Quality assurance specialist jobs in Greenwood, IN - 252 jobs

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. To read and review this privacy notice click here

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

Title: Global Quality Assurance Manager Worksite Location: Westfield, Indiana Duties: Indiana Mills & Manufacturing Inc. d/b/a IMMI seeks a Global Quality Assurance Manager to coordinate and manage all incoming inspection and testing activities. Assist the appropriate Design Engineering, Product Engineering and Manufacturing Engineering personnel to conduct, develop and document Process and Design FMEA's, utilizing the APQP process. Assist the Supplier Quality Manager and Purchasing teams in supplier development activities and/or testing to validate components. Provide and maintain a state-of-the-art inspection lab to serve IMMI Purchasing, Engineering and manufacturing in the inspection and testing of incoming and outgoing material. Develop and improve the overall inspection and testing process for better effectiveness. Supervise and direct the activities of the Quality Assurance Technician team. Administer the IMMI Quality System within the Quality Assurance Lab to ensure compliance with ISO-9001 or appropriate standards and all customer expectations. Assist with IMMI QMS internal and external auditing activities. Ensure proper housekeeping in the Quality Assurance Lab. Assist in the development of new test fixtures, methods and equipment required by acting as liaison with internal and external engineering teams. Assist in writing summary reports that are worded appropriately, preventing the casting of doubt on IMMI products, development and testing efforts. Provide technical support to Reliability and Compliance, Engineering and Marketing by representing the Quality Assurance group as needed. Assist with customer visits as requested. Support and/or maintain a comprehensive corrective action program using problem solving tools and root cause analysis to identify and address product, process, or testing integrity or reliability issues. Ensure the confidentiality of sensitive information with internal or external customers. Insure and maintain data integrity of all testing results. All other duties as assigned by the Vice President of Quality Assurance. Up to 10% to customers, suppliers, and/or other IMMI plants when needed. The geographic areas for such travel include: IMMI plants located in Georgia, North Carolina, Illinois, and Kansas, and IMMI's customers and suppliers located in Oklahoma, Texas, Wisconsin, Washington, and Ohio. Requirements: Bachelor's Degree in industrial engineering, mechanical engineering, electromechanical engineering, or related field. 2 years of experience with the test and validation of new product designs and conformance of production testing for seat belts, air bags, seats, steering wheels as it relates to FMVSS, ECE, or customer specific testing including development and maintenance of appropriate fixtures to hold part in test position appropriately and review and approval of test reports. 2 years of experience in managing production floor quality as it pertains to safety and quality fit, form, and function including fast response for quality issues. 2 years of experience in the corrective action process for internal or external (customer) concerns when raised by using the appropriate investigative tools and report to the appropriate representative (internal manger/VP or customer). 2 years of experience in Quality Management System and overseeing compliance to international standards, including but not limited to IATF, BAM, ISO, and VCA. 2 years of experience in the cross functional collaboration with Engineering and Quality in the Design Review process for development of new products. This includes application of past problem history and/or testing for part performance. 2 years of experience in execution of APQP (Advance Quality Planning) for the launch of new products and change point of existing product. 2 years of experience in the warranty and field return investigations including trend analysis, field return tracking, and corrective action report for such claims. 2 years of experience in the warranty and field activities for product performance. Knowledge in FMVSS, ECE, and development testing of Seat Belts, Air Bags, Steering Wheels, and other safety products. To apply: Interested candidates should visit *************************************** UI/CandidateExperience/en/sites/CX_1/ and search by keyword “Global Quality Assurance Manager” and Location (Westfield, Indiana, United States). LR11655.0***********-8579-7244v2

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 in STEM related field, Engineering degree preferred. Additional Skills/Preferences: Previous experience in 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 Strong oral and written communication and interpersonal skills Demonstrated decision making and problem-solving skills Technical writing skills 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. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $148,500 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Job DescriptionJob Title: QA/QC Manager Department: Quality Control The QA/QC Manager both reports to and takes direction from the Senior Director of Operations. The primary responsibility of the QA/QC Manager is to ensure through testing, so all products and services meet client requirements and company standards. The individual must possess a strong background in the Corporate and Company arena. Graywolf Integrated Construction company is a diverse industrial contractor with significant emphasis on ASME Boilers, Pressure Vessels, and Pressure Piping installations and repairs. Candidate must possess a strong background in the ASME B&PV Codes, including but not limited to Sections I, VIII-1, IX B31.1 and B31.3. Candidate must possess a strong background in the development, implementation, and understanding of ASME Welding Procedures (WPS) and Welder Performance Qualifications (WPQ). Candidate must possess a strong background in the NATIONAL BOARD OF Boiler and Pressure Vessel Inspectors (NBBPVI) NBIC Codes for Repairs and Alterations. Performance Objectives: Mentors and coaches' staff; interprets performance and provides feedback. Leads and coordinates the daily activities of the project team. Interprets and applies a strong understand of key indicators to make effective business decisions. Embraces new opportunities and tough challenges with a sense of urgency, and enthusiasm. Secures and deploys resources effectively and efficiently. Cultivates innovation and creates new and better ways for the organization to be successful. Provides direction, delegates, and removes obstacles to get work done with focus on continuous improvement. Develops people to meet both their career goals and organizational goals. Creates a climate where people are motivated to do their best to help the organization achieve it objectives. Gains the trust and confidence of others through honesty, integrity, and authenticity. Rebounds from setbacks and adversity when dealing with difficult situation. Technical Objectives: Manages and oversees corporate and project quality to ensure compliance with Codes, standards & quality program requirements. Promotes Quality Achievement and performance improvement throughout the organization. Manages the development and implementation of the QMS for construction, execution, inspection of documentation, and operations activities including: Planning duties within the QA/QC group to execute QA/QC activities. Establishing standards of service for customers, clients, and departments Identifying & developing workforce planning schedules & quality related training needs Provides functional leadership, mentorship, and direction to all project quality personnel. Develops and implements risk-based inspection activities and processes. Oversees supervision of all visual and NDE inspections including subcontractors. Creates inspection and test plans for new construction, repair work, and alterations. Identifies and plans how to rectify inspection gas issues. Ensures that total quality management principles are integrated in all functions of organization. Promotes, trains, encourages, and otherwise ensures adherence to the QMS as well as applicable Codes and Standards. Ensures all QA/QC requirements are met and are fully in compliance. This includes inspection and testing of “in progress” as well as completed systems and installations. Develops testing plans and manages both defect management and change management processes. Ensures Quality Engineers or others assist with redesign and/or modifications. Plans and manages the activities of departmental staff and provides technical guidance and co-Co-ordination to site personnel. Oversee the continuity and maintenance of the Company's Local, State, or Jurisdictional Certification and Licenses, as well as keeping the Company's ASME and NATIONAL BOARD Certifications and stamps current. Safety Objectives: Managers are responsible for integrating the company's Health and Safety procedures and controls into every activity they manage. All managers are directly accountable for the provisions and maintenance of an effective Safety Program. * Refer to Graywolf Safety Manual for a description of responsibilities. Experience (Required): Above average ability to communicate effectively with all levels of the organization including craft, project management, corporate management, client representatives, and outside regulatory authorities. Must excel at co-ordination, organization, written and verbal communication skills, with strict emphasis on accuracy and attention to detail. Experience working within local jurisdictional authorities and regulatory bodies. Solid understanding of requirements associated with project specific documentation related to turnover, inspection, testing, installations, and quality control including understanding of safety related implementations associated with each process. Supervision of safe storage and verification of all projects related documentation. Experience in project management, including project execution. Education (Required): Certification in architectural, structural, construction or engineering technology or related field with a minimum of 15 + years of experience in heavy construction. American Welding Society (AWS) CWI Certificate Knowledge of Occupational Safety and Health Administration (OSHA) A bachelor's degree in occupational safety is preferred but will consider years of experience in similar role. Graywolf Integrated Construction Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law. #LI-AC1

Working closely with the QA Operations Supervisor and IQC Manager. QA Specialist will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Specialist, IQC will need to provide support with identifying operational and quality gaps. The Quality Assurance Specialist, IQC will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Specialist, IQC will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Specialist, IQC will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: · Maintain a Quality Assurance presence and provide verification of incoming pharmaceutical shipments and contents against purchase orders, materials specifications and receiving in line with INCOG SOP's. Review and approve documentation, including but not limited to logbooks, material packets, material specifications, packing lists, work orders, procedures, etc. · Collaborate with Supply Chain, IQC, and Operations team and lead or provide support with investigations to resolve inventory and material, consumables, and component related deviations. · Support other QA personnel from Operations as necessary with batch record reviews, corrections, floor operations, etc. · Inspect products for damage, discrepancies, or expired items and report any issues to the Warehouse Manager. · Prioritize and coordinate his/her time in balancing timelines with product quality assurances. · Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. · Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. · Provide Quality Assurance oversight into the picking of product Bill of Materials (BOM). · Assist Supply Chain Management with Critical Alarm reporting with freezer farm or incubator alarms. · Perform both provisional and full release of materials. · Dispose of Filled Inspected Product (FIP) rejects following batch disposition. · Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. · Assist Operations with incoming and outgoing Material Transfer counts. · Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. · Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. · Provide Quality Assurance oversight with Supply Chain inventory cycle counts and investigate any discrepancy. · Ability to manage multiple projects in a fast-paced environment. · Assist in maintaining records for regulatory inspections and audits. Special Job Requirements: · This position will support primarily first shift (7:00 am - 3:30 pm) with occasional weekend support, dependent on operations' needs. · Bachelor's Degree required or equivalent; degree preferred to be in Logistics, Supply Chain, Management, Biology or Chemistry · Minimum of 4 years with experience working as Quality in a GMP Manufacturing environment, Raw Material/ Component/Consumable release and/or as an Operator within a Pharmaceutical Supply Chain/Warehouse environment. · Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. · Understanding of Good Documentation Practices (GDPs) and its criticality. · Ability to obtain Powered Industrial Lift Certification. · Excellent written and verbal communication skills. · Ability to lift 50 lbs. · General computer skills evidenced by hands-on work with inventory management systems; and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: · Hands-on experience with aseptic manufacturing, inspecting finished products, and supply chain or warehousing. · Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

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

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

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise 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

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

Description & Requirements In today's dynamic regulatory environment, public companies must uphold the highest standards of financial integrity and IT risk management. As an SEC Auditor, you will play a critical role in ensuring compliance with SEC regulations by performing financial statement and IT audits. You will help clients identify and manage business and technology risks, strengthen internal controls, and support the integrity of financial reporting What You Will Do: * Execute integrated audits of financial statements and IT systems for SEC registrants, ensuring compliance with PCAOB and SEC standards. * Perform audit testing on financial statement accounts such as cash, accounts payable, and fixed assets. * Assess and test internal controls over financial reporting (ICFR), including IT general controls (ITGCs) and application controls, in accordance with SOX 404 requirements. * Conduct walkthroughs and substantive testing of financial statement accounts, disclosures, and related IT processes. * Evaluate the design and operating effectiveness of IT controls for applications, databases, operating systems, networks, and reporting tools. * Collaborate with client teams to understand business processes, IT environments, and control frameworks; obtain audit evidence; and analyze testing results. * Draft audit findings, management letter comments, and recommendations for remediation. * Participate in discussions with clients and leadership regarding audit results and emerging risks. * Stay informed on SEC, PCAOB, and IT risk trends impacting clients. * Deliver an exceptional client experience through timely and responsive communication. Minimum Qualifications: * Bachelor's degree in a related field, preferably in Management Information Systems or Computer Science. * Eligibility to sit for the CPA exam, meeting educational requirements as defined by the applicable state board of accountancy. * Proficiency in Microsoft Office Suite. * Ability to travel for client engagements and internal meetings, including overnight stays. Preferred Qualifications: * Masters degree in a related field, preferably in Management Information Systems or Computer Science. * Prior experience or internships in public accounting with exposure to SEC or IT audits. * Eligibility to sit for the CISA exam or CISA certification. #LI-IND #LI-JB1

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.

Job Title: QA/QC Manager Department: Quality Control The QA/QC Manager both reports to and takes direction from the Senior Director of Operations. The primary responsibility of the QA/QC Manager is to ensure through testing, so all products and services meet client requirements and company standards. The individual must possess a strong background in the Corporate and Company arena. Graywolf Integrated Construction company is a diverse industrial contractor with significant emphasis on ASME Boilers, Pressure Vessels, and Pressure Piping installations and repairs. Candidate must possess a strong background in the ASME B&PV Codes, including but not limited to Sections I, VIII-1, IX B31.1 and B31.3. Candidate must possess a strong background in the development, implementation, and understanding of ASME Welding Procedures (WPS) and Welder Performance Qualifications (WPQ). Candidate must possess a strong background in the NATIONAL BOARD OF Boiler and Pressure Vessel Inspectors (NBBPVI) NBIC Codes for Repairs and Alterations. Performance Objectives: Mentors and coaches' staff; interprets performance and provides feedback. Leads and coordinates the daily activities of the project team. Interprets and applies a strong understand of key indicators to make effective business decisions. Embraces new opportunities and tough challenges with a sense of urgency, and enthusiasm. Secures and deploys resources effectively and efficiently. Cultivates innovation and creates new and better ways for the organization to be successful. Provides direction, delegates, and removes obstacles to get work done with focus on continuous improvement. Develops people to meet both their career goals and organizational goals. Creates a climate where people are motivated to do their best to help the organization achieve it objectives. Gains the trust and confidence of others through honesty, integrity, and authenticity. Rebounds from setbacks and adversity when dealing with difficult situation. Technical Objectives: Manages and oversees corporate and project quality to ensure compliance with Codes, standards & quality program requirements. Promotes Quality Achievement and performance improvement throughout the organization. Manages the development and implementation of the QMS for construction, execution, inspection of documentation, and operations activities including: Planning duties within the QA/QC group to execute QA/QC activities. Establishing standards of service for customers, clients, and departments Identifying & developing workforce planning schedules & quality related training needs Provides functional leadership, mentorship, and direction to all project quality personnel. Develops and implements risk-based inspection activities and processes. Oversees supervision of all visual and NDE inspections including subcontractors. Creates inspection and test plans for new construction, repair work, and alterations. Identifies and plans how to rectify inspection gas issues. Ensures that total quality management principles are integrated in all functions of organization. Promotes, trains, encourages, and otherwise ensures adherence to the QMS as well as applicable Codes and Standards. Ensures all QA/QC requirements are met and are fully in compliance. This includes inspection and testing of “in progress” as well as completed systems and installations. Develops testing plans and manages both defect management and change management processes. Ensures Quality Engineers or others assist with redesign and/or modifications. Plans and manages the activities of departmental staff and provides technical guidance and co-Co-ordination to site personnel. Oversee the continuity and maintenance of the Company's Local, State, or Jurisdictional Certification and Licenses, as well as keeping the Company's ASME and NATIONAL BOARD Certifications and stamps current. Safety Objectives: Managers are responsible for integrating the company's Health and Safety procedures and controls into every activity they manage. All managers are directly accountable for the provisions and maintenance of an effective Safety Program. * Refer to Graywolf Safety Manual for a description of responsibilities. Experience (Required): Above average ability to communicate effectively with all levels of the organization including craft, project management, corporate management, client representatives, and outside regulatory authorities. Must excel at co-ordination, organization, written and verbal communication skills, with strict emphasis on accuracy and attention to detail. Experience working within local jurisdictional authorities and regulatory bodies. Solid understanding of requirements associated with project specific documentation related to turnover, inspection, testing, installations, and quality control including understanding of safety related implementations associated with each process. Supervision of safe storage and verification of all projects related documentation. Experience in project management, including project execution. Education (Required): Certification in architectural, structural, construction or engineering technology or related field with a minimum of 15 + years of experience in heavy construction. American Welding Society (AWS) CWI Certificate Knowledge of Occupational Safety and Health Administration (OSHA) A bachelor's degree in occupational safety is preferred but will consider years of experience in similar role. Graywolf Integrated Construction Company is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law. #LI-AC1

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)

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 Overview Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers. The QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's. The Principal Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements. Key Objectives/Deliverables: Lead/ provide support to launch new products/ packages/ CMs Participate on Joint Process Teams Understand Lily global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations. Levelling, reviewing, and approving of event investigations and changes. Work with Lilly support groups and SME's to resolve product related issues Participate in the creation and revision of standard operating procedures Participate on Six Sigma Projects to help improve productivity Provide support on site or remotely during inspections Author and track compliance to the CM Quality Agreements and CM Quality Plans Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Use regular visits, JPTs and other communications to help to assess/monitor performance. Routinely have face-to-face communications with CMs Track and monitor Quality metrics for trends at the CM Support Qualifications/ Validation document creation and reviews Provide and coordinate designated sections for Annual Reports and Annual Product Reviews Execute SOP assessments of CMs and track completion of outstanding issues Support CMs effort to maintain and improve their quality systems Provide technical leadership and project management oversight to drive improvements to CM quality systems Build and maintain regular communication with External Manufacturers and awareness of issues/progress including reporting back to DPEM Management. Also responds to request of information and data. Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight Network with external partners and resources to share and learn best practices and trends within the industry Support batch release activities by determining final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations. Basic Qualifications: Bachelor´s Degree in Pharmacy, Chemistry, Biological Science or other relevant field 5+ year of parenteral product manufacturing and quality experience Additional Skills/ Preferences: Knowledge of Pharmaceutical Manufacturing Operations Strong written and communication skills, especially attention to detail in written procedures and protocol development. High learning agility. Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment. Ability to organize, prioritize, multi-task and influence others. Strong decision making and problem-solving skills. Willingness to learn new technologies. Capability to work in a virtual and complex environment. Proven ability to work independently or as part of a Team to problem solve Regulatory related experience. Established technical, quality, and internal networks. Experience with Lilly systems (SAP, Trackwise, Q docs…etc.). Preferable minimum of 5 years of experience supporting manufacturing Additional Information: Shift is days, but off-hours may be necessary to support operations Travel up to 30% 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. This is a 2nd shift position. Essential Job Functions: * Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. * Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. * Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. * Support other QA personnel with batch record reviews, material release, etc. * Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. * Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. * Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. * Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. * Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. * Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. * Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: * This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations' needs. * Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) * Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. * Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. * Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. * General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: * Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs). * Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

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

Job Title: QA/QC Manager Department: Quality Control

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