Quality assurance specialist jobs in Kokomo, IN

Details: Job Title: Global Supplier Quality Management Duration: 12+ Months Contract Pay Rate- $30 - $38 per hour on W2. Responsibilities: The Global Supplier Quality Management (GSQM) contractor is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of Client's new site expansions. The position ensures that Supply Chain & Affiliates organization provides central execution support in onboarding suppliers, materials, and GMP service providers in a timely manner to support project timelines with new site expansions. The contractor is responsible to partner, consult and interface with business partners to implement across networks and functions to meet business needs. The GSQM process focus is to provide a globally holistic process in which GMP supplier and GMP service provider's Supplier Quality Management activities are globally consistent, available, and executed by a central function to maintain patient safety, product quality, and technical elements at the highest standard and compliance. Key Objectives/Deliverables: The following activities will be performed according to established procedures, guidelines, forms and tools. These responsibilities are not intended to be all-inclusive nor are they all to be performed by one person: • Execute supplier quality management process in compliance with Global Quality Standards (GQS305, GQS301 & GQS307) in addition to others, as applicable • Assist procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing functions in identifying and managing material suppliers and GMP Service Providers. • Execute SAP and TW138 activities in the approved supplier list (ASL) process of suppliers and/or GMP service providers for Client's site expansions on behalf of the sites. Collaborate with SAP Business QA as needed. • Collaborate and communicate with manufacturing/affiliate sites across the networks (API / Manufacturing / Packaging / DPEM / APIEM / Devices) to ensure process execution is robust and effective and barriers are escalated. • Develop and communicate processes to manage the Global Supplier Quality Management (GSQM) process and related initiatives. • Provide support to ensure maintenance of the supplier quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, VeevaVault (QDocs), TrackWise. • Support execution of Certification Package Review Board and global certification packages for global SAP Manufacturing Plants (MPs) materials. • Partner with Global TS/MS to develop and execute the material risk control strategy (material risk, product acceptance risk, specification controls). • Provide input and support for supplier related change controls. This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities. Personal Development • Be continually aware of current industry trends and regulatory agency interpretation of GMP/cGMP and other relevant requirements, in particular, those related to the Supplier Management Programs. • Maintain good interpersonal and communication skills with business areas with emphasis on verbal and technical writing skills. • Complete required training and qualifications for the roles identified in the Learning Plan (LP). Qualifications: Associate's degree or other advanced education or training Excellent knowledge in manufacturing operations, quality, and supplier quality management is preferred. • Experienced in SAP, TrackWise, and Veeva QualityDocs is preferred. • Experienced in Change Management. • High ability in execution of MS Office basic suite (Teams, OneNote, OneDrive, Sharepoint, PowerPoint, Excel). • Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent interpersonal and oral presentation skills…. as well as strong written communication skills. • Creativity in strategy development and problem solving. • Ability to work independently and as part of a team with minimal supervision. • Ability to communicate, convince, train. Additional Skills/Preferences includes: • Five (5) years of minimum experience at manufacturing site within QA organization • Good knowledge of quality management; Supplier Quality Management; ISO and GMPs • PowerApps, PowerBI, Tableau experience • Knowledge of GQS, CQP, LQP Additional Information includes: • May require visits to Client's manufacturing sites. • Proficient English oral and written skills and experience

Job Title: Quality Assurance Engineer/ Advisor Compensation: $50/Hour W2 Onsite: 5 Days Each Week As a Quality Assurance Engineering - Advisor I, you will play a critical role in ensuring the highest standards of quality and performance for our software products. Your in-depth expertise will help shape the quality assurance processes and frameworks, ensuring that our solutions are reliable and meet the needs of our clients. You will work closely with development and product teams, identifying issues and implementing best practices to drive continuous improvements in our QA operations. This role offers the opportunity to make a significant impact on the quality of our products and the overall user experience. What you'll do: Lead the execution of detailed quality assurance testing for complex software products. Develop and implement comprehensive test strategies and plans. Identify, report, and track software defects to resolution. Collaborate with development and product teams to improve quality practices. Mentor and guide junior QA team members to ensure adherence to best practices. Participate in continuous improvement initiatives within the QA team. Responsibilities listed are not intended to be all-inclusive and may be modified as necessary. Experience you'll need to have: 6+ years of experience in software quality assurance 3+ years of experience in automation testing 3+ years of experience in performance testing 3+ years of experience in Agile methodologies 6+ years of an equivalent combination of educational background, related experience, and/or military experience Experience that would be great to have: Experience with automated testing tools Knowledge of continuous integration and continuous deployment (CI/CD) tools Familiarity with security testing practices Understanding of software development lifecycles Certification in software testing methodologies

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: 2/1/2026 *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. 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

Bastian Solutions is seeking a Software QA Professional to create and execute test plans on custom developed software. This person will work in either Louisville, KY or the new headquarters in Noblesville, IN. The Quality Assurance team is the primary proponent for all quality assurance programs affecting Bastian Software Solutions (BSS). The QA Professional is integral in supporting the QA group to perform quality testing for existing, modified, and custom software to be implemented for BSS's clients, as well as leading other process improvement initiatives. This person manages the development of complete test plans as well as conducts quality, stress, regression and load tests for software programs developed at BSS and Bastian India. The QA Professional will oversee or perform complete validation ensuring that all software modules meet functional specifications, software design documents, and end user requirements. Job Functions Database Analysis. Performs backend database validation in Microsoft SQL Server or Oracle, including validating queries, updates, stored procedures, maintenance plans, data migration, and triggers. Requirements Analysis. Analyzes project requirements from specifications, maps test cases to requirements and designs test coverage plan. Test Case Management. Develops, documents, and maintains functional test cases and other test artifacts like test data, data validation, and automated scripts to validate all project requirements are fulfilled. Test Plan Management. Holds and facilitates test plan/case reviews with cross-functional team members. Creates and executes User Acceptance Test plans with project team. Software Testing. Executes and evaluates manual and automated test cases and records test results. Issue Management. Identifies any potential quality issues per defined process and escalates high priority quality issues immediately to project team and management. Defect Management. Isolates, replicates, documents, and reports root cause defects and verifies defect fixes. Environment Management. Creates and maintains virtual machines for the customers whose programs are being tested. The analyst is responsible for maintaining synchronized environments and documenting changes. Software Installation. Installs software promotes on test environments, performs needed configurations, and ensures that the program performs correctly. When called upon, may also help project managers to do the same thing in production environments. Software Configuration. Understands the available configurations and is able to set and test appropriately for the project and test case being performed. Travel Requirements 15% overnight travel (Travel expenses paid by Bastian Solutions) Must maintain a valid driver's license Preferred Skills and Required Qualifications Must be eligible to work in the USA long term without sponsorship. Bachelor's Degree in Computer Science, Engineering, or related field. 2+ years of relevant QA technical experience Ability to write and execute SQL Queries Ability to manipulate data in a SQL database Previous experience writing test cases Troubleshooting knowledge with custom software Excellent problem solving capability (business and technical) Enjoys working in the software development and automation technology field (very computer literate) Strong quality control, quality assurance and computer skills including: TFS, manual and automated testing tools, and various Databases (SQL Server and Oracle). To learn more about us, click the following link - ******************************************* About Bastian Bastian Solutions, a Toyota Advanced Logistics company, is an independent material handling and robotics system integrator providing automated solutions for distribution, manufacturing, and order fulfillment centers around the world. Our team specializes in consulting, system design, project management, maintenance, and installation, while sourcing the best equipment and automation technology. We take great pride in providing exceptional service and flexibility to our customers. In addition to exciting work at a growing company, we offer the following benefits: Health, Dental, and Vision Insurance 401(k) Retirement Plan with a company match Vacation/Holiday Pay Tuition Reimbursement Flexible Work Schedules Volunteer Work Professional Associations, Conferences and Subscriptions Company Meetings & Events Bastian Solutions does not work outside recruiting agencies. No solicitation phone calls please.

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)

Description & Requirements Maximus is currently hiring a remote Haitian Creole Bilingual Quality Assurance Administratorto support the Florida Healthy Kids (FL HK) program operations and ensure compliance with established standards and Florida healthcare policies. In this role, you will be responsible for monitoring phone calls and completing back-office quality reviews to determine whether employees are meeting required performance, quality, and compliance standards. You will also participate in special projects and program initiatives as needed and serve as backup support for the call center during periods of high volume or operational need. The ideal candidate demonstrates strong attention to detail, excellent critical thinking and analytical skills, and the ability to accurately interpret and apply Florida healthcare policies. This position requires a high level of organization, consistency, and accountability in a remote work environment. Essential Duties and Responsibilities: - Provide assistance to program clients with completion of paperwork and obtains employment verification documentation. - Support case managers to obtain attendance documentation. - Scan and log all client documentation in an accurate and timely manner. - Ensure activities and processes are in compliance with both company QA standards and applicable contractual standards. - Enter, transcribe, record, store, or maintain information in written, electronic and magnetic form relating to services, processes and quality systems. - Coordinate review activities as assigned by management. - Perform general office duties such as filing, copying, faxing and mail. - Perform other duties as may be assigned by management. Minimum Requirements - High school diploma or equivalent with 0 - 2 years of experience. - Florida residency preferred. - Florida Healthy Kids Program experience preferred. - Bilingual proficiency in both English and Haitian Creole required. Home Office Requirements: - Desktop or Laptop that runs Windows, Mac, or Linux (no Chromebooks or tablets). - OS for Windows - Current release of Windows 10 or newer. - OS for Mac - Big Sur (11.0.1+); MacOS (10.14) or newer. - OS for Linux - Ubuntu (18.04). - Connectivity to the internet via either Wi-Fi or RJ-45 connection for wired network connection to home router (no mobile hotspots). - Internet speed of 25mbps or higher required (you can test this by going to ******************* - USB plug and play wired headset with a microphone (no Bluetooth, AirPods or wireless gaming headsets). - Must currently and permanently reside in the Continental US. - Must have a camera EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency Maximus compensation is based on various factors including but not limited to job location, a candidate's education, training, experience, expected quality and quantity of work, required travel (if any), external market and internal value analysis including seniority and merit systems, as well as internal pay alignment. Annual salary is just one component of Maximus's total compensation package. Other rewards may include short- and long-term incentives as well as program-specific awards. Additionally, Maximus provides a variety of benefits to employees, including health insurance coverage, life and disability insurance, a retirement savings plan, paid holidays and paid time off. Compensation ranges may differ based on contract value but will be commensurate with job duties and relevant work experience. An applicant's salary history will not be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at **************************. Minimum Salary $ 17.00 Maximum Salary $ 18.50

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 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

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 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 Title: Quality Assurance Associate GENERAL JOB DESCRIPTION Were looking for Quality Assurance Associates in our Fulfillment Center to inspect and ensure that all ingredients and all items in boxes meet required quality standards. MAJOR DUTIES AND RESPONSIBILITIES Objectives of this Role Assist Specialist with Gold Standard and table set up Audit tables on a continuous basis (each table at least once per hour) Audit bins of finished product continuously (each table at least once per hour, each automated prep at least once every 15 minutes) Document all audits in Quality Tool Suite Notify Specialist and Quality Auditor of any issues Attend monthly refresher trainings with Quality team Speak with Quality during start up communications Assist Specialist with calling the line and ensuring accuracy Audit pack lines on a continuous basis (at least twice per hour) Audit finished boxes continuously (at least three boxes per hour) Document all audits in Quality Tool Suite Notify Specialist and Quality Auditor of any issues Attend monthly refresher trainings with Quality team Speak with Quality during start up communications QUALIFICATIONS FOR THE JOB Skills and Requirements Clear and concise communicator, verbal and written. Ability to work calmly and effectively under pressure. Ability to work in fast-paced, deadline-oriented environment. Flexible availability; we work night and weekend shifts. Must be able to lift up to 49 pounds repetitively with or without reasonable accommodation Must be able to handle exposure to temperatures that range from freezing to sub-freezing (coolers, freezers, etc.) Must be able to stand/walk for up to 10-12 hours with or without reasonable accommodation Must be willing and able to frequently push, pull, squat, bend, and reach with or without reasonable accommodation Experience / Education 1-2 years experience in a food production or warehouse environment

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: 2/1/2026 *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.

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)

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. Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world. Job Summary: This role provides essential Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners. Job Responsibilities: Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control. Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards. Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods. Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement. Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers. Develop, implement, and maintain quality agreements with external manufacturing organizations. Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs). Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites. Mentor and provide technical guidance to junior QA associates. Job Qualifications: Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Pharmacy, Chemical Engineering) or related field. Minimum of 5-8 years (Senior Associate) or 8+ years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and external supply. In-depth knowledge of cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements. Proven experience in auditing external manufacturing sites. Strong understanding of API manufacturing processes, analytical techniques, and quality control principles. Demonstrated ability to make sound quality decisions and effectively communicate complex technical and quality information to diverse audiences. Excellent problem-solving, analytical, and critical thinking skills. Ability to work independently and as part of a team in a fast-paced, dynamic environment. Proficiency in quality management systems (e.g., TrackWise, Veeva). Willingness to travel domestically and internationally to external manufacturing sites as required. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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 Company ResCare Community Living 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 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 $21.10 / Hour