Senior Quality Assurance Engineer Lead

6 hours ago


Indianapolis, Indiana, United States Novartis Group Companies Full time
Job Description

We are seeking an experienced Senior Quality Assurance Engineer Lead to join our team at Novartis Group Companies. As a key member of our quality assurance organization, you will be responsible for providing support to the QA Operations organization for the review and approval of technical QA records.

The successful candidate will have a strong background in validation, maintenance, engineering, or technical quality in a pharmaceutical cGMP or medical device environment. They will be knowledgeable of cGMP procedures and have excellent collaboration and communication skills.

The Senior Quality Assurance Engineer Lead will act as the main contact for technical QA related support for the site, including acting as SME for change controls, reviewing technical QA documents, supporting deviation investigations and CAPA's from a quality perspective, etc. In this role, you will also be a key player for future site expansions.

Key Responsibilities:
  • Provide support to the QA Operations organization for the review and approval of technical QA records.
  • Act as the main contact for technical QA related support for the site.
  • Act as SME for change controls, reviewing technical QA documents, supporting deviation investigations and CAPA's from a quality perspective, etc.
  • Support the creation and review of source documentation intended to be used for regulatory submission.
  • Support the preparation and execution of pre-approval inspection by FDA or any other health authority.
  • Support further expansion of the site with additional manufacturing lines including establishment, review and approval of maintenance and calibration strategy, validation and maintenance protocols, reports and records for the production, warehouse/supply chain and QC departments.
  • Act as single point of contact for QA validation/calibration and maintenance during audits and inspections.
  • Perform QA oversight for validation and qualification activities for specific manufacturing and QC studies.
  • Act as QA investigator to review deviations or OOx related to validation, maintenance, calibration, and technical production related issues.
Requirements:
  • Bachelor's degree in a scientific area. Advanced degree preferred.
  • 5 years of experience in validation, maintenance, engineering or technical quality in a pharmaceutical cGMP or medical device environment.
  • Knowledge of cGMP procedures.
  • Excellent collaboration and communication skills.
  • Very good administrative skills and working knowledge of MS365 and Adobe Acrobat.
Benefits and Rewards:

We offer a competitive salary range of $112,800 to $169,200 per year, as well as a comprehensive benefits package, including medical, financial, and other benefits. We are an equal opportunity employer and welcome applications from diverse candidates.



  • Indianapolis, Indiana, United States Pyramid Technology Solutions Full time

    Job Title: Senior Quality Assurance Engineer Job Summary: We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Pyramid Technology Solutions. As a key member of our quality assurance team, you will be responsible for ensuring the highest quality of our software products. Responsibilities: * Develop and implement efficient...


  • Indianapolis, Indiana, United States Danaher Corporation Full time

    Empowering Scientific DiscoveryAt Danaher Corporation, we are committed to empowering those seeking answers to life's most important scientific and healthcare questions. With a legacy spanning 80 years, we have established ourselves as a trusted partner to our customers, who are working to transform the world through innovative solutions.Join Our MissionWe...


  • Indianapolis, Indiana, United States Novartis Group Companies Full time

    Job DescriptionWe are seeking an experienced Quality Assurance Engineer Lead to join our team at Novartis Group Companies. As a key member of our QA Operations organization, you will provide support for the review and approval of technical QA records, with a focus on the design, construction, commissioning, qualification, and validation of our new lutetium...


  • Indianapolis, Indiana, United States Danaher Corporation Full time

    Job Title: Senior Quality Assurance EngineerWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Beckman Coulter Life Sciences. As a key member of our product development quality team, you will be responsible for ensuring the quality and compliance of our life science products.Key Responsibilities:Represent quality assurance...


  • Indianapolis, Indiana, United States RBW Consulting Full time

    Principal Quality EngineerAs a leading CDMO partner, we are currently seeking a skilled Principal Quality Engineer to take charge of Equipment and Facility design, as well as Commissioning, Qualification, and Procedural Development for large-scale construction projects.This position offers significant potential for long-term stability, professional growth,...


  • Indianapolis, Indiana, United States Pyramid Technology Solutions Full time

    Job DescriptionAs a Senior Quality Assurance Tester at Pyramid Technology Solutions, you will play a crucial role in ensuring the quality of our software products. Your primary responsibility will be to design and execute test plans to identify and report defects in our software applications.Key Responsibilities:Develop and implement efficient testing...


  • Indianapolis, Indiana, United States RBW Consulting Full time

    Principal Quality Engineer OpportunityAs a leading partner in the Contract Development and Manufacturing Organization (CDMO) sector, RBW Consulting is seeking a seasoned Principal Quality Engineer. This role is pivotal in overseeing Equipment and Facility design, as well as the Commissioning, Qualification, and Procedural Development associated with...


  • Indianapolis, Indiana, United States Pyramid Technology Solutions Full time

    Job DescriptionEducation:Master's Degree in Computer Applications, Computer Information Systems, Computer Science or related, Math, any Engineering, or Business related.Experience:0 years.Job Responsibilities:Ensure quality processes are carried out throughout all phases of the Software Development Cycle. Work concurrently on several projects, each with...


  • Indianapolis, Indiana, United States Lilly Full time

    Job Summary:We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Lead and mentor quality assurance personnel to ensure compliance with...


  • Indianapolis, Indiana, United States RBW Consulting Full time

    Principal Quality EngineerAs a prominent player in the Contract Development and Manufacturing Organization (CDMO) sector, RBW Consulting is seeking a seasoned Principal Quality Engineer. This role is pivotal in overseeing Equipment and Facility design, Commissioning, Qualification, and Procedural Development for extensive building initiatives.Supported by a...


  • Indianapolis, Indiana, United States RBW Consulting Full time

    Principal Quality EngineerAs a prominent player in the contract development and manufacturing organization (CDMO) sector, RBW Consulting is seeking a seasoned Principal Quality Engineer. This individual will serve as the primary liaison for the design, commissioning, qualification, and procedural development of equipment and facilities for large-scale...


  • Indianapolis, Indiana, United States RBW Consulting Full time

    Principal Quality EngineerAs a key player in a rapidly expanding Contract Development and Manufacturing Organization (CDMO), we are seeking a seasoned Principal Quality Engineer. This individual will serve as the primary liaison for the design, commissioning, qualification, and procedural development of equipment and facilities for large-scale construction...


  • Indianapolis, Indiana, United States RBW Consulting Full time

    Principal Quality Engineer OpportunityAs a prominent player in the Contract Development and Manufacturing Organization (CDMO) sector, RBW Consulting is on the lookout for a seasoned Principal Quality Engineer. This role is pivotal as it involves being the primary liaison for Equipment and Facility design, as well as overseeing Commissioning, Qualification,...


  • Indianapolis, Indiana, United States E-gineering, Inc. Full time

    Job OverviewLocation: RemotePosition Type: Full-time ContractAbout E-gineering, Inc.:E-gineering, Inc. is a premier software consulting firm dedicated to delivering exceptional client service through agile methodologies. Our commitment to integrity and quality drives our approach to software solutions.We cultivate a workplace culture that emphasizes...


  • Indianapolis, Indiana, United States E-gineering, Inc. Full time

    Job OverviewLocation: RemotePosition Type: Full-time ContractAbout E-gineering, Inc.:E-gineering, Inc. is a dedicated software consulting firm committed to delivering exceptional client service through agile methodologies. Our culture emphasizes a healthy work-life balance, ongoing professional development, and a supportive environment for our employees and...


  • Indianapolis, Indiana, United States Sallie Mae Full time

    Empowering Students through Quality ExcellenceSallie Mae is committed to delivering exceptional quality experiences for students. As a Senior Associate, Quality Assurance, you will play a vital role in driving this mission forward.Your Key ResponsibilitiesDevelop and maintain quality control processes and procedures to ensure compliance with regulatory...


  • Indianapolis, Indiana, United States HGC Industries Full time

    Job OverviewThe Senior Quality Assurance Technician plays a pivotal role in supporting HGC Industries' mission and core values by executing various responsibilities to ensure the Quality Management System operates effectively. This position involves leading process and documentation modifications as part of the introduction of new products, utilizing...


  • Indianapolis, Indiana, United States Aegis Worldwide Full time

    Job Title: Quality Operations ManagerWe are seeking a seasoned Quality Operations Manager to lead our QA team in a highly regulated food manufacturing environment. The ideal candidate will be responsible for developing and implementing quality control systems, ensuring compliance with industry standards and regulatory requirements, and driving continuous...


  • Indianapolis, Indiana, United States E-gineering, Inc. Full time

    Job OverviewLocation: RemotePosition Type: Full-time ContractAbout E-gineering, Inc.:E-gineering, Inc. is a premier software consulting firm dedicated to delivering exceptional software solutions. Our commitment to integrity and agile methodologies drives our success in serving clients effectively.We cultivate a workplace culture that emphasizes work-life...


  • Indianapolis, Indiana, United States Danaher Corporation Full time

    Quality Assurance Engineer RoleWe are seeking a highly skilled Quality Assurance Engineer to join our team at Danaher Corporation. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and compliance of our products and services.Key Responsibilities:Represent quality assurance on development teams and quality systems...