Quality assurance specialist jobs in Indiana

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

Mission The Supplier Quality Specialist is responsible for executing activities related to the qualification and certification of suppliers, ensuring their compliance with product and process regulatory requirements, quality standards, and customer expectations. This role supports the achievement of high-quality service delivery by effectively implementing the Quality Management System, contributing to cross-functional processes, and providing expertise in supplier quality management. Key Responsibilities 1. Supplier Quality Management Deploy robust, systematic processes for supplier qualification and certification. Serve as a single point of contact for quality issues related to suppliers. Collaborate with Supply Chain, Operations, and Commercial teams to provide technical feedback and reports. 2. Supplier Quality Operational Processes Execute quality specifications for materials, products, and services supplied. Participate in new product launches and validate supplier capabilities. Monitor supplier process changes and apply methodologies like PPAP. Conduct root cause analyses to resolve quality issues. 3. Supplier Qualification Process Management Develop procedures and questionnaires for supplier qualification and certification. Support Procurement in supplier selection, assessing process capabilities and risk. 4. Supplier Quality Audit Management Coordinate and perform supplier audits to evaluate service quality and compliance. Follow up on audit actions and status of supplier certification. 5. Monitoring and Reporting Analyze complaint trends, product quality data, and supplier performance. Propose and implement continuous improvement actions and KPIs. 6. Guideline, Procedures and Document Management Maintain a supplier repository and related documentation. Ensure a consistent approach to supplier issues, aligned with QMS standards. Review and update procedures with cross-functional input. 7. Relationship Management Act as a liaison with key internal teams and external partners. Drive awareness and training on supplier quality topics to ensure alignment and compliance. Skills & Experience Bachelor's degree in engineering or related field 3-7 max years of experience in a supplier quality role Excellent written and verbal communication skills Open to industry Why should you work with us? Brand new facility located in the Fishers Life Sciences and Innovation Park Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend 100% employer paid Dental and Vision benefits Modern space with brand new technology, climate-controlled production floor Opportunity for growth, development, and advancement 3 weeks of PTO, 10 paid holidays, 8 sick days Competitive salary

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

Job Title: Special Process Auditor - SPTT Company: AISIN World Corp. of America Department: Purchasing, SPTT Responsibilities The incumbent is expected to perform the following functions that the company has determined are essential to this position: Communicate and partner with Aisin Purchasing, Quality, Supplier Quality, SED/SPTT, Design, and Production, groups to implement supplier special process audits. Manage and lead supplier audit activities based on Aisin Level I and Level II Special Process requirements. Track the status of each special process audit and develop improvement plans if necessary. Establish audit frequency and manage accordingly. Visit assigned suppliers regularly and communicate results to AWA and affected NAP Track supplier special process performance metrics regionally (North America, Canada, and or Mexico) Other tasks and duties as assigned. Required Skills and Abilities Essential Skills and Experience: 3-5 years' experience in a manufacturing environment in a quality or process/manufacturing technician or engineering role Working knowledge of ISO9001 and/or IATF16949 quality systems standards Understand Microsoft Office applications Ability to review the manufacturing process, analyze activities, and develop potential actions for improvement of manufacturing process and quality systems. Ability to read, understand and interpret drawings and engineering specifications Ability to develop training materials and provide training where required for suppliers Beneficial Skills and Experience Bilingual English and Japanese Experience with welding applications Experience with heat treatment applications Experience with adhesion applications Knowledge of AIAG CQI Process Assessments Skilled in Microsoft Software Education/Training/Certifications Associate degree (or equivalent experience) preferably in a math or engineering discipline Bachelor of Science degree in Engineering field preferred ASQ certification as Technician, Engineer, Auditor, and/or NSPE as Professional Engineer highly desirable Travel Requirements Approximately 50 % Must be willing and available to travel to such locations and with such frequency as is necessary and desirable to meet business needs. Work Environment Requirements With reasonable accommodation: Must be able to operate a personal computer, telephone, and other office equipment. Must perform job duties onsite, when necessary, except those duties that are customarily or by their nature performed offsite (for example, offsite customer visits). Must be able to work effectively in a fast-paced environment. Must be able to work on multiple assignments at once, and complete assignments within deadline and budget (if applicable) with satisfactory quality. Must be able to operate as an effective team member. Must be committed to a high standard of safety and be willing and able to comply with all safety laws and all company safety policies. Attendance/Work Hour Requirements Must maintain an acceptable attendance record. Must be willing and available to work weekends and holidays as necessary and desirable to meet business needs.

Hubot - Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Quality Assurance Auditor for immediate addition to our fast growing team. Job Description: The Quality Assurance Auditor will perform quality control checks per specifications, identify non-conforming products and perform root cause analysis. Responsibilities: Review of production line parameters and performance for adherence to Company Standard Operating Procedures, Quality Guidelines and Facility Procedures Testing samples for physical adherence to Quality Specifications for Finished Product Pull and identify product samples for the internal lab, retain, and external customers Responsible for work area cleanliness and organization Instrument Calibration Verification Ability to follow detailed instructions Must be flexible to work 8-10 hour days Able to lift a minimum of 30 lbs Ability to climb stairs/ladder Ability to work in a Cleanroom environment and lab Must have good communication skills, both verbal and written Able to work safely, carefully and follow strict guidelines Detail oriented Other duties as assigned Education and/or Experience: Education: High School or higher, excellent mathematics and problems solving skills preferred 2-3 + years hands-on experience with quality systems and checks Microsoft (Word/Excel) skills Math skills Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Thank you for your interest and consideration of a career with Hubot - Tri Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

**Responsibilities:** + Assist Quality Assurance (QA) personnel with GIS and administrative tasks of the Quality Assurance program for the Mapping & Records department. + Post simple GIS sessions, run GIS reports, assist with GIS resets, complete Quality Assurance work order packet reviews and close out, create IT Incident tickets, and support administrative Quality Assurance tasks. + Assist Quality Assurance (QA) staff with administrative tasks of the QA program for the Mapping & Records Department. + Update the Access database with the required data. Process work order packets: receipt, assign, update logs, organize and maintain files in department, pull work order packets and send completed packets to archive. + Assist with creating IT incident tickets as needed. **Skills:** + GIS experience + Detail oriented + Interpersonal/communication skills + Organization skills + Computer skills + Able to work independently. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

"Together We Make Life Better". Our quality engineering, sustainable solutions and safety record inspire everything we do. Our diverse and inclusive workforce allows all employees to feel valued and safe to give their opinions and improve our company. Tata Consulting Engineers USA, LLC, (TCE), is a multi-disciplinary engineering organization offering a full range of integrated engineering design, project support, procurement and construction management services to the energy and chemicals industries. Position Summary Quality Assurance Construction Coordinator to implement quality assurance procedures for capital and expense projects managed by the customer's Project/Construction Focal point, and will lead the overall Quality Assurance program for the Construction Management team. Responsibilities Assess current quality management systems and practices, identify gaps, and recommend closure action plans. Work with stakeholders to effectively implement quality management system elements. Development and maintenance of local and regional documents that support and compliment global quality specifications and guidelines. Train and coach Construction Management personnel on quality best practices and requirements. Network with global colleagues to stay current on incidents, improvements and best practices. Implementation standardization and measurement of the effectiveness of quality systems and work processes to ensure that the Global Construction Quality strategies are successfully maintained. Leads or participates in Quality related unplanned event investigations and ensures that actions effectively address root causes. Perform internal audits to assure conformance to work processes. Ensure that the required contractor Quality Control procedures are properly implemented and that the constructed facilities comply with the related requirements, codes, and specifications. Significant Safety visibility and activity, providing support to the Construction Manager. Verify the contractors' implementation of their Project QC plan, identify deficiencies. Work with construction team to initiate any required 'Request For Variance' and/or MOC. Ensure that installation is according to customer specifications and contract drawings. Complete Non-Conformance Reports and monitor all NCR's for status and to closure. Communicate nonconforming issues of customer procured equipment, tanks, vessels, etc. to the Regional Quality Manager. Lead process to obtain, review, and approve contractor provided quality plans, inspection and latest plans. Participate in lesson learned analysis. Work with Discipline Focal Points and implement improvement actions. Request metrics to the Discipline Focal Points. Qualifications Familiar with or previous experience with construction documents such as isometrics, P&ID's, Owner piping codes, civil- underground, and structural steel drawings, rotating equipment and vessel drawings, electrical single line diagrams and architectural drawings, quality best practices, safety standards, ASME, API, AWS, and similar codes of construction. Multi discipline experience preferred including civil concrete and structural steel, mechanical/ piping, vessels, reactors, rotating equipment, electrical equipment such as transformers, motor control centers, termination of motors, power distribution Applicant must be willing at times to cover off hour work (night, weekend, or overtime) as applicable. EEO Statement Tata Consulting Engineers USA, LLC ("TCE") is an equal opportunity and affirmative action employer committed to promoting diversity, equity, and inclusion in our workplace. We do not discriminate on the basis of race/ethnicity, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, veteran's status, or any other characteristic protected by local, state, or federal laws, rules, or regulations. In compliance with federal law, all candidates hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form after acceptance of a formal TCE offer letter through our onboarding system. Fraud Alert Please be aware that there have been instances of fraudulent job offers being made in the name of TCE by unauthorized individuals or organizations. We want to make it clear that TCE will never ask for any type of payment information during our interview process. Please be advised during our company transition, all email communications from TCE will come from our business email addresses, which end in '@tatconsultingengineers.com'. If you receive any suspicious job-related emails from any other domain, please do not respond to them and disregard any requests for personal or financial information. If you have any concerns about the legitimacy of a job offer or communication, please contact us through our website at tataconsultingengineers.com

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

Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is noticed and valued every day. Mailroom Quality Assurance Coordinator Location: Onsite in Erlanger, KY Pay: $16 an hour with shift differential, which may be below your state's minimum wage. Please take this into consideration when applying. Schedule: Monday-Friday 3:00pm-11:00pm About the Mailroom Quality Assurance Coordinator role: We are seeking a dedicated and detail-oriented Mailroom Quality Assurance Coordinator to support our quality processes and help ensure client satisfaction and operational excellence. The ideal candidate is highly organized, has a strong understanding of standard operating procedures, and thrives in a fast-paced production environment. What You'll Do: • Ensure all print and mail tasks are executed in compliance with established Standard Operating Procedures (SOPs). • Reprint and process damaged packages to ensure timely and accurate delivery to clients • Perform random quality inspections on printed and packaged materials to verify compliance with quality standards. • Maintain and verify the balance check log, ensuring all printed checks are accounted for and documented appropriately. • Collaborate with team members to meet daily production goals and client service-level agreements. • Report and document any errors, discrepancies, or equipment issues promptly. What We're Looking For: Excellent oral and written communication skills Must be able to multi-task while maintaining accuracy Attention to detail Proficient math skills Must be at least 18 years old and able to pass a criminal background check and drug screening High school diploma or GED required Comfortable using Microsoft Office (Word, Outlook, Excel) Dependable and able to work full-time onsite Why You'll Love It Here: Full-time, stable employment (up to 40 hours/week) Benefits start day one - health, dental, vision, and more Growth and career advancement opportunities Friendly, professional work environment Pay Transparency Laws in some locations require disclosure of compensation and/or benefits-related information. For this position, actual salaries will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance. In addition to base pay, this position, based on business need, may be eligible for a bonus or incentive. In addition, Conduent provides a variety of benefits to employees including health insurance coverage, voluntary dental and vision programs, life and disability insurance, a retirement savings plan, paid holidays, and paid time off (PTO) or vacation and/or sick time. The estimated salary range for this role is $16 an hour. Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law. For US applicants: People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded: click here to access or download the form. Complete the form and then email it as an attachment to ...@conduent.com. You may also click here to access Conduent's ADAAA Accommodation Policy.

Embrace the opportunity to positively change someone's life! Join our Indiana team as a Quality Assurance Coordinator! Dungarvin is hiring a QA Coordinator. In this role you will be responsible for ensuring high-quality services. This includes program oversight, conducting site visits, independent Electronic Health Record (EHR) data reviews, and follow through with Operations. Why This Role: Personal fulfillment, meaningful career, and the chance to make a difference. Build meaningful bonds with persons served and their families. Further develop your leadership experience in the social service field Varied day-to-day experiences; no two days are the same. Schedule: Full-time with potential travel throughout the state as needed Pay: $24/hour Perks/Benefits: Medical, Vision and Dental Insurance Supplemental Insurance Flex Spending and HSA Accounts Pet Insurance Life Insurance 401 K plan with 3% employer match at one year of services PAID TIME OFF (PTO) accrual - PTO Donation Growth and Development Opportunities Employee Referral Program Scheduled pay increases Employee Assistance Program Mileage reimbursement T-Mobile, Verizon, Dell, and other National Brand Discounts TapCheck- access to 50% of your pay before payday. PAID training and orientation. Job Description What You Get To Do: The Quality Assurance Coordinator (QA) is responsible to ensure all programs are in compliance with state regulations and meet Dungarvin standards of quality. The Quality Assurance Coordinator (QA) must be aggressive in finding problems that are or could be a licensing issue. This position works collaboratively with the State Director, Area Directors, Area Managers and other program employees to identify problems, develops plans for correction, and assure that plans are fully implemented. The Quality Assurance Coordinator (QA), will closely monitor the completion of corrective actions to ensure timely completion by program management. Assess sites for quality assurance concerns as scheduled or upon request. Conduct ongoing monitoring of sites and follow-up with sites. Track, review and follow-up on abuse, neglect, and exploitation investigations. Analyze data from electronic and paper-based systems to inform the management team of quality issues related to service delivery. Provide in-the-moment training to staff when issues are observed. Provide support to the management team in responding to Requests for Proposals. Work closely with recruitment, training and retention leaders to inform the effectiveness of their efforts. Work with the management team to identify and train QA reviewers where needed. Work with the management team to develop, communicate, implement and provide feedback regarding prioritized QA goals. Provide leadership with policies, systems, and initiatives. Assist in quality assessment, intervention and enhancement of services and supports. Ensure the programs meet applicable licensure and certification requirements. Participate in Safety Committee. Represent the state on related national task forces dedicated to quality assurance. Work cooperatively with internal and external contacts to ensure services are provided in a timely manner, on a basis of quality according to organizational standards, contractual requirements and regulatory guidelines. Monitor and audit assigned employee timecards in accordance with payroll deadlines. Authorize overtime and mileage expenses for employees within assigned budgets. Approve timecards while assuring accuracy of pay and benefit category. Implementation of all organizational policies and procedures. Who We Are: At Dungarvin, we're all about making a positive impact in people's lives. We help individuals with different abilities, like intellectual disabilities, developmental disabilities, physical disabilities, autism, and mental health conditions, in a variety of programs with a focus on providing a person-centered approach. We're all about personal care and support, encouraging our clients to chase their dreams, while our team provides the help, they need to make important choices and get the care they deserve. Qualifications What Makes You A Great Fit: Bachelor's degree in a relevant field, such as healthcare, social work, or psychology Minimum of 3 years of experience working in the Human Services field Preferred- at least two years of experience in quality assurance Strong analytical skills, with the ability to build, review, and interpret complex data Excellent communication and interpersonal skills Knowledge of regulatory requirements related to IDD Supports, such as HIPAA, Licensing Requirements, and Person-Centered Service Provision Additional Information At Dungarvin, diversity and inclusion are a part of what makes our organization strong. Together, we can continue to work towards an inclusive culture that supports our employees and persons served. Dungarvin is an affirmative action and equal opportunity employer. All your information will be kept confidential according to EEO guidelines. 12/18

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. 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

Quality Assurance Assistant needed for a contract opportunity with Yoh Scientific's client located in Hammond, IN. This position is for a major utilities company, and the team is looking for someone with experience in GIS and ArcPro. Contract: 12-month contract with possibility of extension and/or conversion. Salary: $25 per hour, W2. Schedule: Monday - Friday, day shift. Responsibilities * Assist Quality Assurance (QA) personnel with GIS and administrative tasks of the Quality Assurance program for the Mapping & Records department. * Post simple GIS sessions, run GIS reports, assist with GIS resets, complete Quality Assurance work order packet reviews and close out, create IT Incident tickets, and support administrative Quality Assurance tasks. * Assist Quality Assurance (QA) staff with administrative tasks of the QA program for the Mapping & Records Department. * Update Access database with required data. * Process work order packets: receipt, assign, update logs, organize and maintain files in department, pull work order packets and send completed packets to archive. * Assist with creating IT incident tickets as needed. Qualifications * GIS Knowledge preferred but not required. Able to comprehend Engineering prints and As-built experience. * Anyone with experience in researching multiple databases to check accuracy of mapped data in GIS would be a good candidate. * Preferred Skills: GIS experience, ArcPro Experience, detail oriented, interpersonal/communication skills, organization skills, computer skills, able to work independently. * On-Site 5 days a week required. Opportunity is Calling, Apply Now! Recruiter: Ery Baniqued What's In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. * Medical, Dental & Vision Benefits * 401K Retirement Saving Plan * Life & Disability Insurance * Direct Deposit & weekly ePayroll * Employee Discount Programs * Referral Bonus Programs Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Estimated Min Rate: $25.00 Estimated Max Rate: $25.00 What's In It for You? We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include: * Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week) * Health Savings Account (HSA) (for employees working 20+ hours per week) * Life & Disability Insurance (for employees working 20+ hours per week) * MetLife Voluntary Benefits * Employee Assistance Program (EAP) * 401K Retirement Savings Plan * Direct Deposit & weekly epayroll * Referral Bonus Programs * Certification and training opportunities Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit ************************************************ to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: **********************************

Hubot - Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Quality Assurance Auditor for immediate addition to our fast growing team. Job Description: The Quality Assurance Auditor will perform quality control checks per specifications, identify non-conforming products and perform root cause analysis. Responsibilities: Review of production line parameters and performance for adherence to Company Standard Operating Procedures, Quality Guidelines and Facility Procedures Testing samples for physical adherence to Quality Specifications for Finished Product Pull and identify product samples for the internal lab, retain, and external customers Responsible for work area cleanliness and organization Instrument Calibration Verification Ability to follow detailed instructions Must be flexible to work 8-10 hour days Able to lift a minimum of 30 lbs Ability to climb stairs/ladder Ability to work in a Cleanroom environment and lab Must have good communication skills, both verbal and written Able to work safely, carefully and follow strict guidelines Detail oriented Other duties as assigned Education and/or Experience: Education: High School or higher, excellent mathematics and problems solving skills preferred 2-3 + years hands-on experience with quality systems and checks Microsoft (Word/Excel) skills Math skills Benefits Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Thank you for your interest and consideration of a career with Hubot - Tri Pac, Inc. Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application. Powered by JazzHR fq Wd7Qurq6

Embrace the opportunity to positively change someone's life! Join our Indiana team as a Quality Assurance Coordinator! Dungarvin is hiring a QA Coordinator. In this role you will be responsible for ensuring high-quality services. This includes program oversight, conducting site visits, independent Electronic Health Record (EHR) data reviews, and follow through with Operations. Why This Role: Personal fulfillment, meaningful career, and the chance to make a difference. Build meaningful bonds with persons served and their families. Further develop your leadership experience in the social service field Varied day-to-day experiences; no two days are the same. Schedule: Full-time with potential travel throughout the state as needed Pay: $24/hour Perks/Benefits: Medical, Vision and Dental Insurance Supplemental Insurance Flex Spending and HSA Accounts Pet Insurance Life Insurance 401 K plan with 3% employer match at one year of services PAID TIME OFF (PTO) accrual - PTO Donation Growth and Development Opportunities Employee Referral Program Scheduled pay increases Employee Assistance Program Mileage reimbursement T-Mobile, Verizon, Dell, and other National Brand Discounts TapCheck- access to 50% of your pay before payday. PAID training and orientation. Job Description What You Get To Do: The Quality Assurance Coordinator (QA) is responsible to ensure all programs are in compliance with state regulations and meet Dungarvin standards of quality. The Quality Assurance Coordinator (QA) must be aggressive in finding problems that are or could be a licensing issue. This position works collaboratively with the State Director, Area Directors, Area Managers and other program employees to identify problems, develops plans for correction, and assure that plans are fully implemented. The Quality Assurance Coordinator (QA), will closely monitor the completion of corrective actions to ensure timely completion by program management. Assess sites for quality assurance concerns as scheduled or upon request. Conduct ongoing monitoring of sites and follow-up with sites. Track, review and follow-up on abuse, neglect, and exploitation investigations. Analyze data from electronic and paper-based systems to inform the management team of quality issues related to service delivery. Provide in-the-moment training to staff when issues are observed. Provide support to the management team in responding to Requests for Proposals. Work closely with recruitment, training and retention leaders to inform the effectiveness of their efforts. Work with the management team to identify and train QA reviewers where needed. Work with the management team to develop, communicate, implement and provide feedback regarding prioritized QA goals. Provide leadership with policies, systems, and initiatives. Assist in quality assessment, intervention and enhancement of services and supports. Ensure the programs meet applicable licensure and certification requirements. Participate in Safety Committee. Represent the state on related national task forces dedicated to quality assurance. Work cooperatively with internal and external contacts to ensure services are provided in a timely manner, on a basis of quality according to organizational standards, contractual requirements and regulatory guidelines. Monitor and audit assigned employee timecards in accordance with payroll deadlines. Authorize overtime and mileage expenses for employees within assigned budgets. Approve timecards while assuring accuracy of pay and benefit category. Implementation of all organizational policies and procedures. Who We Are: At Dungarvin, we're all about making a positive impact in people's lives. We help individuals with different abilities, like intellectual disabilities, developmental disabilities, physical disabilities, autism, and mental health conditions, in a variety of programs with a focus on providing a person-centered approach. We're all about personal care and support, encouraging our clients to chase their dreams, while our team provides the help, they need to make important choices and get the care they deserve. Qualifications What Makes You A Great Fit: Bachelor's degree in a relevant field, such as healthcare, social work, or psychology Minimum of 3 years of experience working in the Human Services field Preferred- at least two years of experience in quality assurance Strong analytical skills, with the ability to build, review, and interpret complex data Excellent communication and interpersonal skills Knowledge of regulatory requirements related to IDD Supports, such as HIPAA, Licensing Requirements, and Person-Centered Service Provision Additional Information At Dungarvin, diversity and inclusion are a part of what makes our organization strong. Together, we can continue to work towards an inclusive culture that supports our employees and persons served. Dungarvin is an affirmative action and equal opportunity employer. All your information will be kept confidential according to EEO guidelines. 12/18

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.

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