Lead Investigator

1 week ago


Marquand, Missouri, United States Merck KGaA Full time
About the Role

The Lead Investigator will oversee and conduct investigations in accordance with company policies, applicable cGMP FDA, EMA, and other global pharmaceutical regulations.

Key Responsibilities
  • Maintain oversight of the QA program from a QMS perspective, ensuring compliance and on-time closures.
  • Collaborate with cross-functional teams, facilitate problem-solving, and drive continuous improvement efforts.
  • Write, review, and approve Deviations, CAPAs, Complaints, as required.
  • Lead and inspire cross-functional teams, fostering a culture of compliance and continuous improvement.
  • Client facing meetings to drive timely closure of investigations.
  • Investigate deviations/non-conformances of all levels: MINOR, MAJOR, and CRITICAL.
  • Create SMART CAPAs and Effectiveness Checks as necessary.
  • Track and trend data.
Requirements
  • High School Diploma or GED.
  • 5+ years of experience in Quality Assurance or compliance within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing environments.
Preferred Qualifications
  • Experience with cGMP, Data Integrity, and Quality Systems.
  • Experience successfully leading and managing investigations and CAPAs.
  • Experience collaborating with regulatory agencies and conducting audits or inspections.


  • Marquand, Missouri, United States Department Of Justice Full time

    About the RoleThis is a challenging and rewarding opportunity to join the Department of Justice as a Supervisory Law Enforcement Investigator. As a key member of our team, you will be responsible for leading a group of investigators in the prevention, detection, and investigation of crimes related to the enforcement of laws.Key ResponsibilitiesLead a team of...


  • Marquand, Missouri, United States Bureau of Alcohol, Tobacco, Firearms, and Explosives Full time

    Job SummaryThis position is located under the Office of Field Operations, Columbus Field Division, Indianapolis III Field Office.We are seeking a highly skilled and experienced Supervisory Criminal Investigator to join our team at the Bureau of Alcohol, Tobacco, Firearms, and Explosives.Key ResponsibilitiesPrevent, detect, and investigate substantive and...


  • Marquand, Missouri, United States VETERANS HEALTH ADMINISTRATION Full time

    Job SummaryThis position serves as the Lead Security Assistant for Police Services Operations Dispatch Center, at Richard L. Roudebush VA Medical Center (VAMC) within the Veterans Health Administration (VHA) with a primary purpose to lead a team of Security Assistants responsible for monitoring physical security equipment and systems.Key...


  • Marquand, Missouri, United States Ingredion Full time

    POSITION:Process LeadLOCATION:IndianapolisREPORTS TO:Unit ManagerThe Process Lead serves as a key technical resource, leveraging expertise in process and manufacturing methodologies. This role is pivotal in the formulation and execution of production strategies, troubleshooting, and continuous enhancement initiatives aimed at maximizing operational...


  • Marquand, Missouri, United States Ingredion Full time

    POSITION:Process LeadLOCATION:IndianapolisREPORTS TO:Unit ManagerThe Process Lead serves as a vital technical resource, leveraging expertise in process and manufacturing methodologies. This role is pivotal in the formulation and execution of production strategies, troubleshooting, and continuous enhancement initiatives aimed at maximizing operational...


  • Marquand, Missouri, United States Stantec Full time

    **Become a Key Player in Hydrogeology** Company: Stantec At Stantec, we prioritize safety, quality, and ethical practices. Our team comprises experts who lead their respective fields, guiding our initiatives with precision, creativity, and a vision for sustainable growth. We leverage over 20 technical specialties worldwide and are dedicated to cultivating an...


  • Marquand, Missouri, United States Linde Advanced Material Technologies Full time

    Facilities Maintenance SupervisorLocation: United StatesKey Responsibilities:Oversee the daily activities of maintenance personnel to ensure efficient production support.Utilize CMMS software to enhance preventative maintenance efforts and address recurring downtime challenges.Champion the Total Productive Maintenance (TPM) initiative within the...


  • Marquand, Missouri, United States Seismic Full time

    Lead Software Architect - SeismicSeismic, a prominent innovator in sales enablement solutions, is seeking a dedicated developer to become part of their engineering team as a Lead Software Architect. This position focuses on enhancing and expanding cloud-based infrastructures with an emphasis on software excellence and operational integrity.Key...


  • Marquand, Missouri, United States VETERANS HEALTH ADMINISTRATION Full time

    Job SummaryThis position serves as the Lead Security Assistant for Police Services Operations Dispatch Center, at Richard L. Roudebush VA Medical Center (VAMC) within the Veterans Health Administration (VHA) with a primary purpose to lead a team of Security Assistants responsible for monitoring physical security equipment and systems.Key...


  • Marquand, Missouri, United States Novartis Full time

    Position Overview At Novartis, we are at the forefront of innovation in nuclear medicine, dedicated to advancing targeted radioligand therapy (RLT) for cancer patients. We seek a seasoned professional in the pharmaceutical sector with expertise in validation, maintenance, engineering, or quality assurance to join our team at a new manufacturing facility....


  • Marquand, Missouri, United States Novartis Farmacéutica Full time

    About Novartis:At Novartis Farmacéutica, we are dedicated to pioneering advancements in nuclear medicine, focusing on the development of targeted radioligand therapies (RLT) for cancer treatment.Position Overview:The Lead Facilities Engineer plays a crucial role in ensuring the optimal performance and enhancement of the site’s infrastructure and utility...


  • Marquand, Missouri, United States Johnson Controls International Full time

    About the RoleWe are seeking a highly skilled and experienced Mechanical Project Team Lead to join our team at Johnson Controls International. As a key member of our project management team, you will be responsible for the overall execution and performance of mechanical retrofit projects.Key ResponsibilitiesProject Planning and Execution: Plan, execute, and...


  • Marquand, Missouri, United States Langham Logistics Full time

    Overview:The Lead Accounting Specialist plays a vital role in achieving Langham Logistics' objectives of outstanding customer service, quality assurance, process enhancement, and profitability. This position is responsible for overseeing accounts receivable, ensuring adherence to established protocols, and managing daily financial transactions to guarantee...


  • Marquand, Missouri, United States Eli Lilly Full time

    Job SummaryEli Lilly is seeking a highly skilled Chemist - Quality Control Specialist to provide technical and compliance support for our Indianapolis API Operations QC team. The successful candidate will be responsible for designing and executing validated computer systems, managing analytical methods, and providing support for electronic notebook templates...


  • Marquand, Missouri, United States Defense Finance and Accounting Service Full time

    Job SummaryWe are seeking a highly skilled Lead Financial Specialist to join our team at the Defense Finance and Accounting Service. As a key member of our financial management team, you will be responsible for providing financial management advice and performing duties such as training, monitoring work status, mentoring, and integrating the organization's...


  • Marquand, Missouri, United States Langham Logistics Full time

    The Lead Accounting Specialist plays a crucial role in achieving Langham Logistics' objectives of outstanding customer service, quality assurance, process enhancement, and profitability. This position involves overseeing accounts receivable, ensuring adherence to established protocols, processing daily transactions, and guaranteeing that all payments for...


  • Marquand, Missouri, United States Stantec Full time

    **Become a Key Player in Hydrogeology** Company: Stantec At Stantec, we prioritize safety, quality, and ethical practices. Our team comprises experts who excel in their respective fields, guiding our initiatives with precision, creativity, and a vision for sustainable growth. We leverage over 20 technical specialties worldwide and are dedicated to...


  • Marquand, Missouri, United States Novartis Group Companies Full time

    Job SummaryWe 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.Main ResponsibilitiesProvide technical QA...


  • Marquand, Missouri, United States BioSpace, Inc. Full time

    Position OverviewAt BioSpace, Inc., we are dedicated to enhancing lives through innovative healthcare solutions. As a prominent player in the biopharmaceutical industry, we strive to discover and deliver transformative therapies that improve patient outcomes globally. Our workforce is committed to excellence, and we prioritize the well-being of our...


  • Marquand, Missouri, United States Defense Finance and Accounting Service Full time

    Job SummaryWe are seeking a highly skilled and experienced Human Resources Assistant Lead to join our team at the Defense Finance and Accounting Service. As a key member of our Human Resources team, you will be responsible for providing administrative and technical support in the classification and personnel management process.Key ResponsibilitiesLead and...