Quality assurance specialist jobs in Muncie, 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.

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. Position Brand Description: The QA Representative - Floor Support team member provides daily oversight, assistance, and guidance to issues within Parenteral Visual Inspection such as deviation investigations, change control proposals, procedure / batch record revisions, validations, batch disposition, commissioning, and qualification activities. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. Responsibilities: Lead, mentor, and coach Operations and support personnel on quality matters. Ensure regular presence in visual inspection operational areas to monitor GMP programs and quality systems. Collaborate cross-functionally as a core member of a manufacturing process team. Assess and triage deviations that occur within the local process team. Work with Lilly support groups and external partners to resolve or provide advice on product related issues Participate in self-led inspections and provide support during internal / external regulatory inspections. Effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations, procedures, technical studies, validation protocols, change controls, and engineering documents) Support project and process improvement initiatives for plant Process Teams. Basic Requirements: Bachelor's degree or equivalent (Science or Engineering related degree preferred). Strong oral and written communication and interpersonal skills Demonstrated decision making and problem-solving skills Technical writing skills Additional Skills/Preferences: Previous experience in/with GMP production environments or Quality Control Laboratories Knowledge and understanding of manufacturing processes and Quality Systems Proven ability to work independently or as part of a team to resolve an issue Strong attention to detail Additional Information: Travel: Less than 10% Shift information: Day shift Monday-Friday. May be required to respond to operational issues outside of core business hours / days. Overtime may be required Position location: LTC-South Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position. May be subject to Post Offer Exam 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 $66,000 - $116,600 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

Working closely with the QA Operations Supervisor and IQC Manager. QA Specialist 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 Specialist, IQC will need to provide support with identifying operational and quality gaps. The Quality Assurance Specialist, IQC will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Specialist, IQC 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 Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Specialist, IQC 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 verification of incoming pharmaceutical shipments and contents against purchase orders, materials specifications and receiving in line with INCOG SOP's. Review and approve documentation, including but not limited to logbooks, material packets, material specifications, packing lists, work orders, procedures, etc. · Collaborate with Supply Chain, IQC, and Operations team and lead or provide support with investigations to resolve inventory and material, consumables, and component related deviations. · Support other QA personnel from Operations as necessary with batch record reviews, corrections, floor operations, etc. · Inspect products for damage, discrepancies, or expired items and report any issues to the Warehouse Manager. · Prioritize and coordinate his/her time in balancing 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. · Provide Quality Assurance oversight into the picking of product Bill of Materials (BOM). · Assist Supply Chain Management with Critical Alarm reporting with freezer farm or incubator alarms. · Perform both provisional and full release of materials. · Dispose of Filled Inspected Product (FIP) rejects following batch disposition. · 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. · Assist Operations with incoming and outgoing Material Transfer counts. · 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. · Provide Quality Assurance oversight with Supply Chain inventory cycle counts and investigate any discrepancy. · Ability to manage multiple projects in a fast-paced environment. · Assist in maintaining records for regulatory inspections and audits. Special Job Requirements: · This position will support primarily first shift (7:00 am - 3:30 pm) with occasional weekend support, dependent on operations' needs. · Bachelor's Degree required or equivalent; degree preferred to be in Logistics, Supply Chain, Management, Biology or Chemistry · Minimum of 4 years with experience working as Quality in a GMP Manufacturing environment, Raw Material/ Component/Consumable release and/or as an Operator within a Pharmaceutical Supply Chain/Warehouse environment. · Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. · Understanding of Good Documentation Practices (GDPs) and its criticality. · Ability to obtain Powered Industrial Lift Certification. · Excellent written and verbal communication skills. · Ability to lift 50 lbs. · General computer skills evidenced by hands-on work with inventory management systems; and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: · Hands-on experience with aseptic manufacturing, inspecting finished products, and supply chain or warehousing. · 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.

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

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Quality assurance associate will have responsibility for reviewing incoming complaints for thoroughness and appropriateness in accordance with policies and procedures. Review incoming CFs (complaints) for thoroughness of required information, appropriate complaint type selection, timely submission, and appropriate wording for a regulated environment. Accept or reject incoming CFs (complaints), based on above criteria. Communicate with CF (complaint) submitters regarding missing information, inaccurate complaint type selection, untimely submission, or inappropriate wording for a regulated environment. Monitor draft complaints for timely submission. Submit returned material authorization (RMA) requests to vendor for credit for defective product reported through complaints. Follow-up with vendor regarding requested RMAs. Track number of accepted / rejected complaints per day, reasons for rejections, and other pertinent data. Participate in visual management meeting for complaint handling team. Complete assigned training in a timely manner. Cross-train with Manager and peers for any other assignments as applicable. Qualifications 1-2 years of experience. Detail oriented, proactive, attention to accuracy, excellent customer service both internally and externally, good documentation skills Preferred background: Regulated industry complaint handling experience preferred. Required Education: Bachelor's degree, with degree in science or engineering preferred, but not required Technical/Software tools used: Outlook, Master Control, Excel files, Global CAPA Top 5 characteristics to be successful in this role: Detail-oriented, accurate, focused, good documentation skills, business professional How is performance measured Timeliness of disposition of incoming complaints; quality of accepted complaints. Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you. Kind Regards, Harris Kaushik Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (650)-399-0891 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

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

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.

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

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.

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_** The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities. **_Responsibilities_** + Lead the efforts within Cardinal Health to collect substance information on products and raw materials from suppliers + Load and extract product systematic data on substances within Cardinal Health Master Data systems + Review and evaluate received questionnaire forms for completeness and applicability + Coordinate with Supplier, Sourcing, Quality, Regulatory and Manufacturing teams to obtain information necessary to complete assigned tasks + Identify and quantify risk, communicate results effectively to management + Support management of QRA policies governing product quality data + Identify quality and regulatory related issues within current processes, investigate and provide recommendations + Interact with cross-functional business partners (Customers, Operations, Sourcing, Regulatory, Manufacturing Quality, field QRA, etc.) to assist in execution of the current Medical Distribution Quality Plan. + Responsible for deployment of policies and programs to minimize risk and enable compliant business operations for Cardinal Health + Demonstrates working knowledge of applicable laws and regulatory concepts utilized to manage risk + Supports development of programs, policies and procedures using knowledge of regulatory requirements and technologies + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains a broad knowledge of the technical disciplines in own functional area; applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise; influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes; in light of culture and diversity **_Qualifications_** + Bachelor's degree preferred + 1-3 years experience preferred + Knowledge of Regulated Substances regulations such as EU MDR, REACH, RoHS, WEE, POP and California Proposition 65 preferred + Distribution Operations processes (Medical and Pharmaceutical) preferred + Excellent verbal, written, computer, SAP, and interpersonal skills required + Excellent influencing skills + Must be able to multitask and work with competing priorities **_What is expected of you and others at this level_** + Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces + Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and best practices in a manner that ensures exceptional performance and results + Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications + Encourages informed risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources + Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity implications **Anticipated hourly range:** $26.90 per hour - $36.90 per hour **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:** 12/07/2025 *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 (***************************************************************************************************************************

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. The Associate - CPQA-ARC Quality Assurance (QA) Complaint Investigator (hereafter referred to as Associate - QA) is responsible for evaluating product complaint record information to determine the: validity of the complaint; complaint level; complaint category(ies); investigation site and; where appropriate, complaint conclusions. The Associate - QA is responsible for performing batch number and/or product retrieval activities per applicable local procedures. The Associate - QA may also be responsible for performing and/or verifying visual and/or functional evaluations of returned complaint product and determining the appropriate triage of the returned product. The Associate - QA is responsible for determining any follow-up information required from the reporter or related contacts that may assist with the triage of the complaint record. Responsibilities: • Assess product complaint information, designate an appropriate complaint level, and assign suitable complaint and/or analysis category(ies). • Determine the need for additional investigation and forward product complaint records and/or complaint product to the proper manufacturing or packaging quality unit for further investigation, as required. • Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from the reporter and/or related parties. • Determine the need for the product complaint return and perform complaint product retrieval actions, per local procedures. • Perform visual and/or functional analysis of returned complaint product, per local procedures. • Assess product complaint information and the results of the returned complaint product, including impact on: complaint level; complaint category(ies); investigating site; and additional investigation requirements. • Respond to the customer with educational information, as applicable, during customer follow up activities (e.g., request for batch number and/or product complaint sample). • Forward process complaints and related activities in adherence to established timeframes • Apply cGMP principles in all phases of the product complaint investigation (e.g., data documentation). • Perform CPQA laboratory related tasks (e.g. returned product check-in, product shipping, waste drum disposal), as applicable. • Build and maintain working relationships with The Lilly Answers Center and other affiliates associated with the Americas Regional Center, as well as manufacturing and packaging sites, global pharmaceutical investigations team, global patient safety, and other regional complaint centers. • Serve as a subject matter expert (SME) for applicable CPQA-ARC procedures and work instructions. • Participate in departmental process improvement activities. • Conduct training and peer monitoring, as applicable. • Maintain appropriate training qualification to perform complaint investigation activities. Basic Requirements: • A bachelor's degree in health science related field (e.g., pharmacy, nursing, chemistry, biology, or engineering) • Minimum 2 years of work experience post degree Additional Preferences: • A health care professional background (e.g., degree in pharmacy or nursing). • Solid collaboration, teamwork and interpersonal skills. • Strong verbal and written communication skills in English. • Attention to detail. • Self-management / motivated. • Ability to multi-task. • Above average computer literacy and computer skills. Specific training for complaint handling software will be provided. • Strong curiosity skills with the ability to question/identify issues & work to resolution. • Strong critical thinking/problem solving skills with an ability to apply rationale. • Ability to mentor/train others - share learning. • Ability to safely work in a laboratory environment (e.g. wear appropriate personal protection, potential for exposure to allergens, able to lift 20 pounds). • Demonstrated knowledge of related quality systems • Experience within the field of devices or parenteral products. • Regulated industry experience (e.g., exposure to cGMPs), preferably in quality organizations Additional Information: • The position does not require shift work or frequent traveling. • Responsibility for after-hours and company shutdown coverage may be required. • The Associate - QA will work in an office and/or laboratory environment. • The Associate - QA may work in a laboratory environment with potential exposure to known allergens, oncolytics, and the contents of returned complaint product. • This position is based in Indianapolis, IN, requiring time onsite. 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 - $148,500 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

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. Job Description Quality assurance associate will have responsibility for reviewing incoming complaints for thoroughness and appropriateness in accordance with policies and procedures. Review incoming CFs (complaints) for thoroughness of required information, appropriate complaint type selection, timely submission, and appropriate wording for a regulated environment. Accept or reject incoming CFs (complaints), based on above criteria. Communicate with CF (complaint) submitters regarding missing information, inaccurate complaint type selection, untimely submission, or inappropriate wording for a regulated environment. Monitor draft complaints for timely submission. Submit returned material authorization (RMA) requests to vendor for credit for defective product reported through complaints. Follow-up with vendor regarding requested RMAs. Track number of accepted / rejected complaints per day, reasons for rejections, and other pertinent data. Participate in visual management meeting for complaint handling team. Complete assigned training in a timely manner. Cross-train with Manager and peers for any other assignments as applicable. Qualifications 1-2 years of experience. Detail oriented, proactive, attention to accuracy, excellent customer service both internally and externally, good documentation skills Preferred background: Regulated industry complaint handling experience preferred. Required Education: Bachelor's degree, with degree in science or engineering preferred, but not required Technical/Software tools used: Outlook, Master Control, Excel files, Global CAPA Top 5 characteristics to be successful in this role: Detail-oriented, accurate, focused, good documentation skills, business professional How is performance measured Timeliness of disposition of incoming complaints; quality of accepted complaints. Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus. Thank you. Kind Regards, Harris Kaushik Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO DIRECT # - (650)-399-0891 Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

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

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.

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.

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