Quality assurance specialist jobs in Indianapolis, IN

Our Labcorp site in Greenfield, IN, is currently recruiting for a Quality Auditor to support our toxicology team. We are looking for someone with at least 2 years in a GLP regulatory environment. Experience with the FDA's Good Laboratory Practices 21 CFR Part 58 is strongly preferred. Within the early development area: dose formulation, dose analysis, animal operations, clinical pathology and anatomic pathology operations support pre-clinical studies. We structure ourselves to deliver scientific expertise to our clients, collaborating closely with them to support the development of medicinal products through the drug development process and onto the market. This role supports the early development area as a Quality Auditor. You will perform quality audit reviews in pre-clinical studies. This position is at Greenfield, IN. facility at 671 South Meridian Road (This position is not remote). This position is not eligible for visa sponsorship. The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and where applicable for specific study types participate in internal facility/process and/or supplemental inspections, initiates, and reviews SOPs and prepares and delivers training in performance of audits. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role. Job Duties and Responsibilities: • Conduct, but not limited to protocol review, report/data audits, and internal facility/process inspections • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution • Report on relevant quality metrics (for multiple topics/departments) and highlight trends • Peer review QA SOPs • Support operational liaison meetings representing QA function • Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed Minimum Education and Experience Requirements: • Minimum: Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience) • Experience may be substituted for education • 2 years in a GLP regulatory environment required and more GLP experience is a plus • Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance • Experienced GxP auditor • Able to interpret data and identify quality critical problems • Able to convey regulatory expectations Preferred Qualifications: • Experienced in process improvement and quality auditing • Demonstrated ability to apply critical thinking skills • Clear communication skills, including ability to provide clear feedback • Able to clearly articulate processes to provide training • Able to influence process improvement initiatives and offer solutions • Experience in an FDA 21 CFR Part 58 environment highly preferred Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary Reports to Manager, Quality Assurance. QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. Authorized to inspect products to ensure the required quality standards are met. Responsibilities Inspecting and sampling of product throughout the manufacturing process. Establish and maintain quality control procedures. Assist in determining types of tests to be performed as well as documentation and reporting requirements. Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products. Champion Quality, GMP compliance and EHS/Radiation Safety practices. Develop and lead GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements. Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems. Assists in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations. Responsible for the review and dispositioning of incoming raw materials and components. Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements. Responsible for approval of minor Quality Events. Ability to network across business and functional units to achieve positive outcomes. Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product. Understands technical/release product issues and evaluate their potential impact on product quality and compliance. Provides ideas for continuous improvement of the GMP Quality Management System. Escalates complex issues to management in a timely manner. Prioritizes and ensures work is delivered in an efficient way. Performs other job duties as assigned. Qualifications Bachelor's degree in related field, or equivalent work experience, preferred. Advanced Degree may be preferred 4-8 years' experience in related field, preferred What is expected of you and others at this level Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives Completes work independently receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with my FlexPay Flexible spending accounts (FSAs) Short- and long-term disability coverage Work-Life resources Paid parental leave Healthy lifestyle programs Application window anticipated to close: 10/07/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here

Atlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in Denver, CO, Atlas currently has over 3,500 employees with offices throughout the US, including Alaska & Hawaii. It s no accident that Atlas creates a better experience for infrastructure and environmental projects. It s how we are built with the best people in the industry, with the reach and expertise to help at any and every step of the project, and with a heart-led approach that puts quality and safety at the center of everything we do. We re just built to be better. We are a great company. We are seeking a Construction Quality Assurance Field Technician (EN Engineering Assistant) to join our team. This person could report to one of the following branches: Indianapolis IN, Evansville IN, or Louisville KY teams! Come join us! Job responsibilities include but are not limited to: Perform Construction Quality Assurance (CQA) monitoring, primarily related to landfills, solid waste, and coal combustion residuals projects. Perform Construction Material Testing projects when CQA is not working. Communicate effectively with Atlas engineering staff and contractors, Field Testing and Inspection. Accurately record test and daily field observations on large scale landfill projects. Follow Atlas Directives and standards and perform all job functions within Atlas (and client) safety guidelines. Abide by Atlas (and client) health and safety policies and procedures. Minimum requirements: High school diploma or equivalent educational background. Ability to accurately follow verbal and written instructions and communicate effectively with task and project leaders Reasoning, mathematical and language skills (read, write and speak acceptable business English) Strong interpersonal skills Physical strength, stamina and dexterity to lift and move 70 lbs, stop, bend and stand throughout the course of up to a 12-hour workday in varying weather conditions in varying terrain Valid Driver License Must be willing to work a flexible schedule on large, out of town, construction projects including weekends when necessary Must be able to assist field staff as directed by engineering support staff Ability to pass criminal background checks Assist other departments and clients as necessary. Technical requirements: Must be familiar with Microsoft Office (Word and Excel). At least two (2) years experience with concrete, soils, and asphalt testing is preferred, but not required Must be able to read and understand project drawings and project specifications. Experience in Construction Quality Assurance is a plus Experience with nuclear density gauges and landfill liner inspections is a plus. Other miscellaneous qualities: Ability to travel as necessary for job related duties. Benefits: Atlas offers a comprehensive benefit program to meet the diverse needs of our employees. Depending on your employment status, Atlas benefits include health, dental, vision, life, AD&D, voluntary life / AD&D, disability benefits, leaves of absence, 401k, paid time off, paid holidays, employee assistance program, educational assistance program. Who We Are: We strive to be the most sought-after infrastructure and environmental solutions company, known for our unique, values-driven approach and brought to life by the industry s most exceptional people. Atlas provides professional testing, inspection, engineering, environmental and consulting services from more than 100 locations nationwide. We deliver solutions to both public and private sector clients in the transportation, commercial, water, government, education and industrial markets. With a legacy of providing consistent quality and results, Atlas creates a better experience at every stage of an infrastructure project. We connect the best experts in the industry to deliver value from concept to completion and beyond. This means doing everything our clients expect and then raising the expectations in a way that only our people can. Our Values: Life: We enhance quality of life. We value people and safety above all else. Heart: As our hallmarks, we act with compassion, empathy and respect. Trust: We work together as partners, doing what we say with full accountability. Mastery: Always striving for the highest quality, we ensure greatness inspires all our work. Atlas EEOC Statement Atlas is an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Atlas makes hiring decisions based solely on qualifications, merit, and business needs at the time. For more information, read through our EEO Policy ******************************************************************************************** #LI-KS2

R&D Partners is seeking to hire a Document Specialist in Indianapolis, IN. Your main responsibilities as a Document Specialist: Creates technical and sales instructor-led training content job aids, technical guides, and other training materials. Interface with content originators, stakeholders, and approvers to ensure cross-functional team alignment on training documentation. Monitor systems to ensure documents and workflows are approved in a timely manner. Effectively communicate and train to process improvement opportunities and technical content management system updates in Training and Development approval areas. Revises technical and sales training materials and content to include adherence to brand standards and necessary modifications found in periodic review cycles. What we are looking for in a Document Specialist: BS/BA in a technical/scientific field, technical writing, English or other relevant course of study Demonstrated experience with creating and modifying content in Adobe Creative Cloud (ie InDesign, Adobe Acrobat Pro, Photoshop), Canva, PowerPoint Excellent communication and organization skills Demonstrated experience interfacing with multiple parties and managing differences in feedback on material to achieve final product Familiarity with adherence to brand standards, creating instructor-led training modules, job aids, online tutorials, and other training materials Why Choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability Weekly payroll Expense reimbursement Online timecard approval Pay Scale: $60,203 $75,254 ( Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

Job Description The Quality Assurance Coordinator (QAC) position is focused on maintaining local compliance with State, Federal and BrightSpring Health requirements. The QAC provides leadership oversight to operations in meeting operational goals and ensure safety and satisfaction for individuals supported. The QAC will work with local programs within the region to develop, coordinate, implement, and monitor quality assurance initiatives and training programs to ensure the delivery of high-quality supports to the people and organizations we serve. The QAC plays an integral part in ensuring the operations meet regulatory and contractual compliance. The QAC will provide support to directors and administrators within the region. Responsibilities Conducts quality assurance and operational reviews, generate reports, and identify desirable corrective and preventative actions Creates and distributes schedule for quality assurance checks and full audits to ensure audits are completed on a consistent and timely basis Maintains current knowledge of area program regulatory and company requirements to ensure accurate quality assurance review Followscompany procedure and practice for completing various program quality assessment audits Completes Utilization Reviews on a consistent and timely basis Completes follow-up of Quality Assurance audits on a timely basis Requests and attends training to maintain current knowledge of area program regulatory and company requirements to ensure accurate quality assurance review Provides support to the service sites though assistance with quality/compliance regulations Conducts training and assisting with current and new processes Provides direction with regulatory compliance Interprets policy and procedure for operational staff and management Maintains required training per company guidelines and policy Completes other duties as assigned Qualifications HS Diploma/GED; Bachelor's degree preferred A combination of education and homecare experience may be substituted for a degree Experience conducting quality assurance and continuous improvement activities preferred One or more years' experience in quality management Excellent organizational and written skills Ability to maintain positive interpersonal communication with employees and customers

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Documentation Specialist Responsibilities: Strong editing and technical writing skills Strong attention to detail Strong ability to communicate effectively Must work well with cross-functional team members, including, Engineering, Quality, TS/MS Ability to receive direction and make applicable changes Excellent organizational and time management skills Intermediate skills with Microsoft Word Ability to work in fast-paced environment Minimum Qualifications: Minimum Education: Associate or Bachelor's degree Exceptional attention to detail and organizational skills Clear and professional communication skills Experience with document management and tracking systems Capable of multitasking and prioritizing independently Comfortable in fast-paced environments with frequent changes Onsite job requirement in Indianapolis, IN Preferred Qualifications: Experience with SOP redlines Previous experience with CMS system, such as Veeva Experience with Good Documentation Practice Exposure to TrackWise Working knowledge of Microsoft Teams and other collaborative tools Understanding of database structures and document control workflows For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range$59,951-$67,205 USD Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance. Medical, Dental & Vision insurances FSA, DCARE, Commuter Benefits Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Entry-level administrative, documentation support for working team, support activities of Business Analyst and Project Manager. Key Responsibilities: Maintain project tracking systems and update batch readiness tools Support administrative reporting and weekly metric submissions Collaborate with cross-functional teams to ensure documentation accuracy and alignment Anticipate and problem solve logistics and warehousing coordination Track material shipments and documentation for warehouse Goods Receipt Log manufacturing information in SAP Assist with deviation tracking and documentation closure follow-up Route GMP and manufacturing documents for approval using internal systems (e.g., Veeva Vault) Manage the lifecycle of controlled documents, ensuring up-to-date status and compliance Track document effectiveness and maintain metadata in appropriate systems Support the creation of reports, charts, and visual aids for communication Minimum Qualifications: Minimum Education: Bachelor's degree Preferred Education: BS in Professional Writing, Science, Engineering, Pharmacy, Pharmaceutical Sciences, Business or related field Exceptional attention to detail and organizational skills Clear and professional communication skills Experience with document management and tracking systems Capable of multitasking and prioritizing independently Comfortable in fast-paced environments with frequent changes Foundational project coordination or administrative experience Onsite job requirement in Indianapolis, IN Preferred Qualifications: Experience with GMP documentation processes Familiarity with Veeva Vault and document lifecycle systems Exposure to SAP, TrackWise, and Ariba platforms Working knowledge of Microsoft Teams and other collaborative tools Understanding of database structures and document control workflows For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer. National (US) Range$56,980-$67,205 USD Benefits Why Choose Verista? High growth potential and fast-paced organization with a people-focused culture Competitive pay plus performance-based incentive programs Company-paid Life, Short-Term, and Long-Term Disability Insurance. Medical, Dental & Vision insurances FSA, DCARE, Commuter Benefits Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 401(k) Retirement Plan (Employer Matching benefit) Paid Time Off (Rollover Option) and Holidays As Needed Sick Time Tuition Reimbursement Team Social Activities (We have fun!) Employee Recognition Employee Referral Program Paid Parental Leave and Bereavement Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com

Job DescriptionDescription: TRISTAR is seeking a Calibration Documentation Specialist to support its U.S. Navy customer at NSWC Crane. This position will support NSWC Crane's Calibration Measurements Requirements Summary (CMRS) work and will work directly with the customer on base. Key Responsibilities: Identify measurement parameters. Identify test methodology. Document traceability. Document uncertainty. Document prime system support equipment. Document calibration standards. At TRISTAR, we foster a collaborative and innovative environment that values professional growth and excellence. Join our team to contribute to impactful projects supporting national defense and technological advancement. We offer competitive benefits and opportunities for career development in a dynamic setting. Requirements: Must have prior experience calibrating equipment and/or tools. Must be able to work independently and problem solve. This position is on-site, and will require in-person meetings with the customer. Minimum 5 years of experience with Bachelor's degree only. Prior service experience, with relevant duty assignment, may be used as a substitute for education on a case-by-case basis. Prior U.S. Navy experience is preferred. Ability to obtain and maintain a government clearance. About TRISTAR: TRISTAR is a professional services company supporting U.S. Department of Defense programs. Our core competencies include Electronic Warfare, Enterprise Management, Full Spectrum Cybersecurity, Information Technology, Digital Transformation, Software Engineering and Development, Maritime Modernization and Engineering, and Technical Solutions. Founded in March 1995, TRISTAR has built an employee-focused collaborative environment enabling our team of professionals to create and deliver customized solutions to meet mission critical challenges. TRISTAR provides Equal Employment Opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Support other QA personnel with batch record reviews, material release, etc. Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily first shift (7 am to 4 pm) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing. Experience with Continuous improvement, Six Sigma, and/or Lean principles. Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs) Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: * Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. * Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. * Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. * Support other QA personnel with batch record reviews, material release, etc. * Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. * Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. * Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. * Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. * Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. * Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. * Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: * This position will support primarily first shift (7 am to 4 pm) with occasional weekend support, dependent on operations' needs. * Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) * Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. * Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. * Understanding of Good Documentation Practices (GDPs) and its criticality. * Excellent written and verbal communication skills. * General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: * Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs). * Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Warehouse Coordinator Quality Assurance Text DELIVER to 88300 to apply or check out more jobs at www.workat GEODIS.com! GEODIS specializes in unlocking business value in a complex world, ensuring seamless movement of goods worldwide. As a global third-party logistics provider (3PL), we power A Better Way to Deliver for the world's top brands and manufacturers. Fuel your career with GEODIS and discover endless growth opportunities. Look what you'll get by joining the GEODIS team! Get Good Money - Fair pay and some jobs come with bonus opportunities. Get the Right Job/Right Schedule - Part-time, full-time, seasonal - days, nights, weekends, and even gig work. We have the job and shift you want.* Get Paid Early - Pay day as early as you want. Access your earnings on demand. Get Free Healthcare - Access to telemedicine from day 1 at no cost. Other benefit options include healthcare, dental, vision at affordable costs after a short waiting period.* Get a Break - Paid holidays, time off, short-term disability and new parent leave are a few of the ways we support time away from work to take care of your life.* Stay Safe - We pride ourselves on a safe, clean and healthy work environment for everyone. Get a Voice - We are always asking our teammates to tell us how to make their experience working at GEODIS even better. Get Promoted - When you are ready to take the next step in your career, we will be there to support you. We promote about 10% of our warehouse workers each year. Get a Boost - Our GEODIS Compassion Fund makes one-time grants to teammates who have experienced unexpected catastrophes. Get Involved - Volunteer in your community or donate to the GEODIS Foundation or GEODIS Compassion Fund. Have Fun - Work with fun, supportive people just like you! Find Your Place - We value diversity and seek to provide an inclusive culture. Join an Employee Resource Group, participate in an international lunch, or celebrate your heritage to find your place of belonging. Find Your Future - Whether you are interested in the opportunity to work seasonally or looking to launch your career, GEODIS is the place! *Eligibility varies based on location, job, employee type, or length of service. What you will be doing: Establishes new items in the system to include measurements, SKUs, and pick front locations Communicates daily with customers by handling all quality issues, holds, releases, special projects and special requests Performs product function testing to customer standards Reviews product to ensure it is as described in comparison to our catalogue and/or internet, i.e., without cosmetic defects Requirements: High school diploma or GED (General Education Diploma) equivalency Minimum 1 to 3 years related experience and/or training Exposure to warehouse management systems PC literate with experience with Microsoft Outlook, Word and Excel Ability to apply common sense understanding to carry out instructions Ability to write reports, business correspondence and procedure manuals required Must also be able to effectively present information and respond to questions from customers Ability to define problems, collect data, establish facts and draw valid conclusions The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Job Duties as documented in this job description are considered “Essential Functions” and have been created by the standards of the Equal Employment Opportunity Commission (EEOC). The standards of the Americans with Disabilities Act (1990) require that employees be able to perform “Essential Functions” of the job with or without reasonable accommodation. Reasonable accommodations may be made to enable individuals with disabilities to perform the “Essential Functions”. More about GEODIS GEODIS is a global third-party logistics provider powering the supply chains of some of the top brands and manufacturers. Our legacy of excellence in supply chain solutions spans decades. Come find your future with us as we shape the future of logistics. Visit www.workat GEODIS.com to learn more.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra? Because we: Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers. Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways. Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health. This role: The Documentation Specialist is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign-out and sign-in of batch records from the Documentation Center. This role will also be responsible for assisting employees with correction resolution and handling the executed batch record documentation while going through the correction process. This role will also have secondary responsibilities assigned to help manage the work load in the Documentation Centers. These responsibilities could include, batch record review, support section review, non-batch related documentation review, controlled form reconciliation and audit trail review. He or she provides customer service to internal customers, as well as communicates effectively with all levels of the organization. The hours for this role are Monday-Friday 3:30p-11:30p. The responsibilities: Perform assigned tasks related to Veeva and ERP system for batches. Perform batch record review for GMP support sections produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. Reconcile discrepancies with documentation and/or electronic systems as appropriate. Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record. As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types. Manage the process of sign-out and sign-in of batch records. Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections. Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release. Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction. Qualification Associates degree or 2 years of similar relevant experience Experience with documentation and/or quality control systems preferred Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.) Physical / Safety Requirements: Occasionally required to lift and/or move objects (boxes, totes, etc.) weighing 25 pounds Duties may require nights and weekend work Use of hands and fingers to manipulate office equipment is required Position requires sitting for long hours but may involve walking or standing for periods of time In return, you'll be eligible for[1]: Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child Life Insurance Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program Paid Holidays Paid Time Off Paid Parental Leave and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits Voluntary Insurance Benefits Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more Onsite Campus Amenities Workout Facility Cafeteria Credit Union [1] Current benefit offerings are in effect through 12/31/25 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: **********************************

Our Labcorp site in Greenfield, IN, is currently recruiting for a Quality Auditor to support our toxicology team. We are looking for someone with at least 2 years in a GLP regulatory environment. Experience with the FDA's Good Laboratory Practices 21 CFR Part 58 is strongly preferred. Within the early development area: dose formulation, dose analysis, animal operations, clinical pathology and anatomic pathology operations support pre-clinical studies. We structure ourselves to deliver scientific expertise to our clients, collaborating closely with them to support the development of medicinal products through the drug development process and onto the market. This role supports the early development area as a Quality Auditor. You will perform quality audit reviews in pre-clinical studies. This position is at Greenfield, IN. facility at 671 South Meridian Road (This position is not remote). This position is not eligible for visa sponsorship. The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and where applicable for specific study types participate in internal facility/process and/or supplemental inspections, initiates, and reviews SOPs and prepares and delivers training in performance of audits. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role. Job Duties and Responsibilities: * Conduct, but not limited to protocol review, report/data audits, and internal facility/process inspections * Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution * Report on relevant quality metrics (for multiple topics/departments) and highlight trends * Peer review QA SOPs * Support operational liaison meetings representing QA function * Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed Minimum Education and Experience Requirements: * Minimum: Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience) * Experience may be substituted for education * 2 years in a GLP regulatory environment required and more GLP experience is a plus * Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance * Experienced GxP auditor * Able to interpret data and identify quality critical problems * Able to convey regulatory expectations Preferred Qualifications: * Experienced in process improvement and quality auditing * Demonstrated ability to apply critical thinking skills * Clear communication skills, including ability to provide clear feedback * Able to clearly articulate processes to provide training * Able to influence process improvement initiatives and offer solutions * Experience in an FDA 21 CFR Part 58 environment highly preferred Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.

What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary * Reports to Manager, Quality Assurance. * QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. * Authorized to inspect products to ensure the required quality standards are met. Responsibilities * Inspecting and sampling of product throughout the manufacturing process. * Establish and maintain quality control procedures. * Assist in determining types of tests to be performed as well as documentation and reporting requirements. * Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products. * Champion Quality, GMP compliance and EHS/Radiation Safety practices. * Develop and lead GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements. * Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems. * Assists in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations. * Responsible for the review and dispositioning of incoming raw materials and components. * Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements. Responsible for approval of minor Quality Events. * Ability to network across business and functional units to achieve positive outcomes. * Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product. * Understands technical/release product issues and evaluate their potential impact on product quality and compliance. * Provides ideas for continuous improvement of the GMP Quality Management System. * Escalates complex issues to management in a timely manner. * Prioritizes and ensures work is delivered in an efficient way. * Performs other job duties as assigned. Qualifications * Bachelor's degree in related field, or equivalent work experience, preferred. Advanced Degree may be preferred * 4-8 years' experience in related field, preferred What is expected of you and others at this level * Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects * May contribute to the development of policies and procedures * Works on complex projects of large scope * Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives * Completes work independently receives general guidance on new projects * Work reviewed for purpose of meeting objectives * May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. * Medical, dental and vision coverage * Paid time off plan * Health savings account (HSA) * 401k savings plan * Access to wages before pay day with my FlexPay * Flexible spending accounts (FSAs) * Short- and long-term disability coverage * Work-Life resources * Paid parental leave * Healthy lifestyle programs Application window anticipated to close: 2/1/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: * Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. * Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. * Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. * Support other QA personnel with batch record reviews, material release, etc. * Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. * Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. * Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. * Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. * Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. * Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. * Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: * This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations' needs. * Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) * Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. * Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. * Understanding of Good Documentation Practices (GDPs) and its criticality. * Excellent written and verbal communication skills. * General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: * Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs). * Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Job Description Our Quality, Risk and Compliance teams focus on maintaining compliance and auditing to mitigate risk for our operations. This keeps the company in compliance with State, Federal and overall company requirements, but most importantly to keep our clients safe and help them live their best life. If your passion is ensuring service quality and fostering compliance, read below and apply today! Responsibilities Conduct case file and record reviews for compliance and identifies opportunities for improvement or corrective actions and to ensure contractual performance expectations are met Submit weekly Quality Assurance reports in a timely manner to Project Director Present consistent feedback to management regarding areas that need improvement Ensure 100% of clients participate in the client satisfaction survey Ensure all clients receive a return call within 24 hours of calling and leaving a message Review quality assurance standards, study existing policies and procedures and interviews personnel and patients to evaluate effectiveness of quality assurance programs Creates, implements and monitors standard operating procedures Other duties as assigned Qualifications Associates degree in Human Services, education, psychology, sociology or related field required, Bachelors degree preferred Minimum two plus years related experience Demonstrate knowledge of quality assurance procedures and federal, state and local coalition laws and mandates Demonstrate knowledge of computers and knowledge of data management processes Demonstrate knowledge of eligibility determination processes and filing procedures

Our Labcorp site in Greenfield, IN, is currently recruiting for a Quality Auditor to support our toxicology team. We are looking for someone with at least 2 years in a GLP regulatory environment. Experience with the FDA's Good Laboratory Practices 21 CFR Part 58 is strongly preferred. Within the early development area: dose formulation, dose analysis, animal operations, clinical pathology and anatomic pathology operations support pre-clinical studies. We structure ourselves to deliver scientific expertise to our clients, collaborating closely with them to support the development of medicinal products through the drug development process and onto the market. This role supports the early development area as a Quality Auditor. You will perform quality audit reviews in pre-clinical studies. This position is at Greenfield, IN. facility at 671 South Meridian Road (This position is not remote). This position is not eligible for visa sponsorship. The individual in this role verifies compliance to standard operating procedures (SOPs) and regulations by performing study protocol, data, report, and where applicable for specific study types participate in internal facility/process and/or supplemental inspections, initiates, and reviews SOPs and prepares and delivers training in performance of audits. The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations e.g. Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) in the performance of their role. Job Duties and Responsibilities: - Conduct, but not limited to protocol review, report/data audits, and internal facility/process inspections - Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution - Report on relevant quality metrics (for multiple topics/departments) and highlight trends - Peer review QA SOPs - Support operational liaison meetings representing QA function - Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed Minimum Education and Experience Requirements: - Minimum: Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience) - Experience may be substituted for education - 2 years in a GLP regulatory environment required and more GLP experience is a plus - Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance - Experienced GxP auditor - Able to interpret data and identify quality critical problems - Able to convey regulatory expectations Preferred Qualifications: - Experienced in process improvement and quality auditing - Demonstrated ability to apply critical thinking skills - Clear communication skills, including ability to provide clear feedback - Able to clearly articulate processes to provide training - Able to influence process improvement initiatives and offer solutions - Experience in an FDA 21 CFR Part 58 environment highly preferred **Benefits:** Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here (************************************************************** **.** **Labcorp is proud to be an Equal Opportunity Employer:** Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. **We encourage all to apply** If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site (**************************************************** or contact us at Labcorp Accessibility. (Disability_*****************) For more information about how we collect and store your personal data, please see our Privacy Statement (************************************************* .

Schedule: Weekend Shift - Anticipated Friday - Monday What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. What a Principal Specialist, Quality Assurance contributes to Cardinal Health QA Principal Specialist is responsible for ensuring quality standards and procedures are followed and will oversee quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. Authorized to inspect products to ensure the required quality standards are met. Responsibilities * Inspecting and sampling of product throughout the manufacturing process. * Establish and maintain quality control procedures. * Assist in determining types of tests to be performed as well as documentation and reporting requirements. * Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products. * Champion Quality, GMP compliance and EHS/Radiation Safety practices. * Develop and lead GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements. * Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems. * Assists in the release of the final product in compliance with applicable regulations (FDA, EU, etc.) and marketing authorizations. * Responsible for the review and dispositioning of incoming raw materials and components. * Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements. Responsible for approval of minor Quality Events. * Ability to network across business and functional units to achieve positive outcomes. * Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product. * Understands technical/release product issues and evaluate their potential impact on product quality and compliance. * Provides ideas for continuous improvement of the GMP Quality Management System. * Escalates complex issues to management in a timely manner. * Prioritizes and ensures work is delivered in an efficient way. * Performs other job duties as assigned. Qualifications * Bachelor's degree in related field, or equivalent work experience, preferred. Advanced Degree may be preferred * 4-8 years' experience in related field, preferred Schedule: * Weekend Shift - Anticipated Friday through Monday * Potential to work 1st shift, to cover PTO of other analysts * Initial training for this role will be provided on 1st shift. What is expected of you and others at this level * Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects * May contribute to the development of policies and procedures * Works on complex projects of large scope * Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives * Completes work independently receives general guidance on new projects * Work reviewed for purpose of meeting objectives * May act as a mentor to less experienced colleagues Anticipated salary range: $79,700 - $113,800 Bonus eligible: No Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. * Medical, dental and vision coverage * Paid time off plan * Health savings account (HSA) * 401k savings plan * Access to wages before pay day with my FlexPay * Flexible spending accounts (FSAs) * Short- and long-term disability coverage * Work-Life resources * Paid parental leave * Healthy lifestyle programs Application window anticipated to close: 2/1/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Our Company ResCare Community Living Our Quality, Risk and Compliance teams focus on maintaining compliance and auditing to mitigate risk for our operations. This keeps the company in compliance with State, Federal and overall company requirements, but most importantly to keep our clients safe and help them live their best life. If your passion is ensuring service quality and fostering compliance, read below and apply today! Responsibilities Conduct case file and record reviews for compliance and identifies opportunities for improvement or corrective actions and to ensure contractual performance expectations are met Submit weekly Quality Assurance reports in a timely manner to Project Director Present consistent feedback to management regarding areas that need improvement Ensure 100% of clients participate in the client satisfaction survey Ensure all clients receive a return call within 24 hours of calling and leaving a message Review quality assurance standards, study existing policies and procedures and interviews personnel and patients to evaluate effectiveness of quality assurance programs Creates, implements and monitors standard operating procedures Other duties as assigned Qualifications Associates degree in Human Services, education, psychology, sociology or related field required, Bachelors degree preferred Minimum two plus years related experience Demonstrate knowledge of quality assurance procedures and federal, state and local coalition laws and mandates Demonstrate knowledge of computers and knowledge of data management processes Demonstrate knowledge of eligibility determination processes and filing procedures About our Line of Business ResCare Community Living, an affiliate of BrightSpring Health Services, has five decades of experience in the disability services field, providing support to individuals who need assistance with daily living due to an intellectual, developmental, or cognitive disability. We provide a comprehensive range of high-quality services, including: community living, adult host homes for adults regardless of disability, behavioral/mental health support, in-home pharmacy solutions, telecare and remote support, supported employment and training programs, and day programs. For more information, please visit ******************************* Follow us on Facebook and LinkedIn. Salary Range USD $20.00 - $22.00 / Hour