Quality assurance lead jobs in West Lafayette, IN - 21 jobs

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly's new Lebanon, Indiana (LP2) site. The QA Operational Support position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility. As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas: ATMP Gene Therapy Drug Substance Manufacturing ATMP Gene Therapy Parenteral Manufacturing QC Laboratory Packaging Warehouse Logistics Facility, Utility and Maintenance Responsibilities: Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase Actively participate in required design reviews and final design qualification activities Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc. Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group Support the definition and execution of inspection readiness activities including support of site self-inspections in GQA Lead project initiatives needed in support of the project and Quality function Resolve or escalate any compliance issues to the project, site, and Quality Management Provides guidance for deviations, observation handling; change control proposals; document creation and revisions. Basic Requirements: Bachelor's degree in relevant field (preference for scientific or engineering field) 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation Additional Preferences: Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing ASQ Certified Computer System Quality Assurance experience Previous facility or area start up experience Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging Previous experience with lab equipment delivery and qualification Previous experience with management of utilities, facilities, maintenance, and warehouse logistics Previous experience with Manufacturing Execution Systems. Previous use of KNEAT - or other electronic validation software Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills Demonstrated strong problem solving and decision making skills Previous technical writing experience Technical aptitude and ability to train and mentor others Additional Information: Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

BHJ USA, LLC. is a leading supplier of fresh/frozen meat blends to both the wet and dry pet food industries. We are seeking a motivated individual to assure consistent quality of production for plant by developing and enforcing good manufacturing practices (GMP) systems; validating processes, and providing documentation by performing the following duties: • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures• Maintain and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop manufacturing and training methods• Analyze and prepare responses to customer requests, including but not limited to; audits, quality statement and new specifications• Update and maintain HACCP programs and lead scheduled HACCP team meetings• Responsible for calibration and updating of in house analytical testing equipment and communication with equipment vendors regarding technical issues and updates• Responsible for developing and maintaining a Food Safety/Defense Program which complies with USDA/FDA objectives including Food Safety Modernization Act• Complete Certificate of Analysis (COA) forms• In consultation with VP Operations, oversee contact to USDA-APHIS, USDA-FSIS, Nebraska State Department of Agriculture, and FDA• Coordinate group QA initiatives with other QA Managers• In consultation with Plant Manager, responsible for ensuring plant operates in compliance with all laws and regulations• Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations• Adhere to all safety guidelines and wearing of all required safety gear (PPE)• Adhere, support, and enforce all company policies and procedures• Adhere to attendance guidelines of the company at assigned work location H.S. education or GED with at least (1-3) years experience or equivalent education and/or experience. Must also possess the following skills: • Microsoft Office (including Word and Excel)• Bilingual in English/Spanish preferred• Service oriented• Ability to communicate with people across all organizational levels• Ability to work independently and as a part of a team and treat coworkers with respect• Experience in a QA or QC role• Experience in the meat processing industry is desired but not required• Valid driver's license We support a drug free workplace and conduct pre-employment drug screening. Must be authorized to work in the U.S. We participate in E-Verify. EEO Employer. #ZR

BHJ USA, LLC. is a leading supplier of fresh/frozen meat blends to both the wet and dry pet food industries. We are seeking a motivated individual to assure consistent quality of production for plant by developing and enforcing good manufacturing practices (GMP) systems; validating processes, and providing documentation by performing the following duties: • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures • Maintain and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop manufacturing and training methods • Analyze and prepare responses to customer requests, including but not limited to; audits, quality statement and new specifications • Update and maintain HACCP programs and lead scheduled HACCP team meetings • Responsible for calibration and updating of in house analytical testing equipment and communication with equipment vendors regarding technical issues and updates • Responsible for developing and maintaining a Food Safety/Defense Program which complies with USDA/FDA objectives including Food Safety Modernization Act • Complete Certificate of Analysis (COA) forms • In consultation with VP Operations, oversee contact to USDA-APHIS, USDA-FSIS, Nebraska State Department of Agriculture, and FDA • Coordinate group QA initiatives with other QA Managers • In consultation with Plant Manager, responsible for ensuring plant operates in compliance with all laws and regulations • Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations • Adhere to all safety guidelines and wearing of all required safety gear (PPE) • Adhere, support, and enforce all company policies and procedures • Adhere to attendance guidelines of the company at assigned work location H.S. education or GED with at least (1-3) years experience or equivalent education and/or experience. Must also possess the following skills: • Microsoft Office (including Word and Excel) • Bilingual in English/Spanish preferred • Service oriented • Ability to communicate with people across all organizational levels • Ability to work independently and as a part of a team and treat coworkers with respect • Experience in a QA or QC role • Experience in the meat processing industry is desired but not required • Valid driver's license We support a drug free workplace and conduct pre-employment drug screening. Must be authorized to work in the U.S. We participate in E-Verify. EEO Employer. #ZR

Job Summary: The Quality and Compliance Manager serves Barnhart by providing awareness of and recommendations on how to best comply with Federal and State regulations, industry standards, and customer requirements. This position must develop positive relationships within the company, have a hunger to learn the complexities of the organization's needs and customer requirements, and closely monitor performances to maintain compliance. Job Responsibilities: * Ensure compliance with Barnhart's ISO 9001:2015 Quality Management System, ISO 14001:2015 Environmental Management System, ISO 45001:2018 Occupational Health and Safety Management System and Barnhart's NQA-1 Policy * Ensure both internal and external audits are conducted to determine the effectiveness of the Quality Assurance Program * Provide timely and accurate submission of necessary reports to the Company and regulatory agencies (OSHA, MSHA, BLS, CARB) * Ensure all OSHA log metrics are up to date, posted and submitted correctly * Maintain and control the Quality Assurance Manual and implemented Quality Assurance Procedures * Work with other departments to ensure efficiency and consistency of Compliance information is provided to customers * Review contract-related documents to determine applicable Quality Assurance requirements * Conduct reviews of training and indoctrination related to the Quality Assurance Program and certification of designated personnel performing quality-related work * Develop Quality Assurance Procedures to implement the requirements of Quality Assurance Program * Coordinate, review, and update third-party compliance sites (ISNetworld, Highwire, DISA, ComplyWorks, Veriforce, and NCMS) * Lead employee training sessions on compliance issues * Perform other duties and responsibilities related to the compliance activities of the Company as needed Requirements: * Three years of experience in similar industry * Prior experience with reporting to governmental agencies * CWI or ASNT VT level ll certificates * Current proof of passing a "Jager eye exam" * Prior experience managing third-party compliance systems (ex. ISNetworld, Avetta, Highwire, DISA, ComplyWorks, Veriforce, PEC, and NCMS) * General knowledge of construction industry standards, rules, and regulations (preferred) * Certifications in Safety, Compliance, or Administration (preferred) * High level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) * Good grasp of construction industry processes and HSE regulations * Excellent communication skills and ability to work with teams * Ability to work on multiple tasks simultaneously * Demonstrated analytical and problem-solving skills * Strong organizational skills and attention to detail * Ability to work well in a fast-paced environment * Willingness to train others * Pass drug screen, fit-for-duty, and background search Compensation and Benefits: * Competitive salary and performance bonus * 401(k) program with company match up to 10% of pay * Family medical, dental and vision insurance * Paid time off and other benefits * Barnhart CARES family care and community service opportunities PURPOSE - Barnhart is built on a strong foundation of serving others. The fruit of our labor is used to grow the company, care for our employees, and serve those in our communities and around the world. MINDS OVER MATTER - Barnhart has built a nationwide reputation for solving problems. We specialize in the lifting, heavy-rigging, and heavy transport of major components used in American industry. NETWORK - Barnhart has built teams that form one of our industry's strongest network of talent and resources with over 60 branch locations across the U.S. working together to serve our customers. This growing network offers our team members constant opportunity for career growth and professional development. CULTURE - Barnhart has a strong team culture -- the "One TEAM." We are looking for smart, hard-working people who strive for excellence in their work and appreciate collaboration. Join a team that values Safety, Servant Leadership, Quality Service, Innovation, Continuous Improvement, Fairness, and Profit with a Purpose. EOE/AA Minority/Female/Disability/Veteran #LI-HS1

Operations is at the heart of Amazon's business. We are known for our speed, accuracy, and exceptional service. Our buildings deliver tens of thousands of products to hundreds of countries worldwide, every day. The Reliability & Maintenance Engineering (RME) team are the business partners that work tirelessly behind the scenes to make it happen. We drive continuous improvement, and maintain all of the robotics and material handling equipment (MHE) to ensure our customers are met with the Amazon smile. Come join us on our journey! About the Role: As the Senior Regional Automation Engineer, you will engage on all aspects of high-level support for the control systems within a region of Amazon sites. This work takes the form of direct field engagement for launch and existing facilities, commissioning, on-call, continuous improvement, change management, project management, training, security, infrastructure and systems administration. You will deliver this through the use of statistics and data analytics, structured problem solving, implementation of global support mechanisms, system performance monitoring tools, identification and dissemination of best practices. In this role, you will also develop and implement standard operating procedures, optimal code/parameter sets, performance metrics, and feedback mechanisms to ensure reliability and operational efficiency of our equipment. What Do We Offer? Amazon offers competitive compensation packages including comprehensive healthcare benefits starting on Day 1, matching 401(k) program, and up to 20 weeks of paid parental leave. But wait, there's more: We provide lightweight fire-resistant daily wear and composite toe safety shoes for your safety! Key job responsibilities Key job responsibilities include, but are not limited to: - Understand and troubleshoot material handling control systems, including PLC/PC controllers, industrial networks (Ethernet, ControlNet, DeviceNet, Profibus, Profinet, ASi), motor control systems, servo drives, frequency drives, and electrical distribution systems - Apply Subject Matter Expertise (SME) on troubleshooting and dive deeps for engineering issues, supporting a region of onsite automation engineers to investigate the root cause and planning actions to eliminate/mitigate the downtime of critical assets - Programming and source coding for in-house built solutions based in PLC or PC controllers and SCADA/OEE platforms - Develop solutions related to Automation Systems - Project Management (PM) of large-scale initiatives that will require work activities coordination of site-based Automation Engineers (AE) to accomplish goals of the business - Create, optimize and monitor Key Performance Indicators (KPI) for control the efficiency, availability and quality of the machines, generating reports for improvement purposes. - Communicate with Vendors and senior leadership to plan and coordinate technical resolutions for local teams or network wide issues - Provide technical guidance and decision making for collaboration projects or initiatives with other Amazon teams, being a key stakeholder in supporting technical and major network support requests - Provide 24/7 on-call rotational support for hardware and software systems across multiple sites. - Travel up to 80% Basic Qualifications - Bachelor's degree in computer science, electrical engineering, automation engineering, or equivalent, or 7+ years of PLC programming or automation engineering experience - Work a flexible schedule/shift/work area, including weekends, nights, and/or holidays - 7+ years of industrial controls and automation experience - 7+ years of process or production environment related PLC-controlled automation and issue diagnosis experience - 7+ years of robotics work cells and control systems experience - 7+ years of Siemens, Allen-Bradley or Codesys Ladder Logic and structure programming experience - 7+ years of electrical theory, robotics, controls components, and automated equipment experience Preferred Qualifications - Advanced degree in computer science, electrical engineering, or related field - Experience with HMI and control network components, including maintenance, troubleshooting, programming and design - Experience programming with RSLogix5000, Studio 5000, FT View, and other controls software platforms - Six Sigma Black Belt, or MBA - Experience leading Controls in manufacturing or complex industrial environments Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status. Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company's reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit ********************************************************* for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner. Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $121,500/year in our lowest geographic market up to $193,100/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit ******************************************************* . This position will remain posted until filled. Applicants should apply via our internal or external career site.

Subaru of America, Inc.'s Internship Program provides a valuable opportunity for students to gain real-world experience related to their major. Interns have the chance to work on meaningful projects, collaborate with professionals, and develop skills that will be beneficial in their future careers. It's an excellent way to jump-start their career and enhance their skillset, making them more marketable in their field of study. Course of Study Pursuing a Bachelor's Degree with a major in Business Management, Business Analytics, Operations Management/Organizational Leadership Term 1 year in length [37.5 hours per week during the summer; ~18-25 hours per week during school year] Internship to begin in May and end the following May Location - Subaru Yard Operations (SYO), 5000 State Road 38 East, Lafayette, IN 47903 $20 an hour (undergrad) Qualifications Current Juniors OR Seniors planning to pursue a Master's Degree OR students currently enrolled in a Master's Program Must be an active student for the entire length of internship At least 1 year of work experience Skills Excellent verbal and written communication and interpersonal skills with the ability to interface with all levels of the organization Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) Ability to work independently and in a team environment Analytical skills Must be able to handle multiple tasks while managing deadlines Ability to use and create digital photography/videos with photo/video editing skills Responsibilities Compile and distribute daily/monthly vehicle and accessory quality reports Assist with the development of effective charts and reports Collaborate with the Accessory Quality Manager in the development of accessory work instructions and accessory installation videos Collaborate with the Vehicle Quality Manager in the review and reporting of vehicle quality Support the development and review of department processes Participate in department meetings Assist the Vehicle Quality Manager in the SYO Pre-Delivery Inspection (PDI) Program identifying inspection opportunities, documenting revisions of model year changes, and ensuring program improvements are properly documented and implemented Provide support and conduct training for on-site processor and SYO Advanced Quality Assurance (AQA) Team as necessary Summary Subaru of America's Service-Technical Advanced Quality Assurance area is a fast-paced and exciting environment. This position will provide experience and exposure to the Advanced Quality Assurance (AQA) group at Subaru, specifically in the areas of accessory and vehicle quality. The SYO-AQA team is responsible for ensuring the highest quality vehicles are delivered to retailers, with a focus on activities designed to maintain and improve accessory and vehicle quality. This position will represent SOA interests in the analysis and reporting of accessory and vehicle quality processes and concerns while having exposure to daily operations, including participating in the development of operating procedures, work instructions, and associated video.

Christian Brothers Automotive Our mission is simple: To create an uncommonly great experience for customers in need of auto service and repair. Christian Brothers Automotive was founded in 1982 on the principles of honesty and integrity. These principles have taken our organization to over 300+ locations all across the country. We strive for excellence in service as the #1 Automotive Repair Franchise in the country. We have a great culture, a great mission, and a great time. We hope you'll consider joining us! The job description will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Qualifications The qualifications will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Additional Information All of your information will be kept confidential according to EEO guidelines. Christian Brothers Automotive is an Equal Opportunity Employer.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Lilly Medicine Foundry QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and computer systems (CSQ) within the Foundry and assures compliance with quality systems and current Good Manufacturing Practices (cGMP). This oversight includes supporting drug substance manufacturing, central utilities, warehouse, and laboratory facilities. This role is part of a team supporting the design, construction, and qualification at the Foundry as this new manufacturing site is built at a green field site. **Responsibilities:** The Foundry QA Engineer provides technical guidance and leadership in a variety of interactions with business and operations personnel. More specific examples include: + Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations. + Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements. + Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems + Validation (CSV) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.). + Influence and oversee Maintenance/Calibration programs within the Foundry, including benchmarking with other Lilly sites. + Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA). + Escalate and/or initiate notification to management for departures of critical nature and assure issues are addressed appropriately. + Ensure the Foundry is audit ready at all times and participate in internal/external inspections. **Basic Requirements:** + Bachelor of Science Degree in Engineering or related field (e.g. biology, chemistry, computer science, etc. with a minimum of 3 years previous FUME engineering experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.). **Additional Preferences:** + Demonstrated relevant experience in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management systems (EDMS), Kneat, Trackwise, Maximo, etc. + Demonstrated solid judgment and initiative + Ability to organize and prioritize multiple tasks and to problem solve effectively + Ability to work under time pressure and exert good judgment in special situations + Must exhibit good teamwork, communication, and interpersonal skills sustained over time **Other Information:** + Initial location at Lilly Technology Center, Indianapolis. + Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. \#WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

Automation Technical Lead SimoTech is seeking a C&Q Automation Technical Lead to support a biotechnology client in Lebanon, Indiana, U.S.A. The ideal candidate will have 10+ years of automation experience, preferably within the biotechnology, pharmaceutical, or life sciences industries. This role is responsible for leading automation efforts across manufacturing operations and central utilities building. Key Responsibilities Managing the integration of 70 Vendor Packaged Equipment Skids across 11 different equipment types into site automation systems, while supporting commissioning activities. Overseeing software installation on virtual server infrastructure. Deploying and configuring vendor -specific SCADA applications onto virtual servers. Coordinating with IT and support teams to establish and validate network connections between PLCs, Virtual Servers, Thin Clients, OSI -PI, DeltaV, BMS, and other site systems. Supporting on -site SAT with vendors and project personnel. Establishing, testing, and validating the DeltaV interface with Allen -Bradley PLCs. Executing client Operational Verification (OV) Testing. Implementing and managing project/site change controls resulting from SAT, OV, and commissioning activities. Verifying alarm handling and event management between vendor systems, site SCADA, and control systems. Providing troubleshooting and issue resolution support throughout installation, commissioning, and qualification phases Key Requirements 10+ years of automation experience in the Life Sciences industry, with a focus on biotechnology, pharmaceuticals, or GMP -regulated environments. Bachelor's or Master's degree in Engineering, Computer Science, or a related technical discipline. Extensive hands -on experience with PLC, SCADA, and automation hardware, including; Allen Bradley ControlLogix and CompactLogix, RSLogix 5000 / Studio 5000, FactoryTalk View SE/ME & Virtualized SCADA environments and integration within IT infrastructure Exposure to various automation technologies and platforms, including; Rockwell AssetCentre, FactoryTalk Directory & FactoryTalk Security, MS SQL Server, Vendor -specific PLC and embedded control technologies for utilities systems Working knowledge of automation industry standards, including; GAMP 5 software development lifecycle methodologies & ANSI/ISA -S88 batch control standards Excellent problem -solving and troubleshooting skills, with the ability to diagnose and resolve automation -related issues under pressure to meet project deadlines. Strong collaboration and communication skills, with the ability to work effectively within diverse, cross -functional, and multi -disciplinary teams. What SimoTech Can Offer Role provides a high degree of autonomy to allow the successful candidate to reach their full potential. Develop new skills and enhance technical ability by working with innovative technologies in a multi -disciplined environment. Opportunity to work with large corporate clients on exciting capital projects. Additional Information SimoTech is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Quality Assurance Manager An Opportunity you Do-Nut want to miss! To become the world's greatest baker, we need the world's greatest team members As Quality Assurance Manager (QA Program Leader), you will be responsible for designing, executing, and assisting in the day-to-day management of QA activities in our manufacturing plants. You will be leading a team consisting of QA technicians, all within a fast-paced food manufacturing environment. What FGF Offers: * FGF believes in Home Grown Talent, accelerated career growth with leadership training, and unleashing your potential. * Competitive Compensation, Health & Welfare Benefits including Vision & Dental, and flexible options at competitive premiums. * 401 (k) matching program * Discount program - Restaurants, gyms, shopping, etc. * Tuition reimbursement Primary Responsibilities * Manage and lead the QA team across 3 shifts, ensuring that tasks are conducted consistently, efficiently, and meet the needs of the business. * Developing a constructive work environment through excellent interpersonal, team-building skills, leadership, open communications, encouraging input, and constructive performance management. * Work with all levels of management in providing expertise, technical support, recommendations, and leadership as it pertains to QA and Food Safety activities. * Review the implementation and efficacy of the quality systems by conducting regular internal audits, which support the GFSI program * Lead HACCP, GMP, and BRC program, including updates, maintenance, verifications, and validation as required. * Act as a cross-functional liaison to ensure all plants are meeting regulatory and compliance requirements for all stakeholders. * Scheduling and conducting monthly GMP, internal, and external audits with your cross-functional team. Coordinate and lead 3rd party audits * Complete supplier audits as required and evaluate suppliers based on risk * Evaluate audit findings and implement and/or recommend appropriate corrective and preventive actions, ensuring effective closure. * Introduce and support innovative approaches to current audit best practices while simultaneously working with the team to document new policies and practices as required. * Identify training needs supporting the Quality and Food Safety programs and organize training. * Perform GMP, HACCP technical and SOP training as required. * Draft and implement quality assurance/food safety policies and procedures * Assist with cross-functional SOP development and ensure that facility SOPs and related documents are in the correct format, properly stored, and distributed as per manufacturing excellence requirements * Conduct a Risk Assessment for all quality-related non-conformities and work on solving the most critical items. * Conduct Root Cause Analysis to solve critical non-conformities. Knowledge in the 5Why process is an asset. * Assist in follow-up and issue any corrective actions, if necessary, based on deviations found in the plant process or resulting from customer complaints. * Ensure that the pest control program is being maintained and liaise with the operation to ensure that all requirements are met. * Maintaining an attitude of continuous process improvement and training of Team Members Required Experience * Postsecondary degree in a relevant field (preferably Biology or Food Science) * A minimum of 5 years in a QA leadership role within a food manufacturing environment is required * Internal auditor training/certificate * Knowledge and experience of HACCP, GMPs * Experience with the implementation and maintenance of a GFSI audit program * Experience and/or education in continuous improvement, Six Sigma, or lean manufacturing is highly desirable * Strong leadership and team-building skills * Strong interpersonal and communication skills * Excellent MS Office skills What is the recipe for a great career at FGF? Working at FGF Brands, there is never a dull moment! FGF is a leading North American bakery company with facilities across the USA and Canada with a specialized focus across all key bakery categories, including naan, muffins, croissants, donuts, cakes, artisan breads, and flatbreads. As an innovative company that is continually growing, there is always challenging yet rewarding work to be a part of. We have an entrepreneurial spirit that encourages all our Team Members to use their creativity and out-of-the-box thinking to come up with solutions and new ideas. #LI-ONSITE #LI-CO1 Job Family Quality Assurance Job Level A-HO

Job Description General Construction Quality Assurance Manager helps create, plan, manage, and enforce our Quality Assurance Program for the Company by identifying potential issues, then creating/implementing a specific plan in order to eliminate any errors that could result in a quality deficient product. By utilizing experience, expertise, and training, the Quality Assurance Manager shall ensure that all projects meet or exceed the quality assurance standards of F. A. Wilhelm Construction and our customer. Essential Functions Develop and implement a job specific Quality Assurance Program • Enforce the F. A. Wilhelm Construction Quality Assurance Program • Understand the Quality Assurance needs for all scopes of work which is performed including excavation, concrete, masonry, steel and building enclosures - Implement and provide continuous improvement of the project's Quality Assurance program - Develop and ensure that the inspection and testing programs are executed - Ensure that all personnel working on the project understand the construction methods and code requirements - Recommend and implement corrective action based on policies, guidelines, and procedures - Perform internal audits, inspections, record observations, or nonconformances from job site audit - Track nonconformances and their corrective actions and ensure the Wilhelm Rework cost control process is being utilized properly - Lead the development of quality goals for the project - Evaluate need for training and make recommendations for additional training - Train staff as needed on related quality items • Support project team members in the development of preconstruction agendas, assist with scope review, technical questions, code research or trouble shooting • Other duties as assigned by Company Management Computer Equipment and Software Requirements • Microsoft Windows - intermediate to advanced knowledge • Microsoft Office - intermediate knowledge • Viewpoint - intermediate knowledge • Bluebeam - intermediate knowledge Physical Requirements • Lifting, moving, pushing, pulling, and/or carrying items up to 50 lbs. or more • Ability to perform a variety of construction tasks in all areas and aspects of the project including but not limited to scaffolding, platform work, confined spaces, and exposure to outside elements • Must be able to see well, naturally or with correction and coordinate the movements of eyes, hands and fingers • Climbing and maintaining balance on ladders and scaffolding • Standing and/or walking for long periods, often times over uneven or unpaved ground • Stooping, kneeling, crouching, crawling or working at heights as required Education and Experience Requirements • Minimum of 5 - 10 years of Quality Assurance Management experience in construction or similar industry • Bachelor of Science Degree • Minimum OSHA 10 Hour Certification Skills and Knowledge • Thorough knowledge of general construction methods • Thorough knowledge of the AISC Fabrication and Erection Requirements • Experience in Quality & Inspection of Structural Steel • Thorough knowledge of OSHA standards • CWI is helpful, but not required • Excellent verbal and written communication skills are essential • Capable of successfully solving difficult contract and contract-related technical problems requiring excellent judgment Working Conditions • Work is performed both indoors and outdoors and may be done on a surface environment, at extreme heights, underground or above or under water • Work requires sustained physical effort, frequently under adverse weather conditions and/or disagreeable working conditions • Exposed to moving mechanical parts, fumes or airborne particles, risk of electrical shock • Noise levels are typically moderate to very loud • Due to varied conditions, workers must know the hazards and safety requirements of each job and must wear appropriate personal protective equipment as required by the company's safety policies for every situation. Powered by ExactHire:188228

Design and develop products for customer needs. Test and research data and products to ensure customer satisfaction. Attention to detail and team orientation needed to maintain an organized and successful environment. Essential Functions: * Design manufacturable and cost-effective product designs to meet market needs. * Work with marketing to establish design objectives. * Provide technical information concerning manufacturing, materials, properties and process advantages and limitations, which affect long-range plant and product engineering planning. * Prepares and directs preparation of product layout, detailed drawings, and schematics. * Utilize knowledge of manufacturing processes, GD & T, and various problem solve tools (Root cause, FMEAs, etc.) * Compile and analyze operational, test and research data to establish performance standards for newly designed or modified equipment or product. * Coordinate manufacturing or building of prototype products or systems under direction of Project Engineer or Engineering Manager. * Work with vendors to derive the best product for Hendrickson's requirements. * Other duties as assigned. * Maintain regular attendance. Education and Training * Bachelor's degree in engineering-related field or associate degree with two years relevant work experience required. Minimum Qualifications * Three to five plus years of experience in manufacturing, preferably in related industry. * Mechanically perceptive and creative/innovative with hands-on orientation. * Ability to manage multiple projects simultaneously. * Working understanding and knowledge of Computer Aided Design and Analysis tools. * Strong organizational and follow-up skills. * Work collaboratively in a team-oriented environment. * Occasional travel required. Physical Demands * Must be able to remain in a stationary position constantly. * Frequently need to move about inside office designated area. Environmental Conditions * Frequently exposed to office designated area. Behavioral Traits * Attention to Detail. * Development and Continual Learning. * Self-Management. * Teamwork. * This is not a comprehensive list of duties. Duties may change without notice in management's sole discretion. Hendrickson is an at-will employer, each employee is free to resign at any time, just as Hendrickson is free to terminate employment at any time without cause or notice. Hendrickson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

Job Title: Quality/Test Engineer Zip Code: 47901 Duration: 12 Months Pay Rate: $36.8/hr Keyword's: #Lafayettejobs; #TestEngineerjobs. Supplier Quality Engineer: * Work closely with Production and Engineering teams to Investigate supplier quality issues and ensure the issues to be well defined and communicated to the cross-functional team. * Assess the impact of supplier issues and work with Supplier, Production Planning and Logistics teams to mitigate production line downtime risk. * Manage the disposition of the defective supplier parts and coordinate return and rework of concerned parts with suppliers and 3rd party service companies. * Help root cause analysis and provide fact & data-based information to concerned parties for problem solving. * Manage deviation and process change requests from suppliers. Review and follow up supplier PPAPs. Support NPI projects. * Manage supplier performance data and financial chargeback for incurred cost from supplier quality issues. Education & Experience Required: * Years of experience: 2-4 years in the manufacturing industry. * Degree requirement: Bachelor"s degree or equivalent work experience * Do you accept internships as job experience: yes * Are there past or additional job titles or roles that would provide comparable background to this role: quality engineer, manufacturing engineer, quality technician. Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

Job Description Who we are Skjodt-Barrett is a world-class manufacturer of food solutions and custom ingredients for North America's most beloved and trusted brands. We take pride in working closely with our customers to understand their unique needs and create innovative, individualized solutions that deliver joy to their customers. A family-founded company started over 35 years ago, we are backed by the investment company Axel Johnson Inc (AJI). With their investment and support, we are well-positioned to foster growth and explore new opportunities. Our customers, blue-chip international brands and mid-sized producers alike, are why we exist. Our teams of innovators, communicators, and managers are the people who meet their needs, build trust, and exceed their expectations. Who we need Reporting to the Quality Assurance Supervisor, we are looking for a Senior Quality Assurance Technician to join our state-of-the-art food production plant in Lebanon, Indiana. You will play a critical role in performing and supporting daily QA activities across both the production floor and the laboratory. You will execute sampling programs, conduct verification checks, support investigations, maintain quality documentation, and provide guidance to QA Technicians to ensure compliance with internal standards and regulatory requirements. This is an on-site role. Who you are You bring hands-on experience as a QA Technician in a regulated manufacturing environment - food, beverage, pharmaceutical, or similar. You understand how quality programs operate in real production settings, and you are motivated by the opportunity to elevate standards and contribute to a culture of continuous improvement. You want to work for a company where your contributions are valued, where you can collaborate across teams, and where you can grow your career in QA and beyond. What's in it for you Autonomy and influence. You will play an essential role in maintaining our position as a leading manufacturer of innovative food products. You will independently perform technical sampling, verification checks, and quality monitoring programs, while providing support to QA Technicians and contributing to daily operational excellence. Impact. You will help strengthen our quality culture by ensuring every product meets the highest standards of safety, compliance, and consistency. Your work in inspections, investigations, sampling, and documentation will directly influence production performance, customer satisfaction, and audit readiness. Career development. You will join a collaborative QA team that values transparency, respect, and learning. This role is ideal for a seasoned QA Technician ready to step into a senior-level position with the opportunity to gain deeper investigative experience, support Quality Management System programs, and grow toward leadership or specialized QA roles. How you will make an impact: Perform sampling and testing. You will complete internal and external sampling activities, fulfill customer sample requests, collect retained samples, and maintain retention programs. You will conduct routine sampling for environmental monitoring programs in light, water, air, and nitrogen. Work on the production floor and in the lab. You will divide your time between the floor and the laboratory, performing hands-on verification checks, reviewing product quality, conducting testing, and supporting QA Technicians completing line checks. Lead verification and inspection activities. You will perform GMP self-inspections, conduct verification checks (including equipment verifications), complete routine audits, and ensure all documentation is accurate and audit-ready. Support investigations. You will assist in deviation investigations, including participating in equipment inspections, completing swabbing, coordinating sample pulls, gathering documentation, and collaborating with Production, Maintenance, and Warehouse teams to support root cause analysis and corrective actions. Collaborate across teams. You will work closely with Production, Maintenance, Warehouse, and Purchasing to ensure product quality and program compliance. You will support equipment or process deviations, help locate warehouse samples, and verify that standards are maintained. Support QMS program execution. You will complete administrative tasks, including program trackers, verification logs, routine reports, and other documentation required to support QA programs. You will help ensure that all programs are current, accurate, and audit-compliant. Provide support for QA Technicians. You will assist floor Technicians with questions, troubleshooting, sample pulls, and verifications. You will provide off-shift or PTO coverage to ensure continuity of testing, inspections, and documentation. What you bring to the role: The experience. You have experience in quality assurance, quality control, or a related function within a regulated manufacturing environment. You understand how manufacturing quality programs operate and have hands-on experience conducting sampling, inspections, audits, and verifications. The technical skills. You have strong knowledge of GMP, HACCP, and quality management systems. You are proficient in Microsoft Office and quality data systems. You bring analytical thinking, accuracy, and a strong attention to detail. The adaptability and communication. You are able to work across departments, building relationships with Production, Maintenance, Warehouse, and other teams. You communicate clearly, adapt to shifting priorities, and maintain composure in a fast-paced environment. The approach. You bring a continuous improvement mindset, strong organization, and a proactive sense of ownership. You are not new to quality-you have the confidence and experience to step into a senior technical role and support both daily operations and long-term quality initiatives. Why join? We've got great taste. We care deeply about fostering a culture of transparency, responsibility, and integrity. It's what drives us to make great-tasting, convenient, and healthy ingredients and finished products that our customers depend on. With a focus on nurturing and growing our employees' careers and professional satisfaction, we believe in open communication, idea sharing, and knowledge building. Skjodt-Barrett is committed to building an inclusive culture that helps to create longevity, growth, and innovation in the food industry. We are working towards a sustainable future. We believe that what's good for people and the planet is good for profit. It is everyone's responsibility to do their part. We recognize the growing need to prioritize sustainability in manufacturing, and we continue to take steps to evolve. We strive to accelerate the adoption of sustainable packaging and food products to be a responsible partner for our customers and for the greater good. We take our role as a supply chain partner to heart and adhere to a strict Supplier Code of Conduct to ensure that our vendors uphold the integrity and values we live by. We believe actions speak louder than words. Every day, we come together to exceed the expectations of our customers, each other and ourselves, inspired by our values: We care. About family, honesty, and respect. We communicate. Across every level, often, effectively, and clearly. We Empower. With trust, integrity, and accountability. We Deliver. Every time, through teamwork, innovation, and results. Apply now. At Skjodt-Barrett, we aim for diversity, equality, accessibility and inclusion in all of our operations and interactions. We welcome and appreciate candidates with a range of backgrounds and experiences. If you have 70% of the qualifications we are looking for and want to play an integral role in delivering innovative food product solutions, apply to express your interest. What you can expect from our interview process: A virtual interview with a Talent Advisor discussing your interest in the role and the company. The conversation will be recorded using BrightHire, an AI-powered video interview tool. More details will be shared when you are invited to interview. An on-site interview with the Plant QA Manager and QA Supervisor, including a tour of the facility to give you a closer look at the environment and team. A virtual interview with the QA Director and Plant Manager, where you will discuss your experience in quality, your approach to collaboration, and your alignment with the team's needs. Skjodt-Barrett welcomes and encourages applications from people with disabilities. Please let us know what accommodations you require across the selection process. #LI-DNI Powered by JazzHR VmGGuldjBu

Job Description BHJ USA, LLC. is a leading supplier of fresh/frozen meat blends to both the wet and dry pet food industries. We are seeking a motivated individual to assure consistent quality of production for plant by developing and enforcing good manufacturing practices (GMP) systems; validating processes, and providing documentation by performing the following duties: • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures • Maintain and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop manufacturing and training methods • Analyze and prepare responses to customer requests, including but not limited to; audits, quality statement and new specifications • Update and maintain HACCP programs and lead scheduled HACCP team meetings • Responsible for calibration and updating of in house analytical testing equipment and communication with equipment vendors regarding technical issues and updates • Responsible for developing and maintaining a Food Safety/Defense Program which complies with USDA/FDA objectives including Food Safety Modernization Act • Complete Certificate of Analysis (COA) forms • In consultation with VP Operations, oversee contact to USDA-APHIS, USDA-FSIS, Nebraska State Department of Agriculture, and FDA • Coordinate group QA initiatives with other QA Managers • In consultation with Plant Manager, responsible for ensuring plant operates in compliance with all laws and regulations • Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations • Adhere to all safety guidelines and wearing of all required safety gear (PPE) • Adhere, support, and enforce all company policies and procedures • Adhere to attendance guidelines of the company at assigned work location H.S. education or GED with at least (1-3) years experience or equivalent education and/or experience. Must also possess the following skills: • Microsoft Office (including Word and Excel) • Bilingual in English/Spanish preferred • Service oriented • Ability to communicate with people across all organizational levels • Ability to work independently and as a part of a team and treat coworkers with respect • Experience in a QA or QC role • Experience in the meat processing industry is desired but not required • Valid driver's license We support a drug free workplace and conduct pre-employment drug screening. Must be authorized to work in the U.S. We participate in E-Verify. EEO Employer. #ZR

Christian Brothers Automotive Our mission is simple: To create an uncommonly great experience for customers in need of auto service and repair. Christian Brothers Automotive was founded in 1982 on the principles of honesty and integrity. These principles have taken our organization to over 300+ locations all across the country. We strive for excellence in service as the #1 Automotive Repair Franchise in the country. We have a great culture, a great mission, and a great time. We hope you'll consider joining us! The job description will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Qualifications The qualifications will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Additional Information All of your information will be kept confidential according to EEO guidelines. Christian Brothers Automotive is an Equal Opportunity Employer.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Lebanon Advanced Therapies (LP2) Quality Assurance External Manufacturing Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. LP2 External Manufacturing Quality Assurance maintains communication and working relationships with alliance partners, contract manufacturers, and internal customers. The External Manufacturing QA Representative manages daily contract manufacturing activities and ensures adherence to Lilly GQS and cGMPs through deviation investigations, change control, documentation management, validations, and other relevant responsibilities. This position also supports inspection readiness, product launches, and is accountable for batch disposition, confirming all batches comply with specifications and regulatory requirements. Responsibilities: Serve as a liaison between CMs and Lilly, providing quality oversight and serving as the initial point of contact for all quality-related issues Escalate quality issues at CMs to Lilly QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs) Evaluate and disposition drug substance, drug product, and packaging batches ensuring that documented checks have been completed for the Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes and batch documentation Provide quality support of manufacturing operations with holistic review of key activities associated with or impacting the manufacturing processes. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations Provide onsite support of manufacturing operations as required Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections Participate in APR activities Participate in Post Launch Optimization Teams (PLOT) Basic Requirements: Bachelor's degree in relevant field (preference for scientific or engineering field) 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles Previous experience providing Quality Assurance oversight of contract manufacturers Additional Preferences: Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing ASQ Certified Previous facility or area start up experience Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging Previous experience with Manufacturing Execution Systems. Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills Demonstrated strong problem solving and decision-making skills Previous technical writing experience Technical aptitude and ability to train and mentor others Additional Information: Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office Position may require travel (10-25%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. **Organization Overview:** Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly's new Lebanon, Indiana (LP2) site. The QA Operational Support position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility. As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas: + ATMP Gene Therapy Drug Substance Manufacturing + ATMP Gene Therapy Parenteral Manufacturing + QC Laboratory + Packaging + Warehouse Logistics + Facility, Utility and Maintenance **Responsibilities:** + Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance + Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design + Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase + Actively participate in required design reviews and final design qualification activities + Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures + Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc. + Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas + Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff + Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group + Support the definition and execution of inspection readiness activities including support of site self-inspections in GQA + Lead project initiatives needed in support of the project and Quality function + Resolve or escalate any compliance issues to the project, site, and Quality Management + Provides guidance for deviations, observation handling; change control proposals; document creation and revisions. **Basic Requirements:** + Bachelor's degree in relevant field (preference for scientific or engineering field) + 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles + Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation **Additional Preferences:** + Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing + ASQ Certified + Computer System Quality Assurance experience + Previous facility or area start up experience + Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packaging + Previous experience with lab equipment delivery and qualification + Previous experience with management of utilities, facilities, maintenance, and warehouse logistics + Previous experience with Manufacturing Execution Systems. + Previous use of KNEAT - or other electronic validation software + Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills + Demonstrated strong problem solving and decision making skills + Previous technical writing experience + Technical aptitude and ability to train and mentor others **Additional Information:** + Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office + Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

Christian Brothers Automotive Our mission is simple: To create an uncommonly great experience for customers in need of auto service and repair. Christian Brothers Automotive was founded in 1982 on the principles of honesty and integrity. These principles have taken our organization to over 300+ locations all across the country. We strive for excellence in service as the #1 Automotive Repair Franchise in the country. We have a great culture, a great mission, and a great time. We hope you'll consider joining us! The job description will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Qualifications The qualifications will be dependent upon the position that you are interested in. This is an opportunity to apply for general consideration. Additional Information All of your information will be kept confidential according to EEO guidelines. Christian Brothers Automotive is an Equal Opportunity Employer.