weeks ago

    Philadelphia, United States Planet Pharma Full time

    615203 Quality Control Specialist II, Sterility AssuranceDirect HirePhiladelphia, PAMicrobiology experienceGood Aseptic gowning background/experienceContamination experienceManufacturing/GMP experienceOverview The Quality Control Specialist, Sterility Assurance is responsible for effectively collaborating with multiple stakeholders to ensure the harmonized...

Sterility Assurance Specialist I

2 months ago

Philadelphia PA, United States WuXi AppTec Full time

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.