Quality assurance specialist jobs in Racine, WI

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. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. 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). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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. 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 $133,500 - $246,400 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

STV is currently looking for a QA/QC Construction Manager to join our Construction Management team. STV is seeking a QA Manager will be part of the team responsible for the development of Power Harvesting Projects. The QA Manager will manage overall project objectives including design and construction within approved budgets. Responsible for overseeing and coordinating the day-to-day activities in the field, managing and coordinating the flow of information, controlling costs, managing and controlling the schedule, monitoring the safety programs, as well as verifying that the completed work is constructed to a quality level consistent with the requirements of the construction documents. Roles and responsibilities include: Demonstrate commitment to an Injury-Free Environment through own actions and mentoring others, ensuring Safety program is followed Provide QA construction and design management, and project leadership Provide QA project single point of contact for project development and delivery Facilitate decision-making to drive solutions, schedules, and manage change as required Attend and participate in project meetings for design and construction including the OAC, discipline work groups, progress, pre-construction and pre-award Apply influence, strategies, and negotiation skills to identify options and recommend solutions Oversee and report project progress on scope, schedule, budget and contractor performance weekly or as required Review trade contracts and bid packages, as well as coordinate the receiving process Maintain relationships with internal partners, designers, consultants and GC team Set-up QA/QC procedures, review inspection and test data for compliance with specifications and standards and conduct quality field inspections Review and maintain site logistics plan, in coordination with GC, Operations team and Consultant team Qualifications include: Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Civil Engineering, Architecture, Construction Project Management, or Construction Management or equivalent experience Possess excellent communication, organization, and leadership skills Proficiency in commercial and industrial architecture and engineering with a primary focus on datacenter design and construction Able to work with other technical and non-technical groups in a fast-paced environment and do so with an even temperament. Experience required: Minimum of 10 years of relevant experience in construction management Compensation Range: $101,562.83 - $135,417.11 Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At STV, we are fully committed to expanding our culture of diversity and inclusion, one that will reflect the clients we serve and the communities we work in, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description we encourage you to apply anyways. You may be just the right candidate for this or other roles. STV offers the following benefits • Health insurance, including an option with a Health Savings Account • Dental insurance • Vision insurance • Flexible Spending Accounts (Healthcare, Dependent Care and Transit and Parking where applicable) • Disability insurance • Life Insurance and Accidental Death & Dismemberment • 401(k) Plan • Retirement Counseling • Employee Assistance Program • Paid Time Off (16 days) • Paid Holidays (8 days) • Back-Up Dependent Care (up to 10 days per year) • Parental Leave (up to 80 hours) • Continuing Education Program • Professional Licensure and Society Memberships STV is committed to paying all of its employees in a fair, equitable, and transparent manner. The listed pay range is STV's good-faith salary estimate for this position. Please note that the final salary offered for this position may be outside of this published range based on many factors, including but not limited to geography, education, experience, and/or certifications.

At Johnson Controls, we are reimagining how we work-building a future powered by product-driven innovation, Agile delivery, and sustainable solutions. Alongside the advances of AI and a renewed culture of problem solving, we're transforming how our teams deliver customer value. This role is at the heart of that transformation - shaping how the enterprise adopts a product-centric operating model and ensuring measurable outcomes for our people, customers, and communities. You are a strategic visionary who thrives at the intersection of business strategy, product thinking, and organizational change. You bring deep expertise in scaling product models and Agile practices, and you know how to build momentum for transformation. You empower cross-functional teams to deliver meaningful outcomes and foster a culture of continuous improvement and customer obsession. What You Will Do As the Head of the Product Model Center of Excellence (PMCoE) for our IT organization, led by the CDIO, you will lead the enterprise-wide shift from project-based delivery to a product-centric operating model. You will define the vision, strategy, and execution roadmap to scale product management capabilities, drive customer-centric innovation, and embed product thinking across the organization. You will lead a dedicated Center of Excellence team focused on three key pillars: Scaling the Product Operating Model Champion a Product-Centric Vision: Define and evangelize a compelling product transformation strategy aligned with enterprise goals and customer outcomes. Drive Strategic Roadmaps: Co-create and iterate on transformation roadmaps with prioritized initiatives, clear outcomes, and measurable impact. Enable Product Governance: Design and evolve a scalable product taxonomy and governance model that promotes clarity, ownership, and alignment. Align Cross-Functional Stakeholders: Partner with Business, Finance, Technology and other leaders to ensure alignment, secure buy-in, and sustain momentum. Measure and Communicate Impact: Define success metrics, track value delivery, and transparently communicate progress and learnings. Capability Building & Coaching Build Product Management Excellence: Develop and scale training programs, coaching structures, and communities of practice for product owners, product managers and cross-functional teams. Embed Agile Product Thinking: Promote iterative delivery, customer feedback loops, and outcome-driven planning across product teams. Partner for Leadership Enablement: Collaborate with senior leaders to embed product mindsets and empower them to lead in a product-centric environment. Tooling, Data & Insights Shape the Product Enablement Ecosystem: Lead the selection, integration, and continuous improvement of tools that empower product teams throughout the lifecycle - from strategy and discovery to delivery and outcome measurement. Enable Data-Driven Decision Making: Use insights to assess product performance, customer impact, and transformation progress. Standardize Practices for Scale: Co-create adaptive standards and feedback loops that foster learning, consistency, and enterprise-wide alignment. How You Will Lead Empower High-Performing Teams: Build and lead a growth-minded team that works across all of IT to deliver value, embrace feedback, and continuously improve. Influence Across the Enterprise: Develop strong partnerships with executives and stakeholders to foster commitment and accelerate adoption. Model Product Leadership: Demonstrate strategic stewardship of product practices, tools, and governance. Lead with Curiosity and Intentionality: Approach transformation with a learning mindset - seeking input, testing assumptions, and iterating toward scalable, value-driven solutions. What We Look For We're seeking a visionary leader and proven change agent with deep expertise in product model transformation and Agile delivery. You are passionate about driving customer-centric innovation and capable of influencing at all levels of the organization. Requirements: 5+ years of leadership experience in product management, Agile transformation, or enterprise strategy roles Proven success leading large-scale product model transformations in complex, matrixed organizations Experience building product management capabilities, training programs, and Centers of Excellence Deep understanding of Agile frameworks, product management, and customer feedback loops Excellent relationship-building, influencing, communication, and organizational skills Inspirational leader who motivates and empowers teams Systems thinker with an enterprise agility mindset Change management acumen to guide the organization through transformation Experience with design thinking, human centered design, hypothesis testing, value stream mapping, customer journey mapping, product discovery, experimentation, etc. High emotional intelligence and empathy to build trust and influence without authority Committed to continuous improvement and capability development Skilled facilitator of change who takes a collaborative and inclusive approach Analytical mindset with experience in productivity and maturity assessments Preferred: Experience with business case development, product funding models, and financial planning Industry experience in Industrials, Manufacturing, or related sectors HIRING SALARY RANGE: $141,000 - 188,000 (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, location and alignment with market data.) This role offers a competitive Bonus plan that will take into account individual, group, and corporate performance. This position includes a competitive benefits package. For details, please visit the About Us tab on the Johnson Controls Careers site at ***************************************** Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.

As a QA Remediation Specialist, you will play a critical role in ensuring compliance with FDA regulations and requirements. Your responsibilities will include reviewing and analyzing FDA 483 observations and associated documentation. You will collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs), assist in root cause investigations, and ensure documentation meets regulatory expectations. Additionally, you will draft, revise, and manage SOPs, work instructions, and quality records to align with compliance requirements. Your role will also involve supporting training efforts related to new or revised procedures, monitoring the progress of remediation activities, and tracking CAPA effectiveness. You will prepare and present status updates and reports to management and stakeholders, ensuring all remediation activities are completed within defined timelines and meet FDA expectations. Responsibilities * Review and analyze FDA 483 observations and associated documentation. * Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs). * Assist in root cause investigations and ensure documentation meets regulatory expectations. * Draft, revise, and manage SOPs, work instructions, and quality records to align with compliance requirements. * Support training efforts related to new or revised procedures. * Monitor progress of remediation activities and track CAPA effectiveness. * Prepare and present status updates and reports to management and stakeholders. * Ensure all remediation activities are completed within the defined timeline and meet FDA expectations. Essential Skills * Quality assurance * FDA compliance * Remediation * Experienced in communicating with FDA inspectors to respond to regulatory inquiries * Experience with FDA 483 observations and contribution to remediation efforts * Demonstrated experience creating and maintaining quality documentation Additional Skills & Qualifications * Bachelor's degree in Life Sciences, Engineering, or related field * Minimum 3-5 years of experience in pharmaceutical quality assurance or compliance * Proven experience with FDA 483 remediation and GMP regulations * Strong understanding of CAPA systems, deviation management, and documentation practices * Excellent communication, organizational, and analytical skills * Ability to work independently and in a fast-paced, deadline-driven environment * Experience with FDA audits and inspection readiness * Familiarity with electronic quality management systems (eQMS) Work Environment This position requires you to work onsite full-time. You should be comfortable working with a remote manager and providing weekly updates. You will need to track work completed on a weekly basis and monitor deliverables, while organizing your schedule and working independently. Job Type & Location This is a Contract position based out of Lake Villa, IL. Pay and Benefits The pay range for this position is $55.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Lake Villa,IL. Application Deadline This position is anticipated to close on Dec 13, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

The QA Specialist is responsible for monitoring products and employee practices on the manufacturing floor to insure the safety and quality of products manufactured by Georgia Nut Company. PRIMARY RESPONSIBILITIES 1. Responsible to report any food safety and quality problems to personnel with authority to initiate action. 2. Perform QA in-process inspections for each department/line once per shift by checking the following: production paperwork, retain sample, code date/lot number/best by date, weight check documentation, metal detection documentation, label, color code, department cleanliness employee GMP practice and checking for any potential allergen cross-contamination 3. Perform scale checks once per day 4. Holds: * Place on hold materials due to quality, food safety per Hold Policy * Send out electronic hold reports to through SharePoint and transfer PQ product to 100# * Release products which are on hold when approval is received * Generate disposal reports for materials on hold to be disposed 5. Perform metal detector check as an audit during production 6. DVU: * Perform verifications on DVU - (2 Log and 5 Log) * Perform alarm checks for roasters 7. Perform changeover validation on production lines and perform clean equipment/ATP swabbing on equipment after sanitation policy 6615 8. Perform environmental swabbing during manufacturing policy 6614 9. Perform yearly allergen validation policy 6605 10. Maintain inventory of QA supplies 11. Make retain samples for Production 12. Conduct internal plant audits 13. Conduct glass and brittle plastic audit 14. Perform magnet pull test annually 15. Perform metal detection test on metal detectable ear plugs and band aids twice a year 16. Monitor GMP on the floor and send out daily report of issues noted 17. Train new QA Techs and QA Specialists 18. Generate maintenance work requests 19. Shut down lines/department when a serious food safety issue is noticed 20. Filing QA documents 21. Conduct any other functions as required by the QA department 22. Check oil FFA and water chlorine 23. Back-up for QA Specialist - I Qualifications KNOWLEDGE AND SKILL REQUIREMENTS * Minimum high school diploma - college a plus * Minimum 1 year of previous QA/QC or operational experience in food manufacturing * Basic math * Good organization and time management skills * Attention to detail * Good communication skills (written and oral) TRAINING REQUIREMENTS * GMP Training * Allergen Training * All GNC Safety Training Required * HACCP Training * All Food Safety Training * All GNC QA policies * All GNC HR Policies

Salary: $115,000-$135,000 Benefits: Medical, Dental, Vision, Life, 401k, Holidays, Vacation Job Type: Full-Time Typical Hours: M-F; 8 AM - 6 PM Quality Assurance Manager (pharmaceutical and/or biotechnology quality exp. req.) Description Our client, a growing pharmaceutical manufacturing company, is seeking a Quality Assurance Manager to join their team in the Greater Milwaukee Area. Reporting to the Director of Quality, this hands-on role is responsible for ensuring that quality standards, regulatory requirements, and customer expectations are consistently met through strong systems, precise documentation, and proactive compliance oversight. The company's US site is backed by a global parent company that's investing heavily in its American operations, so there's a lot of excitement and growth ahead. You'd be joining a close-knit team of 40 in Wisconsin, which means your days will have plenty of variety. They're seeking someone who can adapt as processes and systems evolve, and who can translate complex, technical information into clear, understandable insights for the entire team. If you have a well-rounded background in QA with experience overseeing GMP requirements, and bring an approachable, patient demeanor, this role could be an excellent fit. Your contributions will be visible and valued across an organization with a strong international footprint. Quality Assurance Manager (pharmaceutical and/or biotechnology quality exp. req.) Responsibilities • Establish, uphold, and enhance quality and compliance standards • Monitor internal systems to ensure alignment with regulatory and customer requirements • Oversee supplier and partner quality programs, including audits, qualifications, etc. • Manage compliance processes such as deviations, investigations, and product release activities • Support regulatory submissions and interactions with external agencies and certification bodies • Lead audit programs, ensuring timely reporting, follow-up, and corrective actions • Author, evaluate, and approve, equipment IQ/OQ protocols • Supervise QA documentation, including SOPs, batch record reviews, and material approvals • Promote adherence to cGMP or nutraceutical quality systems • Respond to customer quality concerns, complaint investigations, and product inquiries • Collaborate across departments to maintain a culture of continuous improvement Quality Assurance Manager (pharmaceutical and/or biotechnology quality exp. req.) Qualifications • Bachelor's degree in life sciences required • Current experience within pharmaceutical or biotech required • Minimum 5 years of quality assurance experience in a GMP-regulated environment required • Supplier management experience required

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace. With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including. • Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here) • Collabera listed in GS 100 - recognized for excellence and maturity • Collabera named among the Top 500 Diversity Owned Businesses • Collabera listed in GS 100 & ranked among top 10 service providers • Collabera was ranked: • 32 in the Top 100 Large Businesses in the U.S • 18 in Top 500 Diversity Owned Businesses in the U.S • 3 in the Top 100 Diversity Owned Businesses in New Jersey • 3 in the Top 100 Privately-held Businesses in New Jersey • 66th on FinTech 100 • 35th among top private companies in New Jersey *********************************************** Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Job Description The Quality Assurance Project Specialist is responsible for producing the highest quality results while operating within the constraints of the business timelines and guidelines. Responsibilities also include developing positive relations with other individuals within as well as outside the department. In addition to the duties described, the incumbent completes all other projects as assigned by management as well as assures compliance to Nutritional Regulations and Good Manufacturing Practices. Five - seven years of customer support, business, or project planning experience preferred. A high degree of interpersonal relations skills. Excellent verbal and written communication skills. Able to work independently and/or function with minimal supervision. Must be able to work under pressure and stress common to office environments. Must be able to maintain a high degree of accuracy and analytical thinking. Must be able to deal effectively with problems and customers. Must have knowledge of applicable regulatory standards and requirements for infant formula and nutritional products. Must have Advanced knowledge of MS Office Suite, Adobe Acrobat, Visio, Access, and Lotus. Qualifications o Review executed Batch Record packets and associated documentation. o Line clearance/AQL o Perform biyearly review of files samples o Release of raw materials o Write CR's and route for approval. B.S. degree in science, business or technical related field to perform all aspects of the job. Additional Information All your information will be kept confidential according to EEO guidelines.

Skill (QA) efforts for IT Project Services Total Experience 8 yrs. Max Salary $ DOE Per Hour Employment Type Contract Jobs (Temp/Consulting) Job Duration 12+ Months Domain Any Description • Drive quality assurance (QA) efforts for IT Project Services team. • Collaborate with IT leadership to define and execute QA roadmaps and strategies. • Develop, implement and improve innovative QA capabilities, strategies, approaches and services. • Build and maintain a stable and reliable automation infrastructure. • Oversee test automation usage to optimize project quality and delivery. • Develop, implement and maintain QA methods, processes and deliverables. • Develop best practices, document processes, and operational and procedural improvements. • Identify, define and track QA metrics and KPIs. • Teach teams to develop applicable testing procedures and expectations. • Analyze and assess current QA processes and assist with strategic QA planning. • Initiate, plan, execute, manage and complete QA activities related to complex application and system implementation projects. • Create and maintain test strategies, plans, scenarios and cases. • Coordinate and manage holistic testing efforts for multiple projects and software releases, including integration, system, regression, performance and user acceptance testing. • Document test results, track and manage defects, and troubleshoot issues. • Monitor and communicate QA activity status. • Lead and manage test schedules, environments and configuration requirements for testing activities. • Provide testing estimates for resourcing, levels of effort and timelines. • Establish and manage traceability of requirements through test plans and cases. • Partner with Business Analysts to ensure requirements are met and accurately tested. • Provide input on go / no-go decisions for production releases. • Create, execute and manage manual and automated test cases. • Develop and maintain automated test scripts. • Bachelor's degree in computer science or related technical discipline. • Development background a must. • 10+ years of QA experience in an IT environment. • years experience in automation testing and tools. • Experience with software development life cycle and agile methodology. • Knowledge of QA processes, procedures and systems. • Extensive experience planning, executing and managing integration, system, regression and user acceptance testing. • Ability to manage concurrent projects, activities and tasks under time constraints. • Experience with a variety of technologies, platforms and development languages (AS400, Java, .NET, etc.). • Experience with performance and load testing. • Knowledge of supply chain and logistics preferred. Experience with IBM Rational Team Concert, TFS and JIRA a plus Additional Information Multiple Openings for OPT/CPT/H4/L2/EAD/Citizen's.

A successful ground beef further processing facility located in Kenosha, has an immediate need for a QA Manager. Environment: Departments: Fresh and Frozen Departmental QA and the HACCP / Food Safety policies and processes Techs: Oversee 3 supervisors, 1 clerk, and 16 QA technicians Development and aptitude. Reports: Director of Operations and a dotted line to Corp. Director of QA / Food Safety Special Assigned: Co-Chairs the HACCP team with the Director of Operations. Monthly meetings Wendys, Yum, TOPCO, Siliker, and Cook & Thurber auditing requirements Challenge and evaluate all quality processes in the production areas for consistency. Lead the production departments in answering to customer complaints Has HACCP certification and can audit the plants plan. Handles USDA Food Safety Audits when they arrive. Heads USDA and Weekly meeting Primary duties will include: Overseeing the operation and function of the QA Technicians and Supervisors Maintaining and enforcing programs, procedures, policies and manuals Ensuring the safety and quality of incoming raw materials and outgoing finished products Meet personnel objectives by planning, monitoring, appraising, and reviewing job contributions; providing awareness education, enforcing policies and procedures. Meet operational objectives by providing analysis and insight to strategic planning; creating action plans; implementing quality and food safety standards, identifying and resolving problems; analyzing the results of audits and processing data to identify strengths and weaknesses and identify the path to continuous improvement process. Design and develop SOP's using the principles of HACCP to assure uniformity of purpose. Validate quality processes by reviewing and fine tuning product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; reviewing and critiquing quality assurance procedures. Maintain and improve product quality by analyzing and trending the results of product, plant, regulatory compliance, and third-party audits collaborating with other members of management to study and improve process control. The ideal candidate will have previous quality assurance experience at the managerial level in the meat industry, solid knowledge of USDA regulations and policies, ability to handle customer and global standard audits, verifiable experience in addressing quality and food safety issues from both a corrective and a preventive posture. SPC skills are a plus.

Description We are committed to hiring top talent into our operations teams to deliver world-class services. We look for self-motivated and goal-oriented people eager to learn our trade and be a part of our growing team. We value individuals who are problem solvers, team workers and maintain a bright, positive attitude. If you like a fast-paced work environment to learn lifelong skills, we welcome your completed application. Position Location: 301 Travis Ln, Waukesha, WI 53189 with travel to other ThermTech locations in Waukesha and New Berlin Position Hours: Primarily 8:00 AM - 5:00 PM. Monday - Friday; however, this position must ensure that production functions are maintained 24/7, potentially requiring on-call availability. Position Salary: $85,000 - $140,000 Salaries are based on a number of factors, including the skills and experience of the candidates. It is common to be hired at the lower to middle end of a salary range and while it is possible to be hired at the higher end, it often requires unique circumstances, such as proven expertise. Company Benefits: Health Insurance Dental Insurance 401(k) - Company matched 50% on the 1st 4%. Paid Time Off - Accrued annually with 80 hours for the first year of service 8 Paid Holidays Basic Life and AD&D Insurance at no cost to employee Optional Voluntary Life Insurance Short-Term and Long-Term Disability Plans at no cost to the employee Health Savings Account (HSA) for employees enrolled in ThermTech's Insurance ThermTech provides the opportunity to earn enough HSA funds to offset the deductible of health insurance when employee and spouse (if applicable) have a yearly physical with ThermTech's On-Site Clinic and participate in the Employee Wellness Program. Employee assistance program: Confidential 24/7 support and short-term counseling Tuition reimbursement / Professional development assistance. Other: On-site Clinic services (On-demand Urgent and Primary Care, Virtual Video Visits, Chiropractic Care, and Health Coaching) available to all employees and their family, at no additional costs, even if they are not covered by ThermTech's health insurance. Discounted Standard Process supplements. Free Uniforms, Safety Equipment, and Employee recognition (PIN) program For more information, please visit our website: ***************** : Summary: The Quality Manager position is responsible for the development, maintenance, measurement and communication of all aspects of the quality management system. The position is responsible for managing all quality assurance personnel. The Quality Manager position is responsible for developing and implementing the required internal systems to ensure the organization meets all customer, regulatory and statutory requirements. Job Duties & Responsibilities (Essential Functions): 1. Quality Management System a. Schedule and lead the annual review and approval of all quality management system and quality operating procedures. b. Publish and approve all quality management system documents. c. Ensure the quality management system meets the requirements of ISO 9001 and AS9100. d. Develop the quality management system in order to meet the changing and growing requirements of customers, specifications, and the organization. e. Perform management of change activities to ensure the integrity of the quality management system and the effective roll out of changes to ThermTech personnel. f. Assist in the production of training materials related to the Quality Management System. 2. Management Representative a. Report to top management the health, performance, and need for improvement of the quality management system. b. Promote customer focus and an awareness of meeting customer requirements throughout the organization. c. Ensure actions are implemented to reduce the likelihood of non-conformities. 3. Management Review a. Administrate Quarterly Management Review and Weekly presentations i. Collect data and report the status of all organizational and departmental quality metrics. 4. Audit System a. Internal (First Party) i. Maintain the annual internal audit schedule. ii. Assign internal auditors to ensure auditor independence, iii. Hold opening and closing meetings. iv. Report on audit results b. Customer (Second Party) i. Complete all requested self-audits. ii. Coordinate with the customer to schedule audits (customer requests the audit). iii. Oversee the customer audit and coordinate with ThermTech personnel. c. Accreditation (Third Party) i. Coordinate and schedule accreditation audits. ii. Oversee the audit and coordinate with ThermTech personnel. 5. Champion Continual Improvement a. Create and manage corrective and preventative actions based on the needs of the organization, metrics, and data gathered from audits. 6. Leadership and Management a. Provide leadership and personnel development for relevant teams. The statements herein are intended to describe the general nature and levels of the works performed by employees but are not a complete list of responsibilities, duties, and skills required of personnel so classified. Furthermore, the job description does not constitute a written or implied contract for employment. ThermTech reserves the right to revise or change job duties and responsibilities as the need arises. Minimum Requirements: Applicants must be legally entitled to work in the United States (i.e., a citizen or national of the U.S., a lawful permanent resident, a non-resident, authorized to work in the U.S. without ThermTech sponsorship). ThermTech does not sponsor visas, either at time of hire or at any later time. This position must satisfy ITAR (DSP-5) compliance requirements; therefore, candidates must be a lawful permanent resident [8 U.S.C. 1101(a)(20)] or a protected individual [8 U.S.C. 1324b(a)(3)]. Employment of Foreign Persons(s) [22 CFR 120.63] will be contingent on receiving the DSP-5 license from the US State Department. All hires are contingent upon a 9-panel hair follicle drug test & background check. May be required to obtain and maintain forklift operation certification May be required to work overtime or any shift, including weekends. Physical & Mental Demands: The following physical and mental demands consist of but are not limited to the following: Must be able to work in a standing position for extended periods in a non-climate controlled industrial environment Ability to bend, pull, stoop, and reach to perform functions. Capable of lifting and carrying at least 25-pound objects throughout shift Must be exposed to heat, fumes, noise, humidity, etc. Must have the cognitive and mental capacity to perform essential job functions. Must demonstrate the ability to read, write, and communicate in the English language. Must demonstrate the ability to perform fundamental mathematical skills and concepts (e.g. addition, subtraction, multiplication, division, fractions, decimals, percentages, and the basics of algebra and geometry). Visual acuity to read documents, computer screens, files, etc. Ability to hear in person and via phone. Education: High school diploma or equivalent required Four-year degree in quality management, management or science related field preferred Experience: Experience in creating, managing and implementing quality management systems and procedures that meet specification, regulatory, and organizational needs. Experience as an auditor and auditee. Demonstrated experience crafting Nadcap heat-treat policy and audit exposure strongly preferred. Hard Skills: Capability to lead a team as well as be an effective team member. Ability and confidence to interpret complex specifications and translate into internal policies and procedures. Excellent interpersonal skills. Possess critical evaluation skills. Organize and lead meetings. Soft Skills: Excellent written & verbal communication skills Excellent time management Attention to detail Organized Adaptability Self-motivated Able to work collaboratively with others Willingness to learn & take direction ThermTech does not accept unsolicited resumes from staffing agencies, headhunters, recruiters, and/or placement agencies. Please do not directly contact our executives or managers via email or phone or by other means. Your correspondence will not be returned. All communications of this nature should be directed to *********************. Type: Full-time Pay: $85,000.00 to $140,000.00 per YEAR

Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at contract manufacturing organizations (CMOs In partnership with QC, Regulatory Affairs, Contract Manufacturing and Project Management the QA Manager will ensure that products are manufactured in accordance with cGMPS, regulatory commitments, Assertio requirements and internal procedures. Essential Job Functions * Approve master batch records, specifications, qualification & validation protocols and reports, labels, stability protocols and reports. * Approve/release (or reject) commercial batches. * Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with 21 CFR 211, other applicable regulations and current industry standards. * Approve deviations, ensuring that root cause analysis and corrective actions are adequate. * Audit CMOs, contract test laboratories and/or raw material suppliers. * Manage product complaints according to procedure. * Establish or optimize quality systems. * Perform risk analysis to assess inadvertent events that may impact product identity, strength, quality, purity. * Advise and/or manage risk management strategies. * Author quality agreements and standard operating procedures. * Must be capable of working independently with minimum supervision. * Represent quality management at CMOS. Additional Responsibilities/Duties * Establish/maintain effective working relationship with CMOs/business partners. * Partner with 'CMC' team members to ensure a cohesive unit aligned in expectations for CMO deliverables. * Travel estimated 25% Education and Experience * Bachelor's degree or equivalent experience in related field required * Minimum 7 years' experience in GMP environment with at least 5 years QA experience * Experience with manufacturing commercial pharmaceutical products is required. * Prior experience with outsourced GMP activity and clinical experience strongly desired * Experience with method development and method validations in a QC chemistry and microbiology cGMP Manufacturing environment is desired. * Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required * Experience with combination products a bonus Skills and Abilities * Strong oral and written communication skills * Ability to recognize and accommodate cultural differences in a work environment. * Ability to multitask and prioritize own work schedule. * Computer literate (word, excel, powerpoint, etc.) * Good collaborative skills * Skilled in risk analysis/risk management strategies Physical/Mental Demands * Sitting - 80% * Standing/ walking - 20% * Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures. * Lifting: Raising objects under 40 pounds from a lower to a higher position or moving objects horizontally * Repetitive motion: Substantial movements of the wrists, hands, and/or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day. * Visual Requirements: Able to see and read PC screens and read fine print. * Collaboration: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints. * Decision Making: Ability to make decisions which have impact on the department/company credibility, operations, and services. * Communication: Ability to compose letters, outlines, memos and basic reports, and to orally communicate technical information and to complete forms, use existing form letters and conduct routine oral communication. * Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes. * Comprehension: Ability to understand, remember, and apply oral and/or written instructions or other information. Ability to understand, remember and communicate routine, factual information and to organize thoughts/ideas into understandable terminology. Accommodations for Applicants with Disabilities * Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email ***************** or call ************for assistance.

Responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at contract manufacturing organizations (CMOs In partnership with QC, Regulatory Affairs, Contract Manufacturing and Project Management the QA Manager will ensure that products are manufactured in accordance with cGMPS, regulatory commitments, Assertio requirements and internal procedures. Essential Job Functions Approve master batch records, specifications, qualification & validation protocols and reports, labels, stability protocols and reports. Approve/release (or reject) commercial batches. Provide guidance and make recommendations regarding issues that relate to manufacturing products in accordance with 21 CFR 211, other applicable regulations and current industry standards. Approve deviations, ensuring that root cause analysis and corrective actions are adequate. Audit CMOs, contract test laboratories and/or raw material suppliers. Manage product complaints according to procedure. Establish or optimize quality systems. Perform risk analysis to assess inadvertent events that may impact product identity, strength, quality, purity. Advise and/or manage risk management strategies. Author quality agreements and standard operating procedures. Must be capable of working independently with minimum supervision. Represent quality management at CMOS. Additional Responsibilities/Duties Establish/maintain effective working relationship with CMOs/business partners. Partner with ‘CMC' team members to ensure a cohesive unit aligned in expectations for CMO deliverables. Travel estimated 25% Education and Experience Bachelor's degree or equivalent experience in related field required Minimum 7 years' experience in GMP environment with at least 5 years QA experience Experience with manufacturing commercial pharmaceutical products is required. Prior experience with outsourced GMP activity and clinical experience strongly desired Experience with method development and method validations in a QC chemistry and microbiology cGMP Manufacturing environment is desired. Experience with Quality Management Systems (Trackwise, Veeva, etc.) is required Experience with combination products a bonus Skills and Abilities Strong oral and written communication skills Ability to recognize and accommodate cultural differences in a work environment. Ability to multitask and prioritize own work schedule. Computer literate (word, excel, powerpoint, etc.) Good collaborative skills Skilled in risk analysis/risk management strategies Physical/Mental Demands Sitting - 80% Standing/ walking - 20% Must be able to enter clean room environments and manufacturing areas, and to follow gowning procedures. Lifting: Raising objects under 40 pounds from a lower to a higher position or moving objects horizontally Repetitive motion: Substantial movements of the wrists, hands, and/or fingers for sustained periods of time. Approximately 6-hours of keyboarding per day. Visual Requirements: Able to see and read PC screens and read fine print. Collaboration: Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints. Decision Making: Ability to make decisions which have impact on the department/company credibility, operations, and services. Communication: Ability to compose letters, outlines, memos and basic reports, and to orally communicate technical information and to complete forms, use existing form letters and conduct routine oral communication. Mathematics: Ability to compute, analyze, and interpret numerical data for reporting purposes. Comprehension: Ability to understand, remember, and apply oral and/or written instructions or other information. Ability to understand, remember and communicate routine, factual information and to organize thoughts/ideas into understandable terminology. Accommodations for Applicants with Disabilities Assertio is proud to create a culture of inclusion and diversity and be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. We provide reasonable accommodations to qualified applicants with disabilities and to disabled veterans in accordance with the ADA. If you require a reasonable accommodation for any part of the application process due to a medical condition or disability, please email ***************** or call ************for assistance.

Ocean Spray is hiring for a(n) FSQA Associate Manager! We're a team of farmers, thinkers, creators, and doers. Whatever your title, whatever your role - it always comes back to this: we're a farmer-owned co-op where everyone rolls up their sleeves to get the job done. Three maverick farmers started it all - and we've been making our own way ever since. The Associate Food Safety & Quality Manager will be responsible for directing the implementation of FSQA policies at the assigned plant. You will establish standards for FSQA practices, monitor program performance, and analyze operational data to ensure plant compliance. You will also assist with location audits and visits, serving as an FSQA resource for internal and external partners. Additionally, you will direct FSQA teams in improving Quality procedures and support, coach, and train team members to develop operational excellence. A Day in the Life… • Provides direct leadership and mentoring of the Food Safety and Quality Assurance (FSQA) staff and is responsible for their development and performance. Ability to connect/influence local plant management and plant workforce to drive a best in class Quality Culture. • As a member of the Plant Leadership Team, influence plant leadership to ensure all FSQA programs and systems are implemented effectively. Coach/develop all plant leaders in regard to quality and statistical tools. • Oversees and maintains robust FSQA programs (e.g. HACCP, sanitation, pest control, GMP, traceability, others) in the facility, implementing and ensuring compliance to Government and Ocean Spray Standards. Monitors key quality indicators/metrics, manages continuous improvement reviews and special projects as assigned. • Responsible as Ocean Spray representative to outside governmental agencies, USDA, FDA, State Department of Agriculture, etc. and to consumers and customers through investigation and response to complaints. Leads all visits from external regulatory agencies. • Audit Leadership - Responsible as Ocean Spray representative to customers for their audit requirements of our production facilities and to consultants that are employed for audits. • Manages the investigation of product incidents and consumer complaint at the plant level. Utilizes RCA's and ensures CAPA's are implemented and verified. Empowers direct staff and collaborates with necessary departments to quickly understand issue. • Responsible for ensuring plant sanitation requirements are met. Includes monitoring/auditing effectiveness of cleaning practices using visual and microbiological methods. Requires dotted line relationships to operations resources supervising and performing cleaning tasks. • Sets standards for content of communication materials, distribution, and timeliness in relation to the food safety and quality practices of the Plant. What We Are Looking For: • Bachelor's degree in Biological Sciences, Chemical Sciences, Chemical Engineering, Food Sciences or Science related discipline • 5+ years of managerial experience within manufacturing environment. Progressive food/beverage quality systems experience, including statistical process control (SPC). Experience in a union environment a plus • HACCP Certification. FSMA, PCQI, GFSI certifications preferred • Requires effective leadership, influencing, and interpersonal skills in both the direction/development of subordinates and interaction with external contacts • Must be an effective listener to address the concerns of both internal and external customers. Appropriate business management skills and strong problem-solving abilities are necessary **Education: **Bachelor's or University Degree (Required) **Work Experience: **At least 5 Years of FSQA Leadership Experience Benefits: Complete insurance package on Day-1 that includes a plethora of health and wellness programs- Health, Dental, and Vision insurance Health savings account Flexible spending account Life and accident insurance Employee assistance program Telehealth services Fertility benefits Transgender benefits 1:1 health coaching and more 401(k) with up to 6% Company matching; additional potential discretionary match at year-end Short-Term Incentive/Performance bonuses Flexible scheduling options Vacation pay, up to three weeks of time (pro-rated for your first year of employment) Holiday pay for 12 holidays Career development and growth opportunities Tuition/Education assistance programs Access to LinkedIn Learning Scholarship programs for children of employees Parental leave Bright Horizons Family Solutions - Back-up care, tutoring, etc. Adoption assistance Bereavement leave Up to $300 fitness reimbursement Up to $300 massage reimbursement Employee appreciation events Employee discounts Charitable giving **Who We Are: ** You might have our iconic cranberry juice in your fridge or have gotten into heated holiday debate about what's better - canned or fresh cranberry sauce. But did you know that the hardworking people growing the superfruit in our products are 700 family farmers that own our cooperative? They entrust us with what is most precious to them to create new and innovative products that will delight consumers and grow this beloved brand today and into the future. Team members, farmers, consumers and communities alike--we value what makes us unique and strive to connect our farms to families for a better life by living our values: **G **rower Mindset - We embrace our grower-owners innovative spirit and heritage through confidence, learning and focus on the future. Sustainable **R **esults - Guided by purpose, we are focused on delivering results for our grower-owners. **I **ntegrity Above All - We are ethical, doing the right thing for our grower-owners, customers, consumers and each other Inclusive **T **eamwork - We build diverse and inclusive teams that strengthen our cooperative. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. You should be proficient in: Quality Inspection Experience Supplier Management Food and Beverage Manufacturing Food Safety and Quality Assurance (FSQA) FDA Regulations USDA Regulations Quality Control Experience Salary info: $48.08 - $57.69 / hr

AB2 has an immediate need for a highly analytical and detail-oriented Business Analyst (BA) who will also take on Quality Assurance (QA) responsibilities to join the modernization program for B2C and B2B2C ecommerce business. This hybrid role is ideal for someone who can bridge business needs with technical implementation while ensuring high quality product delivery. The ideal candidate will gather and document requirements, collaborate with cross-functional teams, and perform structured testing to validate solutions before release. This BA/QA hybrid role ensures that business needs are effectively captured and translated into high-quality deliverables. You will play a key role throughout the project lifecycle-from requirement analysis to solution validation-ensuring that both functionality and quality standards are met. Key Responsibilities Business Analysis • Collaborate with business stakeholders to gather, analyze, and document business requirements, processes, and workflows. • Translate business needs into clear and detailed functional specifications and user stories. • Facilitate requirement-gathering workshops, interviews, and meetings. • Create process maps, data flow diagrams, and use cases. • Support product owners in backlog refinement and prioritization. • Ensure requirements are understood by the development team and aligned with business goals. Quality Assurance • Develop test strategies, test plans, and test cases based on requirement documents and user stories. • Execute functional, regression, system, integration, and user acceptance testing. • Log, track, and validate bug fixes; work closely with developers to ensure resolutions are delivered. • Perform data validation and API testing where applicable. • Participate in sprint ceremonies (planning, stand-ups, reviews, retrospectives) as both BA and QA. • Ensure delivered features meet acceptance criteria and quality standards before deployment. Qualifications • Bachelor's degree in Business, Information Systems, Computer Science, or related field. • 2-5 years of experience as a Business Analyst, Quality Assurance Analyst, or hybrid BA/QA role. • Strong understanding of SDLC, Agile methodologies, and requirements management. • Experience creating user stories, acceptance criteria, and process documentation. • Hands-on experience with QA tools such as Jira, Playwright, Postman. • Excellent analytical, communication, and problem-solving skills. • Ability to manage multiple tasks and work effectively in a fast-paced environment. Preferred Skills • Experience in the modernization program for B2C and B2B2C ecommerce business • Experience in Agile/Scrum environments. • Basic understanding of SQL for data validation. • Familiarity with automation testing. • Domain knowledge of healthcare, e-commerce. Soft Skills • Strong attention to detail. • Ability to communicate with both technical and non-technical stakeholders. • Proactive approach to identifying issues and recommending improvements. • Critical thinker with strong organizational skills.

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Analyst in our Libertyville, IL location is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, and/or ISO 11137 and other applicable regulatory standards. In this role the Quality Analyst will lead complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. You will execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. As a Quality Analyst you will also support production and quality operations by coordinating and performing problem-solving investigations, reviews and final acceptance/run release of processing runs that contain non-conformances. Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting. This position requires working onsite in our Libertyville, IL location Monday through Friday 8:00am to 4:30pm with occasional earlier or later hours based on business needs. What You'll do as a Quality Analyst * Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight. * Responsible for oversight of all product and/or report review and release conducted by Quality Technicians/Senior Quality Technicians. * Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations. * Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities. * Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit observations assigned by site Quality Manager. * Manage creation of new quality system policies and procedures and revisions to existing policies/procedures. * Review collected data to perform statistical analysis and recommend process changes to improve quality. * Monitor and report on performance metrics. * Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. * Collaborate with other departments and facilities within the company on quality related issues. * Lead quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc.). * Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations. * Perform other duties as assigned. The Experience, Skills and Abilities Needed Required: * Bachelor's degree in Scientific or related technical field. * Minimum of 1 year of combined Manufacturing/Quality Engineering and/or Quality Systems experience. * Minimum of year of experience working in an ISO certified environment required. Preferred: * Minimum of year of experience with medical device or other regulated industries preferred (ISO 13485). * Working knowledge of FDA QSR/ EUGMP regulations strongly preferred. * Working knowledge of ISO/IEC 17025 regulations. Other: * Excellent problem-solving skills * Focus on identification of potential issues and continuous improvement. * Experience working on cross-functional teams and on own initiative. * Demonstrated excellent organizational, oral and written communications skills. * Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint. * Ability to work in a fast-paced, regulated environment with strict deadlines. * Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra. What STERIS offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Here is just a brief overview of what we offer: * Market Competitive pay * Extensive Paid Time Off and added Holidays * Excellent Healthcare, Dental and Vision benefits * Long- and Short-Term Disability coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add- on benefits / discounts for programs such as Pet Insurance * Tuition Reimbursement and continuing education programs * Excellent opportunities for advancement in a stable long-term career #LI-MO1 #LI- Onsite Pay range for this opportunity is $75,000 to $82,000, depending on skillset and experience. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

Join a dynamic, growing organization where your contributions will be recognized and your talents will continue be enriched and rewarded. This position oversees the Quality function at both of our production facilities, McHenry and Lake Bluff and reports directly to the Vice President of Operations. JOB DESCRIPTION Title Quality Assurance Manager FLSA Exempt POSITION SUMMARY This position is Jessup Manufacturing's “Champion of Quality”. Manages enterprise wide QMS including ISO 9001 and any future quality or environmental standards. Leads continuous improvement efforts focused on prevention to improve quality and profitability. RESPONSIBILITIES Manages Quality Assurance Technicians to support enterprise-wide production functions. Manages all phases of ISO 9001 Quality Management System (QMS) including documentation, implementation, audits and management review. Uses Key Process Indicators (KPI”S) and internal audits to prioritize areas for improvement through Root Cause Analysis and Permanent Corrective Actions. Tracks and reports Quality KPIs Represents, maintains, and coordinates documentation and audits for 3 rd party certifications (UL, MED, FM, NEMO) Develops and implements employee training to achieve quality improvement goals. Supports Product Development and Manufacturing to develop, communicate, and maintain product and manufacturing specifications. Teams with sales and customer support to ensure customer inquiries regarding product performance and tolerances are answered accurately and promptly. Owns the Customer Complaint process including validation, reporting and resolution. This will include direct contact with Sales, Manufacturing, suppliers and customers. Develops and maintains all testing, documentation, and quality procedures for incoming, in process and final inspection. Drives Nonconforming Material process at all levels of manufacturing. Drives incoming non-conforming material process including documentation, containment, Supplier Corrective Action and verification of effectiveness. Coordinates RMA's and debit memos for produced and purchased materials. Leads Material Review Board (MRB) to disposition all quarantined and returned materials. Maintains all Corrective Action Records (CAR's). Oversees evaluation and implementation of CAR's, and monitors CAR's effectiveness. Completes control plans, PPAP, FMEA, FAI and gauge R&R as required. Implements supplier incoming quality requirements. Manages test equipment control and calibration processes. Owns Jessup Manufacturing's Environmental Health and Safety (EHS) program. Lead Safety Committee meetings. Represent Jessup for OSHA or related visits and coordinate response to OSHA inspections and findings. Manage safety audits. Document, maintain, and implement safety policies. Coordinate required safety training, including new employee, recurring training, and introducing new topics. Makes suggestions to improve quality, efficiency, safety, and communication, and encourages all employees to do the same. Travels between production facilities as expected. Limited travel to suppliers, outside service providers and customers will be expected. Other Duties as required. EDUCATION & EXPERIENCE Bachelor's degree in chemistry, engineering, or equivalent. Minimum of 3 - 10 years' experience in managing multi-plant ISO Certified Quality Systems. Proven leadership of Lean Manufacturing / Continuous improvement initiatives. Background in PSA coating, converting and printing preferred. Management of EHS systems preferred. SKILLS Ability to manage cross-functional teams to effectively bring solutions to quality issues. Strong problem-solving skills. Knowledge of quality reporting and techniques including SPC, PPAP, FMEA, FAI and Gauge R&R. Excellent presentation, verbal and written communications skills. Excellent analytical, organizational and computer skills.

At Origin Specialty Underwriters, a Beyond Risk Management affiliate company, we are a dynamic and growing insurance MGA known for our specialized expertise and strong client relationships. We value honesty, integrity, and excellence above all else. We've developed bespoke, end-to-end solutions that will foster long-term relationships regardless of market conditions. We are seeking a detail-oriented and proactive Quality Assurance (QA) Manager who will be responsible for overseeing and enhancing the effectiveness, consistency, and compliance of the claims handling function. This role ensures that claim administration processes meet regulatory, contractual, and organizational standards, while driving continuous improvement through audits, training, and process innovation. The QA Manager will also play a key role on the claims management team, contributing to department strategy and performance. Key Responsibilities: Claims Auditing: Conduct regular audits of claim files to assess compliance, accuracy, timeliness, and quality of handling Develop and maintain audit protocols, scoring methodologies, and reporting tools Provide feedback and actionable recommendations to adjusters and management Process Improvement: Evaluate existing claim administration processes for efficiency, accuracy, and compliance Recommend and implement improvements to workflows, documentation standards, and procedures Partner with claims leadership to align process changes with departmental goals Training & Development: Design and deliver training programs for adjusters and claims staff to improve technical expertise, compliance awareness, and service delivery Identify skill gaps and provide targeted coaching and resources Track and measure the effectiveness of training initiatives Technology & Workflow Optimization: Collaborate with IT and system vendors to enhance claim management system functionality Identify opportunities for automation, workflow efficiency, and user-friendly system improvements Support testing and implementation of system upgrades and enhancements Audit & Compliance Coordination: Serve as primary liaison for audits conducted by carriers, brokers, insureds, and other external partners Ensure timely responses to audit requests and oversee corrective action plans where required Maintain awareness of regulatory and contractual compliance requirements impacting claims handling Team Participation & Leadership: Actively contribute as a member of the claims management team, providing insights and recommendations on strategy, performance, and operational improvements Prepare and present quality assurance reports and metrics to leadership Promote a culture of continuous improvement, accountability, and customer focus within the claims department Qualifications: Bachelor's degree in Business, Insurance, Risk Management, or related field (preferred) 7+ years of claims handling experience, including supervisory or quality assurance responsibilities Strong knowledge of claims processes, compliance requirements, and best practices Proven experience in auditing, training, and process improvement Proficiency with claim management systems and MS Office Suite; experience with system workflow design a plus Excellent communication, analytical, and problem-solving skills Ability to manage multiple priorities and collaborate effectively across teams Key Competencies: Detail-oriented with strong analytical and organizational skills Effective communicator with ability to deliver constructive feedback Skilled in coaching, mentoring, and staff development Continuous improvement mindset with ability to drive change Strong collaboration and relationship-building skills If you're ready to make an impact and grow your career in a dynamic, forward-thinking company, we'd love to hear from you! Apply today to join our team. As our company continues to grow at a rapid pace, so do the opportunities for our current and future employees. Origin Specialty is an equal opportunity employer.

Baker Tilly is a leading advisory, tax and assurance firm, providing clients with a genuine coast-to-coast and global advantage in major regions of the U.S. and in many of the world's leading financial centers - New York, London, San Francisco, Los Angeles, Chicago and Boston. Baker Tilly Advisory Group, LP and Baker Tilly US, LLP (Baker Tilly) provide professional services through an alternative practice structure in accordance with the AICPA Code of Professional Conduct and applicable laws, regulations and professional standards. Baker Tilly US, LLP is a licensed independent CPA firm that provides attest services to its clients. Baker Tilly Advisory Group, LP and its subsidiary entities provide tax and business advisory services to their clients. Baker Tilly Advisory Group, LP and its subsidiary entities are not licensed CPA firms. Baker Tilly Advisory Group, LP and Baker Tilly US, LLP, trading as Baker Tilly, are independent members of Baker Tilly International, a worldwide network of independent accounting and business advisory firms in 141 territories, with 43,000 professionals and a combined worldwide revenue of $5.2 billion. Visit bakertilly.com or join the conversation on LinkedIn, Facebook and Instagram. Please discuss the work location status with your Baker Tilly talent acquisition professional to understand the requirements for an opportunity you are exploring. Baker Tilly is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, gender identity, sexual orientation, or any other legally protected basis, in accordance with applicable federal, state or local law. Any unsolicited resumes submitted through our website or to Baker Tilly Advisory Group, LP, employee e-mail accounts are considered property of Baker Tilly Advisory Group, LP, and are not subject to payment of agency fees. In order to be an authorized recruitment agency ("search firm") for Baker Tilly Advisory Group, LP, there must be a formal written agreement in place and the agency must be invited, by Baker Tilly's Talent Attraction team, to submit candidates for review via our applicant tracking system. Job Description: Are you looking for an accounting role to launch your career? Do you want to work with privately held and publicly traded companies that occupy all stages of development? As an Assurnace Associate at Baker Tilly (BT), you will be a value architect delivering audit and other assurance services to clients. As one of the fastest growing firms in the nation, BT offers you upward career trajectory, flexibility in how and where you get your work done and meaningful relationships with clients, teammates and leadership who truly care about you and your development. You will enjoy this role if you: Desire to become a trusted business advisor, working face-to-face with clients to find creative solutions to complex accounting and business challenges Want to work for a leading CPA advisory firm whose owners have both their clients' and employees' best interests in mind and are transparent in their decisions Value your development and want to work for a firm that provides a great work environment (ask us about My Time Off, My Development and Dress for Your Day!) Want to grow professionally and develop your client service and technical accounting skills to build a career with endless opportunities now, for tomorrow You will have the opportunity to: Be a trusted member of the engagement team providing various assurance and consulting services: Proactively engage with your clients throughout the year to gather needed information to complete testing and respond to questions raised Perform substantive testing on client's balance sheets and income statements Test for deficiencies of internal controls and discussing recommendations for improvement Learn and grow from direct on-the-job coaching and mentoring along with participating in firm wide learning and development programs Utilize your entrepreneurial skills to network and build strong relationships internally and externally with clients Build friendships and strong work relationships while gaining valuable experience Qualifications Successful candidates will have: Bachelor's or master's degree in accounting or a related degree in business, with sufficient course work and credits to sit for the CPA exam in the state you are being considered Outstanding academic performance required, with a preferred GPA of 3.0 or above Relevant internship, work experience and/or involvement with a professional organization The ability to work effectively in a team environment with all levels of client personnel Demonstrated skills in the areas of time management, communication, interpersonal skills, relationship building, collaboration, and problem solving Organizational and analytical skills, initiative, adaptability Proficiency with Microsoft programs (Word, Excel, PowerPoint, etc.) There is currently no immigration sponsorship available for this position

This role is responsible for reviewing and assessing the medical suitability of human cardiovascular tissue donors for transplant. The position ensures compliance with FDA regulations, AATB standards, Good Tissue Practices, and the company's Quality Management System. Responsibilities Conduct comprehensive quality reviews of all records generated during tissue recovery, processing, cryopreservation, labeling, storage, and distribution, ensuring accuracy and completeness. Evaluate medical documentation, including donor charts, autopsy reports, EMS records, serology, and culture reports, to determine donor eligibility and medical suitability for transplant. Engage with recovery partners and other stakeholders to request clarifications, obtain additional documentation, and resolve discrepancies in donor records. Ensure adherence to the company's Quality Management System (QMS), FDA 21 CFR Part 1271 Good Tissue Practices, AATB standards, and internal policies and procedures. Identify and escalate issues that may impact compliance, safety, or product quality, providing input to management for investigation, corrective actions, and process improvements. Collaborate with cross-functional teams to streamline workflows, improve record accuracy, and enhance operational efficiency. Perform additional responsibilities as assigned by management to support departmental and organizational objectives. Qualifications High School diploma. LPN, RN, or BSN related clinical experience preferred. Minimum of 2 years' experience in quality assurance or a regulated healthcare/biotech environment preferred. Experience reviewing medical records, donor charts, or clinical documentation a plus. Knowledge of FDA regulations (21 CFR Part 1271), AATB standards, and Good Tissue Practices is highly desirable. Strong analytical and problem-solving skills, with the ability to make informed decisions and escalate issues appropriately. Excellent oral and written communication skills, with the ability to collaborate effectively with internal teams, external partners, and regulatory stakeholders. Flexible, adaptable, and open to change, with a demonstrated willingness to accept responsibility and drive process improvements. EEO Statement In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training. Applicants with disabilities may contact LeMaitre HR coordinators via telephone, fax, e-mail, and other means to request and arrange for accommodations. If you need assistance to accommodate a disability, you may request an accommodation at any time. Please contact LeMaitre HR at ***************.