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Quality assurance manager jobs in Kokomo, IN

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  • Senior Quality Assurance Manager

    Harba Solutions Inc.

    Quality assurance manager job in Indianapolis, IN

    JobResponsibilities Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485, FDA, and other applicable regulations. Lead, mentor, and manage a team of quality assurance professionals. Oversee internal and external audits, including preparation, execution, and corrective action follow-up. Review and approve quality documentation, including SOPs, batch records, CAPAs, and deviation reports. Collaborate with R&D, Manufacturing, Regulatory, and Operations teams to ensure product quality from development to commercial release. Monitor key quality metrics and drive continuous improvement initiatives. Ensure timely response to customer complaints, non-conformances, and regulatory inspections. Lead risk management initiatives and support product change controls. Qualifications Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred. 8+ years of experience in quality assurance, with at least 3 years in a leadership role within the medical device, pharmaceutical, or biotech industry. In-depth knowledge of FDA, ISO 13485, and other applicable quality regulations. Strong leadership, coaching, and team development skills. Excellent analytical, problem-solving, and communication skills. Proven experience with audits, CAPAs, risk management, and compliance documentation.
    $91k-136k yearly est. 4d ago
  • Associate Director Quality Assurance

    Astrix 4.1company rating

    Quality assurance manager job in Indianapolis, IN

    Looking for a Pharmaceutical leadership role where you can shape quality operations, build strong teams, and influence the direction of a fast-growing organization? This opportunity is ideal for someone who thrives in startup or scale-up environments and enjoys creating structure, elevating standards, and driving continuous improvement. Pay: $140k-$160k Schedule: 1st shift Type of Job: Direct Hire Location: 100% On-site (Indianapolis area) At this time, Astrix cannot transfer nor sponsor a work Visa for this position. Relocation assistance is not available for this position. Associate Director, Quality & Compliance: Daily Tasks: What you will do: Responsible for the oversight of the QA teams responsible for supporting all production/processing areas. Leads investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation. Responsible for QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports. Contributes in Regulatory/FDA inspections and audits by providing information or obtaining information required by the auditors. Performs review of root-cause analysis and ensures completeness, accuracy and compliance of all documentation. Develops and observes appropriate KPI's for batch documentation review and support of timely batch release. Accountable for the QA department planning, talent development, and budget administration. Associate Director, Quality & Compliance Qualifications/Requirements: Bachelor's Degree is required 6+ Years of progressive QA/QC experience 3+ years in a managerial role in a pharmaceutical or regulated industry We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
    $140k-160k yearly 1d ago
  • Senior Quality Assurance Specialist

    I-Pharm Consulting

    Quality assurance manager job in Indianapolis, IN

    Job Title : HVAC/Piping QA Field Specialist Site : Lebanon, Indiana W2 contract + expenses covered 12 month contract with strong extension potential Overview of the role: Field based QA role focused on HVAC piping systems. This role is primarily about HVAC piping quality and field execution. Approximately ten percent of the scope involves hygienic piping. Daily GEMBA style walkdowns with a strong emphasis on site safety. Key responsibilities: Walk the site daily to support safety quality and construction progress. Oversee HVAC piping quality and field activities. Support system startup including balancing and system cleaning. Manage phased transitions from temporary to permanent utilities. Support engineered temporary utilities using full P & ID documentation. Help ensure smooth transitions while protecting the project schedule. Background Required: Strong experience in HVAC piping QA or field engineering. Exposure to life sciences environments beneficial but not required. Comfortable working fully on site in a live construction setting.
    $69k-90k yearly est. 3d ago
  • Manual QA

    Anchor Point Technology Resources 3.9company rating

    Quality assurance manager job in Indianapolis, IN

    Responsibilities Strong skills in test planning and traceability for compliance and audit purposes. Lead with curiosity to further requirements discussions and uncover test scenarios. Review requirements and specifications to ensure testability. Ability to identify critical business workflows and ensure they remain intact after changes. Develop and maintain manual test cases based on functional requirements and acceptance criteria. Execute manual tests and document results. Log and track defects using appropriate tools. Perform regression testing after bug fixes and new feature deployments. Collaborate with developers, product owners, and other stakeholders to clarify requirements. Participate in test planning and estimation. Ensure quality standards are met before release. Provide clear and detailed defect reports and communicate effectively with the team. Contribute to continuous improvement of Agile and QA processes. Required Skills Strong understanding of software testing methodologies (functional, regression, smoke). Ability to create, execute, and maintain test cases and test plans. Familiarity with bug tracking tools (Azure DevOps, Jira). Strong knowledge of SDLC and Agile methodologies. Strong analytical and problem-solving skills. Excellent written and verbal communication for reporting defects and collaborating with teams. Ability to ask 'Why' and 'What If' questions to enhance discussion and discovery. Attention to detail and ability to identify edge cases. Hands on experience with API testing (using tools like Postman is a plus). Hands on experience with SQL and database queries. Experience with large-scale regression suites. Ability to prioritize test cases for high-risk areas. Knowledge of impact analysis for upgrades and migrations. Ability to coach others and create a testing mindset. Ability to work in a team environment. Ability to self-organize and prioritize tasks within multiple teams. Preferred Skills Knowledge of version control systems (e.g., Git). Understanding of server architecture (Windows). Familiarity with cloud platforms (Azure). Ability to validate configuration changes and deployment impacts. Awareness of test automation frameworks (Selenium, Cypress, Playwright) - even if not hands-on yet. Ability to learn and adapt to automation tools and scripting. Strong analytical thinking for identifying automation opportunities. Education Bachelor's degree in Computer Science, Information Technology, or related field. Equivalent experience in QA/testing may be considered in lieu of formal education. Certifications (Preferred but not mandatory) ISTQB Foundation Level (preferred) Any Agile or Scrum certification (e.g., Certified Scrum Tester). Experience 4+ years of experience
    $50k-79k yearly est. 2d ago
  • Supplier Quality Specialist

    Net2Source (N2S

    Quality assurance manager job in Indianapolis, IN

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

    Clayco 4.4company rating

    Quality assurance manager job in Indianapolis, IN

    About Us Clayco is a full-service, turnkey real estate development, master planning, architecture, engineering, and construction firm that safely delivers clients across North America the highest quality solutions on time, on budget, and above and beyond expectations. With $7.6 billion in revenue for 2024, Clayco specializes in the "art and science of building," providing fast track, efficient solutions for industrial, commercial, institutional, and residential related building projects. The Role We Want You For The Quality Control Manager will be involved in the implementation, oversight, and management of all aspects of Quality Control program, the management and coordination of all documentation performed by testing personnel and any other inspection personnel required by contract, within the Life Sciences/Biotech/Pharmaceuticals sector. The role includes direct oversight and review of the entire documentation and physical inspection phase of the workflow process and working with other in-house personnel to include Project Managers, Superintendents, and external personnel to produce and document a quality product. The Specifics of the Role Coordinate, document, and track preparatory, initial, and follow-up inspections. Chair, plan and schedule the weekly QC meetings with the superintendent and provide written reports as described Provide daily QC reports that reinforce activities that are being constructed in conformance with each specific project's established standard. Collaborate with the project team to develop and establish the Quality Program. Provide ongoing status updates to executive management with recommendations for dealing with substandard performance and overall progress on quality goals. Manage and support respective quality teams in implementing the quality program. Identify the appropriate standards and procedure to be used for a specific task. Communication to the Enterprise regarding best practices, lessons learned, recent events and training opportunities. Drive implementation of the Quality Program on projects, focusing on core programs including Site Specific Quality Plans, policies, and procedures on project through proactive planning, training, support and sharing lessons learned. Manage verification and documentation is being done for all materials received for the project are in conformance with the approved submittal, are handled and stored appropriately and are acceptable for use in the project. Be involved with pre-construction meetings with new and existing subcontractors and the superintendent prior to the start of each new phase of the work to discuss issues that affect quality. Track construction deficiencies and ensure timely implementation of, and verify, all approved corrective actions. Help coordinate and document the testing and commissioning of building systems, review results, and submit. Assist project team to ensure subcontractor compliance to Project Site Specific Safety Plan and perform safety inspections and audits as required by Company practices. Skilled at maintaining and documenting conformance to developed quality plan. Able to monitor/manage deficiencies to quality plan and work to completion. Understands and monitors testing and inspection process. Maintains a positive relationship with those agencies. Able to identify the accuracy of subcontractor work. Understand inspection requirements by city, county, and state to receive TCO & CO. Requirements Bachelor's Degree in Industrial Engineering, Industrial Technology, Construction Management, or related degree, or relevant work experience considered in lieu of education. 5-15 years of progressive experience in construction, demonstrating increasing responsibility and expertise over time. Strong analytical and problem-solving skills with attention to detail. Ability to walk a job site and climb ladders. Some Things You Should Know Our clients and projects are nationwide - Travel will be required. No other builder can offer the collaborative design-build approach that Clayco does. We work on creative, complex, award-winning, high-profile jobs. The pace is fast! This position is classified as a safety-sensitive role in accordance with applicable state and federal laws. Candidates selected for this position will be subject to a comprehensive background check, which includes mandatory drug testing. Why Clayco? Best Places to Work - St. Louis Business Journal, Los Angeles Business Journal, Phoenix Business Journal. ENR - Top Midwest Contractors (#1), Top Design Build Contractors (#4), Top 400 Contractors (#20), ENR - Top Green Builders (#5). Benefits Discretionary Annual Bonus: Subject to company and individual performance. Comprehensive Benefits Package Including: Medical, dental and vision plans, 401k, generous PTO and paid company holidays, employee assistance program, flexible spending accounts, life insurance, disability coverage, learning & development programs and more! Compensation The salary range for this position considers a wide range of factors in making compensation decisions including but not limited to: Education, qualifications, skills, training, experience, certifications, internal equity, and location. Compensation decisions are dependent on the facts and circumstances of each case.
    $70k-98k yearly est. 2d ago
  • Traveling Quality Manager

    Bowen 4.6company rating

    Quality assurance manager job in Indianapolis, IN

    The primary function of this role is to support the Quality Management System with development and implementation of quality procedures, processes, metrics, audits, and training to improve project quality by recommending correct construction methods to subcontractors and company personnel prior to installation and during installation; identify substandard work; and remedy corrective action during construction. The person in this role will have extensive travel and ensure that all products and services meet requirements through being an integral part of the construction process by means of coaching, educating, and mentoring. PRIMARY DUTIES AND RESPONSIBILITIES: Responsible for promoting a safe working environment and setting an example for field personnel. Conducts periodic Safety Observations and report findings to Site Safety Staff Develop a good working relationship with project team (management and field). Develop a good working relationship with job inspectors/owners. Assist/direct project team in proper storage requirement procedures for all onsite materials. Assist/direct project team in proper maintenance requirements for all onsite equipment. Assist/conduct pre-pour conferences/meeting with site teams and clients. Assist/direct setup and success of field and shop welding activities. Assist/direct project team in the collection, tracking and filing the required data to ensure compliance with governing specifications/codes. Create turnover packages. Job specific pre-pour checklist Maintenance logs including: Rotation Logs Lubrication Logs Become a SME related to Division 3 specifications. When specifications are not met, work with the project team and owner to develop a solution. Conduct random audits, as specified by the Corporate Office, for compliance and adherence to BEC's Quality Program. Utilize the data collected from these audits to assist field operations in determining appropriate improvements. Assist Corporate Quality Manager in the development and revision of BEC's Quality Program Conduct source inspections of vendors and subcontractors Ensure vendors and subcontractors are in compliance with project specifications. Assist with bid documents and provide recommendations to estimating and project team that comply with BEC's Program, client requirements, manufactures recommends and applicable Code. Responsible for educating project team. Inspect and document welding activities. Witness and document testing activities Example - 3rd party testing, NDE Complete daily and monthly reports. Submit monthly reports NLT the last working day of the month. Complete Non-Conformance Reports (NCR's) as required and assist team with Quality Short creation. ESSENTIAL SKILLS AND EXPERIENCE: BS in Engineering, Construction Management, or Industrial Technology - preferred Strong written and verbal communication skills. Previous experience working with project teams, subcontractors, and owners/clients. Must be able to interpret construction documents. Previous experience researching corrective options and ability to make recommendations. NACE, API, ACI, ASME, ASNT and other certification - preferred BOWEN BENEFITS: Competitive Base Salary + Company Truck + Annual Bonus Medical, Dental and Vision Insurance PTO from Day 1 7 Paid Holidays (plus 6 additional half-days), 1 Community Day, 1 Floating Holiday Paid Parental Leave Annual Discretionary Bonuses Employer-paid Life Insurance with supplemental options 401k with Company Match HSA and FSA options Employee Referral Program Wellness Program Employee Assistance Program (EAP) Short and Long-Term Disability Family Planning and Adoption Assistance Education Reimbursement
    $53k-82k yearly est. 4d ago
  • Director, Parenteral Sterility Assurance

    Eli Lilly and Company 4.6company rating

    Quality assurance manager job in Indianapolis, IN

    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
    $133.5k-246.4k yearly Auto-Apply 32d ago
  • Quality Assurance Director

    450&&Polarson74

    Quality assurance manager job in Indianapolis, IN

    QA Director Job Responsibilities: Assures quality products and processes by establishing and enforcing quality standards and testing materials and products. Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers. Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures. Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures. Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures. Institutes rework standards by devising inspection and physical testing methods and procedures. Creates product quality documentation system by writing and updating quality assurance procedures. Maintains product quality by enforcing quality assurance policies and procedures and government requirements. Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods. Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends. Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results. Develops a quality assurance staff by recruiting, selecting, orienting, and training employees. Manages quality assurance staff job results by coaching, counseling, and disciplining employees. Ensures quality by planning, monitoring, and appraising job results. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. Achieves financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, and initiating corrective actions. Contributes to team effort by accomplishing related results as needed. QA Director Qualifications/Skills: Leadership Strong written and verbal communication skills Analytic skills Collaboration skills Product management skills QA process skills Computer knowledge and skills
    $98k-152k yearly est. 60d+ ago
  • Director of Quality Assurance

    Vitacyte

    Quality assurance manager job in Indianapolis, IN

    VitaCyte is a leading manufacturer of purified-defined bacterial collagenase and associated protease enzymes for enzyme-mediated cell isolation and other biotherapeutic applications. The company received ISO 9001:2015 certification in 2025 and has established a Quality Management System (QMS) compliant with ISO 9001 and industry standards and regulations. Job Purpose Maintain the QMS to ensure compliance with ISO 9001 and applicable regulatory standards in a state of inspection readiness. Duties & Responsibilities Ensures VitaCyte personnel comply with an ISO 9001 certified QMS and applicable regulatory requirements. Draft, revise, and maintain all controlled policies and procedures comprising the QMS Rigorously review all manufacturing batch records and quality control results to ensure completeness and compliance with quality standards and established specifications Review corrective and preventative root cause investigations; evaluate effectiveness Establish maintenance, calibration, qualification, and cleaning requirements for equipment and instruments to ensure compliance with ISO and cGMP requirements Prepare and approve all validation and qualification plans Facilitate internal audits and correct instances of non-conformance Review and maintain current training records for each individual and role Approve the qualification of all suppliers Qualifications Education/Experience BA/BS, MS, PhD. degree in a relevant field (Biological science, chemistry, engineering, business operations) Minimum 3-years experience working with a quality management system Minimum 5 years direct experience in manufacturing biological products Knowledge of applicable standards and regulations (ex. ISO 9001, ICH Q7, 21 CFR Part 210/211) Maintaining ISO certification is preferred. Experience with eQMS and/or CMMS software preferred. Auditing experience preferred. Skills/Abilities Proven expertise in concepts and methodologies of QA Detail-oriented, organized and attentive to analyzing processes with the ability to identify trends, problems, or opportunities for potential improvements Extensive experience in QMS or regulatory compliance Strong interpersonal skills with a desire and ability to work in interdisciplinary teams Proficiency with Microsoft Excel, Word, and Outlook Benefits Full-time, permanent position including a comprehensive family medical benefit package and participation in an employer-matched 401K plan. Salary is commensurate with experience.
    $98k-152k yearly est. 59d ago
  • Director of Quality Assurance

    Vitacyte LLC

    Quality assurance manager job in Indianapolis, IN

    Job Description VitaCyte is a leading manufacturer of purified-defined bacterial collagenase and associated protease enzymes for enzyme-mediated cell isolation and other biotherapeutic applications. The company received ISO 9001:2015 certification in 2025 and has established a Quality Management System (QMS) compliant with ISO 9001 and industry standards and regulations. Job Purpose Maintain the QMS to ensure compliance with ISO 9001 and applicable regulatory standards in a state of inspection readiness. Duties & Responsibilities Ensures VitaCyte personnel comply with an ISO 9001 certified QMS and applicable regulatory requirements. Draft, revise, and maintain all controlled policies and procedures comprising the QMS Rigorously review all manufacturing batch records and quality control results to ensure completeness and compliance with quality standards and established specifications Review corrective and preventative root cause investigations; evaluate effectiveness Establish maintenance, calibration, qualification, and cleaning requirements for equipment and instruments to ensure compliance with ISO and cGMP requirements Prepare and approve all validation and qualification plans Facilitate internal audits and correct instances of non-conformance Review and maintain current training records for each individual and role Approve the qualification of all suppliers Qualifications Education/Experience BA/BS, MS, PhD. degree in a relevant field (Biological science, chemistry, engineering, business operations) Minimum 3-years experience working with a quality management system Minimum 5 years direct experience in manufacturing biological products Knowledge of applicable standards and regulations (ex. ISO 9001, ICH Q7, 21 CFR Part 210/211) Maintaining ISO certification is preferred. Experience with eQMS and/or CMMS software preferred. Auditing experience preferred. Skills/Abilities Proven expertise in concepts and methodologies of QA Detail-oriented, organized and attentive to analyzing processes with the ability to identify trends, problems, or opportunities for potential improvements Extensive experience in QMS or regulatory compliance Strong interpersonal skills with a desire and ability to work in interdisciplinary teams Proficiency with Microsoft Excel, Word, and Outlook Benefits Full-time, permanent position including a comprehensive family medical benefit package and participation in an employer-matched 401K plan. Salary is commensurate with experience.
    $98k-152k yearly est. 29d ago
  • Quality Assurance and Compliance Manager

    Barnhart Crane & Rigging 4.7company rating

    Quality assurance manager job in Lebanon, IN

    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
    $60k-91k yearly est. 60d+ ago
  • SAP Quality Management/Manufacturing Manager - Chemicals Industry

    Accenture 4.7company rating

    Quality assurance manager job in Carmel, IN

    We Are: Are you ready to step into the heart of digital transformation in one of the world's most critical - and most dynamic - industries? The Chemicals Industry is evolving at lightspeed: demand for sustainability-driven products is on the rise. At the same time, digital platforms, real-time analytics, AI, and SAP-enabled processes are no longer "nice to have" - they are foundational. As part of Accenture's SAP Chemical's Practice, you'll be delivering major SAP engagements (for example, Business Transformation Strategy & Roadmaps, migrations to SAP S/4HANA, process standardization, cloud-enablement) that help clients win in this new environment and guide major Chemical clients through the journey of business-model reinvention, process excellence and enterprise technology enablement You Are: Do you have a passion for storytelling and for originating, selling and delivering SAP-based Supply Chain Transformation projects that make a positive impact in your clients' business? Are you inspired by working with the best companies in their industries? Want a role that provides you with a sense of purpose and satisfaction? Then join Accenture and build a rewarding career improving the way the world works and lives, as you help clients innovate with leading-edge SAP and Accenture Supply Chain solutions and technologies on some of the most innovative projects in the world You will thrive in our highly collaborative, digitally-driven and innovation-led environment while nurturing your talent for thoughtful and game changing solutions in our inclusive culture that values diversity of ideas, experiences and backgrounds. Ultimately, you are a confident manager who spots and stays ahead of the SAP platform, industry and Supply Chain trends and knows how to translate client goals into clear and actionable outcomes that everyone can get behind. You know how to fully utilize the capabilities of various SAP platforms to drive business value, transform end-to-end functions and drive leading practices for your clients in markets all over the globe. The more complex their challenges, the more excited you are about leading the charge to solve them. The Work: Team with clients on their SAP functional transformation programs through your combined SAP application and functional process expertise which includes your ability to: + Engage with client executives on the business challenges/trends and the potential value of SAP solutions (current & future) + Lead customers in defining their SAP journey through the development of business cases & roadmaps including during sales origination, proposal development and client presentations + Architect E2E solutions that leverage SAP technologies, custom apps, & add on partner solutions + Advise, design and deliver solutions based on the latest industry and technology best practices leveraging a SAP solutions and embedded innovation. + Lead small teams - helping them achieve transformational roadmaps - onsite with clients or within Accenture + Become a trusted expert and advisor to your clients, team, and Accenture Leadership by staying current on regulations, trends, and innovations across your area of expertise + Be a thought leader, build assets and best practices and develop the next level of transformation experts Travel may be required for this role. The amount of travel will vary from 0 to 100% depending on business need and client requirements Here's what you need: + Minimum of 5 years of SAP functional and technical experience/expertise in Quality Management and/or Manufacturing. + Minimum 3 years of experience in SAP projects supporting Chemicals clients. (SAP support / managed services experience will not be considered for this requirement) + Minimum 2 end-to-end SAP S/4 implementations, including project planning, estimation and solution architecture for Chemicals clients + Experience managing SAP delivery teams, in a Global Delivery Model, including but not limited to the following responsibilities: driving complex workshops and leading design decisions, as well as leading the design and execution of system build, configuration, testing, cutover, and go-live in the SAP Transportation Management or Quality Management area + Prior experience in a Consulting and/or Advisory role + Bachelor's degree or equivalent (minimum 12 years' work experience). If Associate's Degree, must have equivalent minimum 6-year work experience Compensation at Accenture varies depending on a wide array of factors, which may include but are not limited to the specific office location, role, skill set, and level of experience. As required by local law, Accenture provides a reasonable range of compensation for roles that may be hired as set forth below. We accept applications on an on-going basis and there is no fixed deadline to apply. Information on benefits is here. (************************************************************ Role Location Annual Salary Range California $94,400 to $293,800 Cleveland $87,400 to $235,000 Colorado $94,400 to $253,800 District of Columbia $100,500 to $270,300 Illinois $87,400 to $253,800 Maryland $94,400 to $253,800 Massachusetts $94,400 to $270,300 Minnesota $94,400 to $253,800 New York/New Jersey $87,400 to $293,800 Washington $100,500 to $270,300 Requesting an Accommodation Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired. If you would like to be considered for employment opportunities with Accenture and have accommodation needs such as for a disability or religious observance, please call us toll free at **************** or send us an email or speak with your recruiter. Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. For details, view a copy of the Accenture Equal Opportunity Statement (******************************************************************************************************************************************** Accenture is an EEO and Affirmative Action Employer of Veterans/Individuals with Disabilities. Accenture is committed to providing veteran employment opportunities to our service men and women. Other Employment Statements Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States. Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Further, at Accenture a criminal conviction history is not an absolute bar to employment. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Additionally, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Company's legal duty to furnish information. California requires additional notifications for applicants and employees. If you are a California resident, live in or plan to work from Los Angeles County upon being hired for this position, please click here for additional important information. Please read Accenture's Recruiting and Hiring Statement for more information on how we process your data during the Recruiting and Hiring process.
    $100.5k-270.3k yearly 20d ago
  • QA Audit Manager

    Incog Biopharma Services

    Quality assurance manager job in Fishers, IN

    Join INCOG Biopharma Services as a Manager of Audits and play a pivotal role in maintaining our reputation as a trusted GMP-certified CDMO. This exciting leadership position offers the opportunity to shape audit strategy, lead regulatory interactions with FDA and EMA, and mentor a dedicated team of audit professionals. You'll be at the forefront of ensuring compliance excellence while working in a collaborative, "All in" culture that values lean thinking and team collaboration. As part of our Quality Systems organization, you'll have direct impact on patient safety and product quality while advancing your career in a growing, innovative company that puts operational excellence at the center of everything we do. This position reports to the Director of Quality Systems and is responsible for leading all audit activities across INCOG's sterile injectable manufacturing operations. The Manager of Audits will oversee internal audit programs, coordinate external regulatory inspections, manage client and supplier audits, and ensure robust audit response and CAPA implementation. This role requires strong leadership skills to manage a small team while maintaining the highest standards of GMP compliance and regulatory readiness in our fast-paced CDMO environment. Essential Job Functions: Lead Comprehensive Audit Program - Manage internal audits, client audits, and regulatory body audits covering all GMP operations, ensuring compliance with FDA, EMA, ICH, and client requirements Lead client audits of INCOG, including coordinating the responses to the client, working with internal teams as well as internal and client QA teams to resolve observations and implement actions and records in response Manage External Regulatory Interactions - Serve as primary point of contact for FDA, EMA, and other health authority inspections, coordinating pre-inspection preparation, leading audit response activities, and managing post-inspection CAPA implementation and regulatory communications Manage internal inspection program, including executing audits, audit reports, and overseeing responses Implement improvements to the system to improve compliance and efficiency of the audit team's operations Direct Team Operations and Development - Manage and mentor 2-3 audit professionals, providing training, performance management, and career development while ensuring adequate resource allocation and team readiness for all audit activities Ensure Documentation and Reporting Excellence - Prepare comprehensive audit reports with risk assessments and corrective action recommendations, maintain GMP-compliant audit documentation, and provide regular management reporting on audit program metrics and compliance status Special Job Requirements: Bachelor's degree in Life Sciences, Engineering, or related field with thorough knowledge of FDA, EMA, ICH regulations and GMP principles for sterile manufacturing operations Minimum 7-10 years pharmaceutical/biotechnology industry experience with focus on quality assurance and auditing, including minimum 3-5 years supervisory or management experience Direct FDA and/or EMA inspection experience and knowledge of international regulatory requirements, computerized systems validation, and data integrity standards Demonstrated experience with regulatory inspections, audit methodologies, risk assessment, CAPA systems, and quality management systems in pharmaceutical manufacturing environment Strong leadership and communication skills with ability to interact professionally with regulatory authorities, clients, and internal stakeholders while managing multiple priorities under pressure Additional Preferences: Advanced degree (MS, PhD) in relevant scientific discipline with professional certifications such as Certified Quality Auditor (CQA) Lean Six Sigma certification or similar process improvement training with experience in validation principles and pharmaceutical manufacturing processes 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.
    $73k-109k yearly est. Auto-Apply 45d ago
  • Quality Assurance Manager

    Bhj Uk Seafood Ltd.

    Quality assurance manager job in Logansport, IN

    BHJ USA, LLC. is a leading supplier of fresh/frozen meat blends to both the wet and dry pet food industries. We are seeking a motivated individual to assure consistent quality of production for plant by developing and enforcing good manufacturing practices (GMP) systems; validating processes, and providing documentation by performing the following duties: • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures• Maintain and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop manufacturing and training methods• Analyze and prepare responses to customer requests, including but not limited to; audits, quality statement and new specifications• Update and maintain HACCP programs and lead scheduled HACCP team meetings• Responsible for calibration and updating of in house analytical testing equipment and communication with equipment vendors regarding technical issues and updates• Responsible for developing and maintaining a Food Safety/Defense Program which complies with USDA/FDA objectives including Food Safety Modernization Act• Complete Certificate of Analysis (COA) forms• In consultation with VP Operations, oversee contact to USDA-APHIS, USDA-FSIS, Nebraska State Department of Agriculture, and FDA• Coordinate group QA initiatives with other QA Managers• In consultation with Plant Manager, responsible for ensuring plant operates in compliance with all laws and regulations• Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations• Adhere to all safety guidelines and wearing of all required safety gear (PPE)• Adhere, support, and enforce all company policies and procedures• Adhere to attendance guidelines of the company at assigned work location H.S. education or GED with at least (1-3) years experience or equivalent education and/or experience. Must also possess the following skills: • Microsoft Office (including Word and Excel)• Bilingual in English/Spanish preferred• Service oriented• Ability to communicate with people across all organizational levels• Ability to work independently and as a part of a team and treat coworkers with respect• Experience in a QA or QC role• Experience in the meat processing industry is desired but not required• Valid driver's license We support a drug free workplace and conduct pre-employment drug screening. Must be authorized to work in the U.S. We participate in E-Verify. EEO Employer. #ZR
    $73k-110k yearly est. Auto-Apply 4d ago
  • Quality Assurance Manager

    Bhj Usa LLC 3.7company rating

    Quality assurance manager job in Logansport, IN

    BHJ USA, LLC. is a leading supplier of fresh/frozen meat blends to both the wet and dry pet food industries. We are seeking a motivated individual to assure consistent quality of production for plant by developing and enforcing good manufacturing practices (GMP) systems; validating processes, and providing documentation by performing the following duties: • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures• Maintain and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop manufacturing and training methods• Analyze and prepare responses to customer requests, including but not limited to; audits, quality statement and new specifications• Update and maintain HACCP programs and lead scheduled HACCP team meetings• Responsible for calibration and updating of in house analytical testing equipment and communication with equipment vendors regarding technical issues and updates• Responsible for developing and maintaining a Food Safety/Defense Program which complies with USDA/FDA objectives including Food Safety Modernization Act• Complete Certificate of Analysis (COA) forms• In consultation with VP Operations, oversee contact to USDA-APHIS, USDA-FSIS, Nebraska State Department of Agriculture, and FDA• Coordinate group QA initiatives with other QA Managers• In consultation with Plant Manager, responsible for ensuring plant operates in compliance with all laws and regulations• Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations• Adhere to all safety guidelines and wearing of all required safety gear (PPE)• Adhere, support, and enforce all company policies and procedures• Adhere to attendance guidelines of the company at assigned work location H.S. education or GED with at least (1-3) years experience or equivalent education and/or experience. Must also possess the following skills: • Microsoft Office (including Word and Excel)• Bilingual in English/Spanish preferred• Service oriented• Ability to communicate with people across all organizational levels• Ability to work independently and as a part of a team and treat coworkers with respect• Experience in a QA or QC role• Experience in the meat processing industry is desired but not required• Valid driver's license We support a drug free workplace and conduct pre-employment drug screening. Must be authorized to work in the U.S. We participate in E-Verify. EEO Employer. #ZR
    $68k-98k yearly est. Auto-Apply 4d ago
  • Quality Control Safety Manager

    Moon Fabricating

    Quality assurance manager job in Kokomo, IN

    Corporation Moon Fabricating Corporation (Moon Tanks) is a leading manufacturer of custom steel tanks, pressure vessels, and industrial linings serving clients across the chemical, power, water treatment, and industrial sectors. For over 60 years, Moon has built a reputation for craftsmanship, safety, and reliability in every project. Position Overview The Quality Control & Safety Manager is responsible for overseeing all aspects of quality assurance, quality control, and workplace safety. This individual ensures that all fabrication, welding, coating, and lining processes meet or exceed customer specifications, regulatory requirements, and company standards. The role combines hands-on inspection with strategic leadership to drive continuous improvement and maintain a culture of safety and quality throughout the facility. Key Responsibilities Quality Control Develop, implement, and maintain the company's Quality Management System (QMS). Inspect in-process and finished tanks, vessels, and linings for compliance with drawings, codes (ASME, API), and customer requirements. Oversee material traceability, weld inspections, and NDE coordination. Maintain all documentation related to quality control, including inspection reports and certifications. Lead root cause analysis and corrective actions for nonconformities. Collaborate with engineering and production teams to identify and prevent quality issues. Safety Management Oversee the company's health and safety programs and OSHA compliance. Conduct regular safety audits, hazard assessments, and toolbox talks. Lead incident investigations and implement corrective actions. Develop and deliver safety training programs for all employees. Ensure proper use of PPE, lockout/tagout, confined space entry, and other safety protocols. Foster a proactive safety culture through leadership and example. Bonus Qualifications Bachelor's degree in Engineering, Industrial Management, or related field (or equivalent experience). 5+ years of experience in quality control and/or safety management in a fabrication, welding, or industrial manufacturing environment. Working knowledge of ASME Section VIII, API, and other relevant codes. Certification(s) preferred: CWI, OSHA 30, or Six Sigma/Lean. Strong analytical, organizational, and communication skills. Proven ability to train, motivate, and influence production teams. Why Join Moon Fabricating Corporation Industry leader with over six decades of excellence. Family-owned culture emphasizing teamwork and safety. Opportunity to make a direct impact on operational quality and employee well-being. Competitive salary, comprehensive benefits, and professional growth potential.
    $68k-105k yearly est. 6d ago
  • Quality of Life Program Manager- Hemophilia- Paragon Healthcare

    Elevance Health

    Quality assurance manager job in Indianapolis, IN

    Be Part of an Extraordinary Team A proud member of the Elevance Health family of companies, Paragon Healthcare brings over 20 years in providing life-saving and life-giving infusible and injectable drug therapies through our specialty pharmacies, our infusion centers, and the home setting. Title: Quality of Life Program Manager- Paragon Ideal candidates will be comfortable traveling 60-70% of the time to local Hemophilia chapters across the U.S. The ability to attend Programs scheduled on nights and weekends will be required. Field: This field-based role enables associates to primarily operate in the field, traveling to client sites or designated locations as their role requires, with occasional office attendance for meetings or training. This approach ensures flexibility, responsiveness to client needs, and direct, hands-on engagement. Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law. Build the Possibilities. Make an Extraordinary Impact. The Quality of Life Program Manager- Paragon is responsible for developing and implementing innovative ""Quality of Life"" (QOL) programs for individuals with bleeding disorders to drive health outcomes and improve therapy adherence. How you will make an impact: Primary duties may include, but are not limited to: * Collaborate with territory representatives to leading the increased business generation and customer retention. * Develops and maintain business relationships with local chapters, clinics, and healthcare providers to enhance the business unit presence and impact in respective territories. * Utilize lifestyle tools and resources within the QOL program to empower patients in managing their health, thus fostering a sense of control over their condition. * Strategically integrate QOL initiatives into sales efforts to shorten the sales cycle and promote seamless health management solutions for patients. * Leverage the QOL program as a significant referral source, contributing to business growth while maintaining cost-effectiveness compared to traditional event sponsorships. * Monitor and evaluate the effectiveness of QOL programs regularly, making data-driven adjustments to ensure optimal patient engagement and satisfaction. * Collaborate with cross-functional teams to align QOL initiatives with overall company objectives and marketing strategies. * Travels to worksite and other locations as necessary. Minimum Requirements: * Requires a BA/BS and a minimum of 5 years of healthcare; or any combination of education and experience which would provide an equivalent background. Preferred Skills, Capabilities and Experiences: * Prior experience as a professional Public Speaker is strongly preferred. For candidates working in person or virtually in the below location(s), the salary* range for this specific position is $71,544 to $112,194 Locations: Colorado, Washington State In addition to your salary, Elevance Health offers benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). The salary offered for this specific position is based on a number of legitimate, non-discriminatory factors set by the Company. The Company is fully committed to ensuring equal pay opportunities for equal work regardless of gender, race, or any other category protected by federal, state, and local pay equity laws. * The salary range is the range Elevance Health in good faith believes is the range of possible compensation for this role at the time of this posting. This range may be modified in the future and actual compensation may vary from posting based on geographic location, work experience, education and/or skill level. Even within the range, the actual compensation will vary depending on the above factors as well as market/business considerations. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law Job Level: Non-Management Exempt Workshift: Job Family: SLS > Sales Operations Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.
    $71.5k-112.2k yearly 9d ago
  • QC/QA Manager

    Heritage Construction + Materials 3.6company rating

    Quality assurance manager job in Indianapolis, IN

    Build your career at Asphalt Materials, Inc! Job Profile Summary The Quality Control (QC) and Quality Assurance (QA) Manager assists the QC QA Director with all aspects of quality management to ensure products and processes meet regulatory requirements, industry standards, and customer expectations. This role focuses on managing the QA/QC teams, provides plant technical support and driving continuous improvement in the quality team. Office will be based in Indianapolis, IN. Job Description: The Quality Control (QC) and Quality Assurance (QA) Manager assists the QC QA Director with all aspects of quality management to ensure products and processes meet regulatory requirements, industry standards, and customer expectations. This role focuses on managing the QA/QC teams, provides plant technical support and driving continuous improvement in the quality team. Office will be based in Indianapolis, IN. Assist in development and implementation of the QA policies, procedures and systems Ensure compliance with applicable regulatory standards (e.g., ISO, FDA, GMP, or other relevant certifications) Oversee quality audits and certifications to maintain compliance with industry and customer requirements Monitor Key Performance Indicators (KPIs) to measure quality performance Supervise QC operations, including testing, inspections, and documentation Ensure that raw materials, in-process products, and final products meet established quality specifications Assist in the development of quality control methods, equipment, and standard operating procedures (SOPs) Investigate and resolve quality issues, including non-conformance reports (NCRs) and corrective action plans (CAPAs) Drive initiatives to improve quality processes, reduce defects, and enhance product reliability Collaborate with cross-functional teams (e.g., operations, R&D, and supply chain) to identify and implement process improvements Stay updated on industry trends and technologies to maintain competitive quality standards Mentor the QA/QC teams, fostering a culture of accountability and excellence Provide training and resources to ensure team members are skilled in quality practices and tools Conduct root cause analyses to address quality issues and implement preventive measures Develop risk management strategies to mitigate quality-related issues Participate in quality-related matters during customer and regulatory audits Additional duties and responsibilities as assigned, including but not limited to continuously growing in alignment with the Company's core values, competencies, and skills. Education Qualifications Bachelor's degree in quality management, chemistry or a related field or 10-15 years equivalent experience is Experience Qualifications 5+ years of experience in quality assurance, quality control, or related fields 3+ years of leadership experience in quality management within manufacturing, pharmaceuticals, or a similar industry Proven track record in managing quality systems, audits, and regulatory compliance Skills and Abilities In-depth knowledge of quality management systems (QMS) and regulatory standards (e.g., ISO 9001, GMP, Six Sigma) Proficiency in quality tools and techniques (e.g., SPC, FMEA, CAPA, root cause analysis) Strong analytical and problem-solving skills with attention to detail Excellent leadership, communication, and interpersonal skills Proficiency in quality management software and tools Strategic thinking to align quality initiatives with organizational goals Commitment to maintaining high standards of quality and safety Strong ability to manage multiple projects and meet deadlines Collaborative approach to working with internal teams and external stakeholders A proactive and hands-on approach to quality management Ability to inspire and lead teams toward continuous improvement and excellence Strong ethical standards and commitment to compliance Dedication to fostering a culture of quality and accountability throughout the organization Ability to travel 30-40%, fluctuates depending upon seasonality of the business Licenses and Certifications Valid driver's license is Working Conditions/Physical Demands Ability to pass a drug test About Asphalt Materials, Inc. Asphalt Materials, Inc. is a privately held, family-owned business headquartered in Indianapolis. Since 1954, Asphalt Materials has prioritized safety and created a people-focused culture around asphalt expertise and innovation. Through its commitment to building long-term relationships with employees, customers and vendors based on trust and confidence, Asphalt Materials creates solutions to issues affecting customers and our communities. Asphalt Materials is a part of The Heritage Group's family of businesses. Learn more at ************************** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #AsphaltMaterialsInc
    $61k-89k yearly est. Auto-Apply 60d ago
  • Quality Assurance Coordinator

    Brightspring Health Services

    Quality assurance manager job in Indianapolis, IN

    Our Company ResCare Community Living The Quality Assurance Coordinator (QAC) position is focused on maintaining local compliance with State, Federal and BrightSpring Health requirements. The QAC provides leadership oversight to operations in meeting operational goals and ensure safety and satisfaction for individuals supported. The QAC will work with local programs within the region to develop, coordinate, implement, and monitor quality assurance initiatives and training programs to ensure the delivery of high-quality supports to the people and organizations we serve. The QAC plays an integral part in ensuring the operations meet regulatory and contractual compliance. The QAC will provide support to directors and administrators within the region. Responsibilities Conducts quality assurance and operational reviews, generate reports, and identify desirable corrective and preventative actions Creates and distributes schedule for quality assurance checks and full audits to ensure audits are completed on a consistent and timely basis Maintains current knowledge of area program regulatory and company requirements to ensure accurate quality assurance review Followscompany procedure and practice for completing various program quality assessment audits Completes Utilization Reviews on a consistent and timely basis Completes follow-up of Quality Assurance audits on a timely basis Requests and attends training to maintain current knowledge of area program regulatory and company requirements to ensure accurate quality assurance review Provides support to the service sites though assistance with quality/compliance regulations Conducts training and assisting with current and new processes Provides direction with regulatory compliance Interprets policy and procedure for operational staff and management Maintains required training per company guidelines and policy Completes other duties as assigned Qualifications HS Diploma/GED; Bachelor's degree preferred A combination of education and homecare experience may be substituted for a degree Experience conducting quality assurance and continuous improvement activities preferred One or more years' experience in quality management Excellent organizational and written skills Ability to maintain positive interpersonal communication with employees and customers About our Line of Business ResCare Community Living, an affiliate of BrightSpring Health Services, has five decades of experience in the disability services field, providing support to individuals who need assistance with daily living due to an intellectual, developmental, or cognitive disability. We provide a comprehensive range of high-quality services, including: community living, adult host homes for adults regardless of disability, behavioral/mental health support, in-home pharmacy solutions, telecare and remote support, supported employment and training programs, and day programs. For more information, please visit ******************************* Follow us on Facebook and LinkedIn. Salary Range USD $21.10 / Hour
    $21.1 hourly Auto-Apply 60d ago

Learn more about quality assurance manager jobs

How much does a quality assurance manager earn in Kokomo, IN?

The average quality assurance manager in Kokomo, IN earns between $60,000 and $132,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.

Average quality assurance manager salary in Kokomo, IN

$89,000
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