Sterility Assurance Quality Associate

7 days ago


Suzhou, Jiangsu, China Lilly Full time

We are seeking dedicated individuals who are committed to enhancing the quality of life for people globally.

This position involves serving as the area Quality Assurance representative for the Sterility Assurance and Environmental Monitoring teams, ensuring that the sterility assurance initiatives comply with regulatory standards.

Key Responsibilities

  • Regulatory Compliance: Ensure that sterility assurance programs align with regulatory agency guidelines and meet Lilly's global quality standards.
  • Documentation Review: Analyze updates from Pharmacopeia and regulatory documents pertinent to sterility assurance for drug registration support.
  • Quality Representation: Act as a quality representative within the integrated sterility assurance team, possessing a thorough understanding of the scientific principles behind aseptic manufacturing processes.
  • Audit Participation: Engage in internal and external audits, providing support for inspection responses and offering recommendations.
  • Team Collaboration: Foster an open communication environment to enhance teamwork and encourage collaboration across departments.
  • Network Development: Strengthen relationships with Lilly Global and local pharmaceutical companies to enhance the sterility assurance network.
  • Safety Improvement: Actively participate in safety initiatives to promote ongoing improvements in safety standards.
  • Document Approval: Review and approve strategy documents, procedures, and reports related to sterility assurance and validation.
  • Change Management: Oversee investigations of changes and non-conformances in sterility assurance, ensuring compliance and effectiveness of corrective actions.
  • Risk Management: Utilize quality risk management techniques to evaluate manufacturing processes for parenteral products and their contamination controls.
  • Quality Oversight: Collaborate with teams to provide quality oversight for sterility assurance and validation projects.
  • Expert Participation: Serve as a subject matter expert in quality assurance during aseptic checks and high-risk interventions.

Basic Qualifications:

  • Bachelor's degree or higher in biology, microbiology, pharmaceutical sciences, or a related field.
  • Understanding of Good Manufacturing Practices (GMP) and applicable internal standards.
  • Ability to work standard hours with potential for overtime.
  • Minimal travel may be required.
  • Adherence to Health, Safety, and Environmental (HSE) procedures.

Additional Skills:

  • Proficient in technical writing and presentation skills.
  • Strong written and verbal communication skills in English.
  • Excellent teamwork and interpersonal abilities.
  • Competent computer skills.

Additional Information:

Applicants will work in various areas within the manufacturing site, where some allergens may be present. Lilly is an equal opportunity employer, ensuring no discrimination based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

#WeAreLilly



  • Suzhou, Jiangsu, China Lilly Full time

    We are seeking dedicated individuals committed to enhancing global health. This position serves as the Quality Assurance representative for the Sterility Assurance and Environmental Monitoring teams, ensuring compliance with regulatory standards. Key Responsibilities Ensure that Sterility Assurance initiatives align with regulatory requirements and...

  • QA Specialist

    7 days ago


    Suzhou, Jiangsu, China Lilly Full time

    We are seeking dedicated individuals who are committed to enhancing the quality of life for people globally. This position serves as the area Quality Assurance representative for the Sterility Assurance and Environmental Monitoring teams, ensuring that the sterility assurance initiatives comply with regulatory standards. Key Responsibilities: Regulatory...


  • Suzhou, Jiangsu, China Bosch Full time

    Job OverviewAs a Quality Assurance Engineer at Bosch, you will play a critical role in ensuring the quality of our products and processes. Your primary responsibility will be to oversee the claims processing in the plant, including recording, evaluation, and conclusion of all claims.Key ResponsibilitiesProcess owner for claims processing: Record, evaluate,...


  • Suzhou, Jiangsu, China Bosch Full time

    Job OverviewAs a Quality Assurance Engineer at Bosch, you will play a critical role in ensuring the quality of our products and processes. Your primary responsibility will be to oversee the claims processing in the plant, including recording, evaluation, and conclusion of all claims.Key ResponsibilitiesProcess owner for claims processing: Record, evaluate,...


  • Suzhou, Jiangsu, China Bosch Group Full time

    Job Description• Process Owner for Claims Processing: responsible for recording, evaluating, and concluding all claims in the plant.• Short-Term Delivery Security: ensure the secure delivery of production in the event of a claim. Suggest required measures, agree them with the specialist department, supervise, and document (e.g. reworking, termination of...


  • Suzhou, Jiangsu, China Danaher Full time

    Job Summary:We are seeking a Quality Assurance Engineer (Instrumentation) to join our team at Danaher. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our instrumentation products.Main Responsibilities:Develop and implement quality assurance procedures and protocols to ensure compliance with regulatory...


  • Suzhou, Jiangsu, China Timken Full time

    About TimkenAt Timken, we're driven by a passion to make a difference in the world. Our company has a rich history of innovation and excellence, and we're committed to continuing that legacy. We're a global leader in the design, manufacture, and distribution of bearings and power transmission products, and we're proud to be a part of the industrial equipment...


  • Suzhou, Jiangsu, China Danaher Full time

    **Quality Assurance Services**We are seeking a highly skilled Quality Assurance Specialist II to join our team at Danaher. In this role, you will be responsible for:Providing quality assurance services to ensure compliance with regulatory requirements and company standards.Conducting inspection activities to identify and address quality issues.Supporting...


  • Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About UsMaquet (Suzhou) Co, Ltd. is a leading medical device company dedicated to providing innovative solutions for healthcare professionals. Our mission is to improve patient outcomes and enhance the quality of life.Job SummaryWe are seeking a highly motivated and experienced Supplier Quality Assurance Specialist to join our team. The successful candidate...


  • Suzhou, Jiangsu, China Phillips-Medisize Full time

    About Our TeamAt Phillips-Medisize, our team is dedicated to delivering innovative solutions that meet the evolving needs of our customers.Key ResponsibilitiesDevelop and implement quality assurance processes to ensure compliance with regulatory requirements.Collaborate with cross-functional teams to design and develop new products.Analyze and improve...


  • Suzhou, Jiangsu, China Reckitt Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at Reckitt. As a Quality Assurance Manager, you will be responsible for ensuring the highest standards of quality and compliance within our supply and distribution chains.About the RoleThis is an exciting opportunity to join a global team united by a shared purpose: to...


  • Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About UsMaquet (Suzhou) Co, Ltd. is a leading medical technology company dedicated to making life-saving technology accessible for more people. We exist to make a true difference for our customers and to save more lives.Our TeamWe are a diverse team of passionate people who are committed to developing both personally and professionally. We believe in...


  • Suzhou, Jiangsu, China Danaher Full time

    Job Summary:We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Danaher. As a Senior Quality Assurance Engineer, you will be responsible for ensuring the quality of our products and processes, and for implementing and maintaining quality systems and procedures.Key Responsibilities:Develop and implement quality systems and...


  • Suzhou, Jiangsu, China Timken Full time

    About TimkenAt Timken, we're driven by a passion to make a difference in the world. Our company has a rich history of innovation and a commitment to excellence that has enabled us to play a critical role in shaping the world's infrastructure, transportation systems, and industrial equipment.Job SummaryWe're seeking a highly skilled Quality Assurance...


  • Suzhou, Jiangsu, China FICOSA Full time

    Job DescriptionJob Summary:FICOSA is seeking a highly skilled Design Quality Assurance Engineer to join our team. As a key member of our product development team, you will be responsible for ensuring the quality of our products meets the highest standards.Key Responsibilities:Collaborate with cross-functional teams to develop and implement quality assurance...


  • Suzhou, Jiangsu, China Freudenberg Full time

    Overview:At Freudenberg, we are committed to excellence in quality assurance and management.Key Responsibilities:Oversee quality management processes throughout the lifecycle of new product development utilizing methodologies such as APQP, PPAP, P-FMEA, CP, CTQ, QSI, MSA, and SPC.Engage with clients to accurately define quality standards and enhance product...


  • Suzhou, Jiangsu, China Getinge Full time

    With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are...


  • Suzhou, Jiangsu, China Freudenberg Full time

    Overview:As a pivotal member of Freudenberg, you will play a critical role in ensuring product excellence and customer satisfaction.Core Responsibilities:Oversee quality assurance processes throughout the product development lifecycle, utilizing methodologies such as APQP, PPAP, P-FMEA, CP, CTQ, QSI, MSA, and SPC.Engage with clients to accurately establish...


  • Suzhou, Jiangsu, China Freudenberg Full time

    About the Role:As a pivotal member of the quality assurance team at Freudenberg, you will be responsible for ensuring that our products meet the highest standards of quality and performance.Key Responsibilities:Oversee quality management processes throughout the lifecycle of new product development, utilizing methodologies such as APQP, PPAP, P-FMEA, CP,...


  • Suzhou, Jiangsu, China Reckitt Full time

    About the RoleWe are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Reckitt. As a key member of our quality team, you will be responsible for ensuring that all finished products released from our site meet the highest standards of quality and compliance.Key ResponsibilitiesDevelop and implement quality management...