Quality assurance manager jobs in Indianapolis, IN - 268 jobs
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Quality Assurance Manager
Quality Assurance Director
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Supplier Quality Manager
Corporate Quality Manager
Quality Assurance Coordinator
Director Of Quality
Quality Systems Manager
Quality Assurance Specialist
Manufacturing Quality Manager
Quality System Manager
Harba Solutions Inc.
Quality assurance manager job in Indianapolis, IN
Key Responsibilities
Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements
Oversee document control, change management, deviation handling, CAPA, and training programs
Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections
Ensure compliance across all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines
Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment
Review and approve investigations, deviations, nonconformances, and customer complaints, including root cause analysis and corrective actions
Maintain quality performance metrics and prepare management review reports to monitor system effectiveness
Partner with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain requirements
Review and approve SOPs, validation protocols, and quality agreements
Ensure all associates receive appropriate quality and compliance training
Support continuous improvement initiatives to drive operational excellence and regulatory compliance
Qualifications
Bachelor's degree in Life Sciences, Quality Management, Engineering, or a related field (advanced degree preferred)
5+ years of quality or compliance experience within pharmaceutical manufacturing
Strong knowledge of cGMP, GDP, FDA, and ICH regulations
Experience managing quality systems, audits, and regulatory inspections
Proven ability to interpret and apply regulatory requirements in a regulated logistics environment
Excellent communication, leadership, and problem-solving skills
Proficiency with QMS software and standard business tools
$67k-109k yearly est. 2d ago
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Director of Quality and Population Health
Medasource 4.2
Quality assurance manager job in Kokomo, IN
Job Title: Director of Quality and Population Health
Client: Healthcare Provider Client
Length: 6-month Contract-to-Hire
Under direction of the Chief Medical Officer and in close partnership with executives, site leaders, and others, the Director of Quality and Population Health (the Director) provides the leadership necessary to assure that the client stays in compliance with HRSA, UDS reporting, Joint Commission accreditation, payer quality programs, and internal clinical standards.
Creates and sustains a high-quality, safe, clinical care enterprise,
Sustains upper quarter performance of the clinical quality measures to which they are held accountable (Uniform Data System (UDS) Clinical Quality Measures, Health Resources and Services Administration (HRSA), Healthcare Effectiveness Data and Information Set (HEDIS) payer quality programs and internal clinical standards, as examples),
Maximizes the client's performance in value-based payment relationships
Positions the client to progressively improve its impact on the Social Determinants/Drivers of Health which influence the outcomes of clients.
The Director demonstrates behaviors consistent with professional standards of practice, care, and the mission, values, and goals of the client.
Essential Duties and Responsibilities
Devises and implements the Quality Improvement Plan in accordance with the client's Mission and goals, state and federal laws and regulations, Health Resources and Services Administration (HRSA) compliance, Joint Commission and other accreditation standards.
Facilitates and leads the Quality Improvement/Quality Assurance (QI/QA) committee.
Administers the Quality Program: structure, committee cadence, and dashboards
Defines quality goals, targets and expected workflows for clinics.
Leadership and direction of members of the Quality Department using Lean, PDSA or Six Sigma tools
Owns corrective action plans after audits, site visits, or adverse events
Oversee the client's QI/QA programs and policies.
Builds and supports development of standardized clinical workflows for chronic disease management, preventive care access and care coordination to assure a reliably high level of efficient clinical care across the entire JPCHC enterprise.
Partners with nursing, providers, and site managers to close care gaps
Standardizes rooming, immunization, lab follow-up, and referral workflows.
Monitors documentation accuracy and supports provider feedback loops
Maintains HRSA FTCA compliance, QA/QI program documentation, and audit readiness
Manages incident reporting, root-cause analyses, and follow-up
Works with compliance to reduce sentinel event risk and standardize practices
Tracks infection control, med-safety, and safety culture metrics
Assists in designing training for quality workflows, documentation standards, and PDSA (Plan-Do-Study-Act)
Coaches site leaders on operationalizing quality initiatives
Ensures protocols meet federal, state and accreditation standards
Identifies and advises organizational leadership on staffing needs to achieve the position's goals.
Identifies and helps to eliminate unbeneficial variations in clinical practice.
Directs processes to establish a culture of event detection, reporting, analysis, resolution, improvement, and learning.
Is a student of continuous improvement and high reliability concepts and works to strengthen organizational capacity and impact with these skills.
Participates and assists with committees, meetings, and team projects related to HRSA policy, Patient Centered Medical Home (PCMH), clinical protocols, and other relevant processes.
Supporting Grant Management: Provides input on and assumes appropriate levels of responsibility for compliance and achievement of grant expectations related to this scope of work.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience
Masters level public health, nursing, or pharmacy training. (i.e. MPH, MSN, DNP, PharmD).
Certified Professional in Healthcare Quality (CPHQ)
preferred
.
Minimum of five (5) years' experience as a supervisor and leader in an ambulatory care setting; primary care
preferred.
Experience and familiarity with Federally Qualified Health Center model of care.
Experience within and knowledge of the Patient-Centered Medical Home initiative
preferred
Knowledge of concepts of disease management, population health management.
Skilled in healthcare population-level data analysis.
Knowledge of pay-for-performance and value-based payment programs. Demonstrated success with leading their achievement
preferred
.
Experience with project management, Six Sigma, lean, or other improvement methodology. Formal certification in lean or six-sigma
preferred
.
Possessing personal attributes of being highly organized, attending to detail, strong follow-up skills, taking initiative, persuasive, and mission-focused with well-developed oral and written communication skills.
Demonstrates sound judgment, decision-making and problem-solving skills.
Exhibits professionalism and confidentiality with all aspects of information in accordance with practice, State and Federal regulations.
Proficient computer skills including with Microsoft Office and electronic health records.
Ability to travel up to 50% of the time to regional practice locations
$90k-114k yearly est. 3d ago
Quality Assurance Manager
Brightpath Associates LLC
Quality assurance manager job in Indianapolis, IN
Job Tittle - Quality Manager
Responsibilities -
Assist Project Teams: Leads Project Teams in developing the Job Specific Quality Plan. Reviews Construction Documents, Specifications, Shop Drawings, and Submittals with the intent to identify challenges and opportunities.
Assist Trade Partners: Leads project Quality pre-installation meetings with Trade Partners. Works with subcontractors to develop and implement Trade Partner Job Specific Quality Plans.
Conduct Quality Site Visits: Reviews and documents work in the field. Photographs and discusses work in place with the project team. Writes reports for each site visit, providing directions and suggestions to correct improper work-in-place.
Assist in Preconstruction: Conducts constructability reviews of future jobs to identify risks and incorporate lessons learned and best practices before construction starts.
Education & Growth: Participates in education and growth opportunities to remain relevant and aware of current trends affecting construction and quality. Attend industry events in the local area and out of town events four to five times a year. Past conferences have included organizations such as Air Barrier Association of America (ABAA), International Institute of Building Enclosure Consultants (IIBEC), World of Concrete, American Contractors Insurance Group (ACIG), Construction Specifiers Institute (CSI), Building Enclosure Science and Technology (BEST), and more.
Expertise: The Quality Engineer will have a general understanding of all elements of construction but will develop focused expertise in building enclosure, concrete, metal stud framing and drywall, flooring, and life safety systems.
Ideal Candidates -
Education: Bachelor's degree in Construction Management, Engineering, Architecture, or related field.
Experience: 3+ years' experience in Construction Management, Design, Construction Technology, or Construction Testing.
Strong background and understanding of Construction Documents and Submittals.
Our team is looking for a candidate with a strong background in Quality Assurance and Quality control in a heavy industry construction environment. This role will be working to support the construction of a brand new pharmaceutical manufacturing plant.
The duration of contract length is 18 months with possible extension.
This role is eligible for PD.
Essential Functions & Responsibilities:
QA/QC Planning & Oversight
Develop and implement site-specific QA/QC plan for logistics, rigging, and equipment connection activities
Oversee inspection and testing to ensure compliance with project drawings, specifications, and industry standards
Compliance & Standards
Ensure all work aligns with procedures, client standards, and applicable codes
Monitor crane and rigging activities for conformance with engineered lift plans
Validate welds, bolted connections, and alignments meet tolerance requirements
Documentation & Reporting
Maintain QA/QC records, inspection reports, nonconformance logs, and corrective action reports
Prepare turnover packages, as-built quality documentation, and close-out records
Provide quality status updates and risk mitigation input to leadership and client representatives
Issue Management & Continuous Improvement
Identify/document nonconformances, coordinate corrective actions, and verify resolutions
Support root cause analysis and ensure lessons learned are captured and communicated
Collaboration
Work closely with Project Managers, Site Supervisors, Safety Managers, and Planners to align QA/QC with execution plans
Attend project meetings and provide expert input on quality issues and risks
Serve as client-facing representative for all quality-related matters
Qualifications:
Minimum 5+ years of QA/QC management experience in industrial construction, rigging, or millwright/ironworker environments
Strong knowledge of steel erection, heavy rigging, crane operations, and equipment setting quality standards
Familiarity with welding and bolting inspection requirements (AWS, AISC, or equivalent)
Proven ability to develop and enforce site-specific QA/QC plans
Strong skills in documentation, reporting, and client-facing communication
Preferred:
Experience in pharmaceutical or advanced manufacturing construction.
Prior engineered heavy lift/logistics QA/QC experience
Certifications such as CWI (Certified Welding Inspector), NDT Level II/III, or other relevant credentials
Familiarity with ISO 9001 or equivalent quality management systems
Other Skills and Abilities Required:
Ability to work in outdoor industrial construction environments
Capable of walking the site, climbing scaffolding/ladders, and overseeing rigging operations in real time
Self-motivated and has a willingness to learn
Familiar with a variety of the field's concepts, practices, and procedures
A wide degree of creativity and latitude is expected
Able to handle high paced work environment
The ability to communicate well with customers and other MATRIX and customer/client employees
Must be dependable.
Must have proficient computer skills.
MATRIX is a proud Service Disabled Veteran Owned Business and an Equal Opportunity Employer.
$72k-109k yearly est. 1d ago
Quality Assurance Compliance Specialist
Aequor Information Technologies Pvt. Ltd. 4.2
Quality assurance manager job in Indianapolis, IN
Job Title : Senior QA Compliance Specialist (Shift hours 8-5)
Duration: 6 months
Purpose
The QA Compliance Specialist implements robust Quality Systems for RLT Indianapolis site considering Novartis and regulatory requirements of the organization. This role contributes significantly to the execution of these systems, authors or contributes to the procedures governing these systems and works towards timely implementation, including experience in Quality Management Review, Self-Inspection, training and in the execution of health authority inspections.
Major Accountabilities
Supports the development and oversight of robust quality systems, including both implementation and operation at site level.
Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.
Works with the management team to implement and execute the Inspection Readiness program; including Novartis Corporate Inspections and Global Health Authority Inspections.
Facilitates training on all 3 programs.
Supports management to implement and maintain the following programs; Training and Qualification, Quality Management Review (KPIs), Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments required to be performed at the site level.
Contributes significantly to the site inspection preparation, program management, response and commitment process.
Escalates high quality risks per procedure and supports agency notifications such as Field Alerts.
Performs duties as assigned to ensure compliance to global and local regulations.
Represent QA Compliance on project teams and in meetings.
Support the continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.
Adheres to all GMP requirements.
Other related duties as assigned.
Required Experiences
8+ years of experience in a GMP Biopharmaceutical environment
2+ years of experience in a Quality Assurance role
Experience reviewing systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues.
Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance.
Previous experience in QA Compliance including self-inspections, preferred.
Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus.
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
Strong follow-up and organizational skills.
Experience with radiopharmaceutical therapies a plus.
Direct experience reviewing and/or authoring standard operating procedures.
Ability to work well independently and within a team.
Excellent oral and written communication skills with technical writing experience required.
Competencies:-
Continuous Learning (Dyn. Knowledge Development)
Digital & Technology Savvy
Operational Excellence
Being Resilient
Breakthrough Analysis
Interpersonal Savvy
Organizational Savvy
Technical / Function Skills & Knowledge As stated above.
Key Performance Indicators (KPIs)
Refer to annual performance target setting.
Education & Qualification:-
B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.
$55k-74k yearly est. 1d ago
Quality Manager
Genuine Search Group
Quality assurance manager job in Indianapolis, IN
Construction Quality Manager
(Quality Manager / Quality Control Manager)
The Construction Quality Manager is responsible for planning, implementing, and overseeing quality control processes to ensure construction work meets contract requirements, design documents, applicable codes, and company standards. This role partners closely with project management, field supervision, subcontractors, and inspectors to proactively prevent defects and drive consistent, high-quality execution across all phases of construction.
Key Responsibilities
Quality Planning & Systems
Develop and manage Project Quality Plans (PQP) or Quality Control Plans
Establish inspection and testing procedures aligned with contract documents
Ensure compliance with project specifications, drawings, and applicable codes
Maintain quality documentation, logs, and records
Field Quality Oversight
Conduct regular jobsite quality inspections and audits
Verify work in place meets approved submittals and specifications
Identify nonconforming work and lead corrective action plans
Coordinate inspections with owners, third-party inspectors, and authorities having jurisdiction (AHJs)
Subcontractor & Trade Partner Management
Review subcontractor quality plans and procedures
Verify trade compliance with installation standards and best practices
Participate in pre-installation meetings and first-in-place inspections
Support subcontractor buyout and onboarding from a quality standpoint
Coordination & Communication
Partner with Project Managers and Superintendents to integrate quality into daily operations
Support constructability reviews and design clarification efforts
Facilitate lessons learned and continuous improvement discussions
Provide clear, timely communication to internal and external stakeholders
Testing, Documentation & Closeout
Track and manage material testing, inspections, and special inspections
Review and maintain quality-related submittals and reports
Support punch list completion and project closeout documentation
Assist with turnover packages and warranty documentation
Continuous Improvement & Training
Promote a culture of “build it right the first time”
Train project teams and trade partners on quality expectations and standards
Identify recurring issues and recommend process improvements
Support company-wide quality initiatives and standardization efforts
Qualifications
Required
Bachelor's degree in Construction Management, Engineering, or related field (or equivalent experience)
5+ years of construction experience with increasing responsibility for quality or field operations
Strong understanding of construction means and methods
Working knowledge of construction codes, standards, and inspection processes
Preferred
Experience in commercial, healthcare, industrial, or institutional construction
Experience with owner, GC, or CM quality programs
Certifications such as:
CQM (USACE)
CQE, CQA, or similar (a plus)
Skills & Competencies
Strong attention to detail and documentation
Ability to lead and influence without direct authority
Excellent communication and conflict-resolution skills
Proactive, solution-oriented mindset
Comfortable working in the field and office environments
Work Environment
Primarily jobsite-based with regular field presence
Collaboration with project teams, owners, inspectors, and trade partners
Travel between project sites may be required
Career Path
Senior Quality Manager
Director of Quality
Operations or Project Leadership roles
$62k-99k yearly est. 1d 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 4.4
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
Supplier Quality Specialist
Stevanato Group
Quality assurance manager job in Fishers, IN
Mission
The Supplier Quality Specialist is responsible for executing activities related to the qualification and certification of suppliers, ensuring their compliance with product and process regulatory requirements, quality standards, and customer expectations. This role supports the achievement of high-quality service delivery by effectively implementing the Quality Management System, contributing to cross-functional processes, and providing expertise in supplier quality management.
Key Responsibilities
1. Supplier Quality Management
Deploy robust, systematic processes for supplier qualification and certification.
Serve as a single point of contact for quality issues related to suppliers.
Collaborate with Supply Chain, Operations, and Commercial teams to provide technical feedback and reports.
2. Supplier Quality Operational Processes
Execute quality specifications for materials, products, and services supplied.
Participate in new product launches and validate supplier capabilities.
Monitor supplier process changes and apply methodologies like PPAP.
Conduct root cause analyses to resolve quality issues.
3. Supplier Qualification Process Management
Develop procedures and questionnaires for supplier qualification and certification.
Support Procurement in supplier selection, assessing process capabilities and risk.
4. Supplier Quality Audit Management
Coordinate and perform supplier audits to evaluate service quality and compliance.
Follow up on audit actions and status of supplier certification.
5. Monitoring and Reporting
Analyze complaint trends, product quality data, and supplier performance.
Propose and implement continuous improvement actions and KPIs.
6. Guideline, Procedures and Document Management
Maintain a supplier repository and related documentation.
Ensure a consistent approach to supplier issues, aligned with QMS standards.
Review and update procedures with cross-functional input.
7. Relationship Management
Act as a liaison with key internal teams and external partners.
Drive awareness and training on supplier quality topics to ensure alignment and compliance.
Skills & Experience
Bachelor's degree in engineering or related field
3-7 max years of experience in a supplier quality role
Excellent written and verbal communication skills
Open to industry
Why should you work with us?
Brand new facility located in the Fishers Life Sciences and Innovation Park
Cafeteria onsite serving breakfast, lunch, and snacks - employees get a daily meal stipend
100% employer paid Dental and Vision benefits
Modern space with brand new technology, climate-controlled production floor
Opportunity for growth, development, and advancement
3 weeks of PTO, 10 paid holidays, 8 sick days
Competitive salary
$44k-71k yearly est. 1d 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 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. 25d 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. 60d+ ago
SAP Quality Management/Manufacturing Manager - Chemicals Industry
Accenture 4.7
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 45d ago
Corporate Quality Manager
Hotrun
Quality assurance manager job in Indianapolis, IN
Are you looking to take your quality career to the next level? Do you have multi-site manufacturing quality experience in a highly regulated environment with expertise in Quality Control, Quality Assurance, and Lean practices?
The successful candidate will lead a plastic flexible packaging quality program across four manufacturing campuses supporting leading food and perishable packaging companies.
Key Responsibilities
Systems Management: Develop, establish, and maintain global quality systems, programs, policies, processes, procedures, and controls. Ensure the performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.
Cultural Leadership: Lead a cultural change within the quality organization from reactive to proactive. Establish strong engagement between quality and operations to achieve the company's quality mission.
Problem Solving: Implement an effective Root Cause and Permanent Corrective Action process to permanently eliminate quality defects and deliver a significant reduction in customer returns and complaints.
Strategy: Develop, implement, and lead an effective quality organizational structure focusing on strategy and driving cultural change within the leadership team.
Decision Making: Make final decisions on administrative or operational issues affecting all quality functions. Participate with the leadership team in developing and establishing company-wide policies.
Operational Excellence: Maintain accountability for the overall effectiveness and operational success of the global quality organization. Successfully integrate these activities with other major organizational segments. Lead, train, and facilitate a company-wide Continuous Improvement process focused on key company objectives.
Requirements
Bachelor's degree is required.
Quality certifications preferred (e.g., ISO, Six Sigma, Lean).
Well-versed in continuous improvement tools and methods with demonstrated proficiency in implementing and facilitating CI teams.
Excellent ability to drive and implement Root Cause and Permanent Corrective Action throughout the organization.
5+ years of quality control/quality assurance experience is required, as well as at least 5 years in a global quality leadership role.
Demonstrated success in developing and leading a company-wide quality function.
Proven success in driving cultural and organizational change that delivers continuous improvement in customer satisfaction.
Ability to bring structure and process to an unstructured environment.
Previous experience with consumer packaging is strongly desired.
Competence in program, metrics, and measures development.
Strong people development and cross-functional collaborative skills.
Ability to manage horizontally and vertically; ability to articulate strategy and results to the executive team while enabling understanding of quality objectives throughout the organization.
Experience with flexible packaging, rigid packaging, and/or printing processes preferred.
If you fulfill these responsibilities, please apply. We offer outstanding compensation, including benefits.
$81k-112k yearly est. 20d ago
Corporate Quality Manager
Hotrun Inc.
Quality assurance manager job in Indianapolis, IN
Job Description
Are you looking to take your quality career to the next level? Do you have multi-site manufacturing quality experience in a highly regulated environment with expertise in Quality Control, Quality Assurance, and Lean practices?
The successful candidate will lead a plastic flexible packaging quality program across four manufacturing campuses supporting leading food and perishable packaging companies.
Key Responsibilities
Systems Management: Develop, establish, and maintain global quality systems, programs, policies, processes, procedures, and controls. Ensure the performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.
Cultural Leadership: Lead a cultural change within the quality organization from reactive to proactive. Establish strong engagement between quality and operations to achieve the company's quality mission.
Problem Solving: Implement an effective Root Cause and Permanent Corrective Action process to permanently eliminate quality defects and deliver a significant reduction in customer returns and complaints.
Strategy: Develop, implement, and lead an effective quality organizational structure focusing on strategy and driving cultural change within the leadership team.
Decision Making: Make final decisions on administrative or operational issues affecting all quality functions. Participate with the leadership team in developing and establishing company-wide policies.
Operational Excellence: Maintain accountability for the overall effectiveness and operational success of the global quality organization. Successfully integrate these activities with other major organizational segments. Lead, train, and facilitate a company-wide Continuous Improvement process focused on key company objectives.
Requirements
Bachelor's degree is required.
Quality certifications preferred (e.g., ISO, Six Sigma, Lean).
Well-versed in continuous improvement tools and methods with demonstrated proficiency in implementing and facilitating CI teams.
Excellent ability to drive and implement Root Cause and Permanent Corrective Action throughout the organization.
5+ years of quality control/quality assurance experience is required, as well as at least 5 years in a global quality leadership role.
Demonstrated success in developing and leading a company-wide quality function.
Proven success in driving cultural and organizational change that delivers continuous improvement in customer satisfaction.
Ability to bring structure and process to an unstructured environment.
Previous experience with consumer packaging is strongly desired.
Competence in program, metrics, and measures development.
Strong people development and cross-functional collaborative skills.
Ability to manage horizontally and vertically; ability to articulate strategy and results to the executive team while enabling understanding of quality objectives throughout the organization.
Experience with flexible packaging, rigid packaging, and/or printing processes preferred.
If you fulfill these responsibilities, please apply. We offer outstanding compensation, including benefits.
$81k-112k yearly est. 22d ago
QC/QA Manager
Heritage Construction + Materials 3.6
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 inIndianapolis, 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 inIndianapolis, 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 required
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 inmanaging 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 required
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 inIndianapolis. 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 - Material/Supplier Management
Eli Lilly and Company 4.6
Quality assurance manager job in Lebanon, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, 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.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered inIndianapolis, 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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. Located in Lebanon, IN, the Lebanon Advanced Therapies (LP2) facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a gene therapy manufacturing site in a highly cross-functional environment. The successful candidate will demonstrate leadership, teamwork, and technical expertise in the onboarding of materials/suppliers required for the Site mission and then provide ongoing oversight for the program.
Position Description:
The MMQA Representative oversees the material/vendor management system for the Lilly Advanced Therapies Site, ensuring compliance with Lilly Quality Standards. They work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers. Responsibilities include program execution/maintenance, improvement, and support for incoming material receipt, batch release, and warehouse operations.
Responsibilities:
Collaborate with site staff and global resources to assist/conduct risk assessments and provide recommendations for Supplier/Service Provider approval
Participate in periodic reviews of supplier performance
Write and coordinate Supplier, Service Provider, and Affiliate Quality Agreements
Represent the voice of quality to material management and supplier certification committees
Provide operational oversight for incoming receipt, sampling, and testing
Perform batch disposition of incoming materials/consumables
Perform SAP data steward functions
Review/redline GMP documents including specifications and procedures
Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee
Support regulatory inspections by providing documentation and SME support
Basic Requirements:
Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience
3+ years working in the pharmaceutical industry in Quality Assurance roles
Additional Preferences:
Previous experience working with and managing suppliers and materials in a regulated environment
Previous experience with SAP or other inventory management systems
Demonstrated knowledge and use of US, EU, Japanese and other regulations in the area of pharmaceutical manufacturing and material/supplier management
Previous facility or area start up experience
Previous experience with deviation and change management systems
Demonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skills
Demonstrated strong problem solving and decision making skills
Previous technical writing experience
Technical aptitude and ability to train and mentor others
Additional Information:
Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office
Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish material management system knowledge
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$65.3k-169.4k yearly Auto-Apply 25d ago
Quality Manager - Supplier ODA Focal
Thyssenkrupp Materials Na 4.4
Quality assurance manager job in Plainfield, IN
Job SummaryDirect, lead and supervise the development of a total quality environment with an emphasis on unexcelled customer satisfaction and continual quality improvement. Accomplish quality-related objectives using quality meetings, planning, training, statistics, and internal/external audits. Ensure that processes and products are in compliance with the current Quality Management System requirements and applicable regulatory obligations. Serve as the designated authority for regulatory programs (e.g., ODA), maintaining compliance with external agency expectations while aligning with company quality standards.Job Description
Key Accountabilities:
•Direct and coordinate all aspects of Quality Management, including ISO/AS/TS compliance, quality improvement initiatives (CQIB), and customer satisfaction strategies to support company goals and objectives.
•Report on the suitability and effectiveness of the Quality Assurance System while fostering a strong quality culture across all branches through leadership collaboration and communication.
•Partner with department managers to establish goals, assess competencies, and guide quality outputs in alignment with corporate Quality Objectives.
•Maintain frequent communication with site Quality Assurance Representatives to ensure consistency, effectiveness, and alignment across regions.
•Lead and oversee quality assurance functions, including planning, statistical process controls, corrective/preventive action systems (CPAR), customer/vendor claims, trend analysis, and documentation of customer quality requirements.
•Direct internal and external audits, provide technical assistance, root cause/corrective action process, manage quality non-conformance and drive employee training and development in quality, regulatory compliance, LEAN, and safety.
•Support overall ODA program activities as required, including maintaining Unit Member records, coordinating application reviews and evaluation panels, tracking required FAA training, and assisting with annual evaluations and related correspondence.
•Assist in developing, revising, and maintaining ODA quality manuals and procedures in collaboration with ODA representatives and stakeholders, ensuring alignment with FAA policies and identifying process or training impacts from regulatory updates.
•Contribute to planning and execution of ODA and FAA audits, including preparing audit materials and reports, coordinating timely closure of corrective actions, and ensuring accurate tracking and reporting of ODA/FAA-required metrics and quarterly submissions.
•Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals.
•Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives.
•Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings.
•Ability to access and work in SAP or other Warehouse Management System
•Provide leadership and direct supervision to quality department teams across multiple functions, ensuring alignment with organizational goals.
•Report directly to the Plant Manager and indirectly to Corporate Regulatory/Trade Compliance leadership to drive corporate quality, standardization, and safety initiatives.
•Participate, support, and comply with all health, safety, quality, ISO and 6S Initiatives, compliance and Lean initiatives, requirements, and/or trainings.
•Ability to access and work in SAP or other Warehouse Management System
The above is intended to describe the general content of and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Meet all other TKMNA employee attributes and competencies
Qualifications:
Minimum Requirements:
This position requires access to export-controlled technical data or technology. Employment is contingent upon obtaining any required export authorization from the appropriate government agency or agencies.
When export authorization is necessary, the length of time to obtain the authorization by the government is outside of the Company's control.
•Bachelor's degree/ 3+ years management experience/ leadership/team building/training in Quality Assurance/Control.
•ODA Certification/industry credential & knowledge of ODA programs, FAA regulations, or aerospace regulatory compliance.
•3+ years relevant experience working as a supplier ODA Focal or Unit Member in an aerospace or any equivalent industry.
•Experience in TQM, ISO/QS 9000 ISO Assessor Certification, SPC.
•Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint, with strong verbal, written, and interpersonal communication skills.
•Demonstrates dedication to delivering high-quality customer service while being positive, detail-oriented, organized, team-oriented, and a proactive problem-solver capable of multitasking and prioritizing in a fast-paced, deadline-driven environment.
Preferred Requirements:
•ASQ certification
•ISO Lead Assessor Certification
•5 years plus Quality Assurance/Control
•3+ years of experience as an FAA ODA Unit Member or Supplier ODA Focal, with working knowledge of FAA rules, regulations, ODA programs, and aerospace regulatory compliance (or equivalent industry experience).
•Training in strategic planning and motivation
Benefits Overview
We offer competitive company benefits to eligible positions, such as :
Medical, Dental, Vision Insurance
Life Insurance and Disability
Voluntary Wellness Programs
401(k) and RRSP programs with Company Match
Paid Vacation and Holidays
Tuition Reimbursement
And more!
Benefits may vary based on job, country, union role, and/or company segment. Please work with your recruiter or tk representative for applicable benefits information.
Disclaimer
This is to notify the general public that some individuals/entities are using the thyssenkrupp (“TK”) name, trademark, domain name, and logo without authorization. They are posing as employees, representatives, or agents of TK and its associated/group companies. These individuals/entities are fraudulently offering jobs online through texts, websites, telephone calls, emails, or by issuing fake offer letters. They are also soliciting jobseekers to deposit money in certain bank accounts or providing jobseekers with fraudulent checks to obtain banking information.
TK does not ask, solicit, or accept any monies in any form from candidates, job applicants, or potential jobseekers, who have applied to or wish to apply to TK, whether online or otherwise as a pre-employment requirement. TK bears no responsibility for money being deposited/withdrawn therefrom in response to such fake offers.
TK does not:
1. Send job offers from free email services like Gmail, Rediffmail, Yahoo mail, etc.;
2. Request payment of any kind from prospective jobseekers or candidates for employment;
3. Authorize anyone to collect money or agree to any monetary arrangement in return for a job at TK;
4. Send checks to job seekers; or
5. Make job offers through third parties. In the event TK uses professional recruitment services through a third party, offers are always made directly by TK and not by any third parties.
PLEASE NOTE:
1. TK strongly recommends that potential jobseekers do not respond to such fake solicitations, in any manner;
2. TK will not be responsible to anyone acting on an employment offer that is not directly made by TK;
3. Anyone making an employment offer in return for money is not authorized by TK; and
4. TK reserves the right to take legal action, including criminal action, against such individuals/entities.
TK follows a formal recruitment process through its own HR department and applications are evaluated by its HR department through pre-defined processes. Please visit our official careers website at ******************************** to view authentic job openings at TK.
If you receive any unauthorized, suspicious, or fraudulent offers or interview calls, please email us at **********************************************.
We shall not accept any liability towards the representation made in any fraudulent communication or its consequences, and such fraudulent communication shall not be treated as any kind of offer or representation by TK or its group companies and affiliates.
$93k-116k yearly est. Auto-Apply 60d+ ago
Quality Assurance Coordinator
Brightspring Health Services
Quality assurance manager job in Indianapolis, IN
Job Description
The Quality Assurance Coordinator (QAC) position is focused on maintaining local compliance with State, Federal and BrightSpring Health requirements. The QAC provides leadership oversight to operations in meeting operational goals and ensure safety and satisfaction for individuals supported. The QAC will work with local programs within the region to develop, coordinate, implement, and monitor quality assurance initiatives and training programs to ensure the delivery of high-quality supports to the people and organizations we serve. The QAC plays an integral part in ensuring the operations meet regulatory and contractual compliance. The QAC will provide support to directors and administrators within the region.
Responsibilities
Conducts quality assurance and operational reviews, generate reports, and identify desirable corrective and preventative actions
Creates and distributes schedule for quality assurance checks and full audits to ensure audits are completed on a consistent and timely basis
Maintains current knowledge of area program regulatory and company requirements to ensure accurate quality assurance review
Followscompany procedure and practice for completing various program quality assessment audits
Completes Utilization Reviews on a consistent and timely basis
Completes follow-up of Quality Assurance audits on a timely basis
Requests and attends training to maintain current knowledge of area program regulatory and company requirements to ensure accurate quality assurance review
Provides support to the service sites though assistance with quality/compliance regulations
Conducts training and assisting with current and new processes
Provides direction with regulatory compliance
Interprets policy and procedure for operational staff and management
Maintains required training per company guidelines and policy
Completes other duties as assigned
Qualifications
HS Diploma/GED; Bachelor's degree preferred
A combination of education and homecare experience may be substituted for a degree
Experience conducting quality assurance and continuous improvement activities preferred
One or more years' experience in quality management
Excellent organizational and written skills
Ability to maintain positive interpersonal communication with employees and customers
$39k-59k yearly est. 25d ago
Warehouse Quality Assurance Coordinator
Geodis Career
Quality assurance manager job in Clayton, IN
Warehouse Coordinator Quality Assurance
Text DELIVER to 88300 to apply or check out more jobs at www.workat GEODIS.com!
GEODIS specializes in unlocking business value in a complex world, ensuring seamless movement of goods worldwide. As a global third-party logistics provider (3PL), we power
A Better Way to Deliver
for the world's top brands and manufacturers. Fuel your career with GEODIS and discover endless growth opportunities.
Look what you'll get by joining the GEODIS team!
Get Good Money - Fair pay and some jobs come with bonus opportunities.
Get the Right Job/Right Schedule - Part-time, full-time, seasonal - days, nights, weekends, and even gig work. We have the job and shift you want.*
Get Paid Early - Pay day as early as you want. Access your earnings on demand.
Get Free Healthcare - Access to telemedicine from day 1 at no cost. Other benefit options include healthcare, dental, vision at affordable costs after a short waiting period.*
Get a Break - Paid holidays, time off, short-term disability and new parent leave are a few of the ways we support time away from work to take care of your life.*
Stay Safe - We pride ourselves on a safe, clean and healthy work environment for everyone.
Get a Voice - We are always asking our teammates to tell us how to make their experience working at GEODIS even better.
Get Promoted - When you are ready to take the next step in your career, we will be there to support you. We promote about 10% of our warehouse workers each year.
Get a Boost - Our GEODIS Compassion Fund makes one-time grants to teammates who have experienced unexpected catastrophes.
Get Involved - Volunteer in your community or donate to the GEODIS Foundation or GEODIS Compassion Fund.
Have Fun - Work with fun, supportive people just like you!
Find Your Place - We value diversity and seek to provide an inclusive culture. Join an Employee Resource Group, participate in an international lunch, or celebrate your heritage to find your place of belonging.
Find Your Future - Whether you are interested in the opportunity to work seasonally or looking to launch your career, GEODIS is the place!
*Eligibility varies based on location, job, employee type, or length of service.
What you will be doing:
Establishes new items in the system to include measurements, SKUs, and pick front locations
Communicates daily with customers by handling all quality issues, holds, releases, special projects and special requests
Performs product function testing to customer standards
Reviews product to ensure it is as described in comparison to our catalogue and/or internet, i.e., without cosmetic defects
Requirements:
High school diploma or GED (General Education Diploma) equivalency
Minimum 1 to 3 years related experience and/or training
Exposure to warehouse management systems
PC literate with experience with Microsoft Outlook, Word and Excel
Ability to apply common sense understanding to carry out instructions
Ability to write reports, business correspondence and procedure manuals required
Must also be able to effectively present information and respond to questions from customers
Ability to define problems, collect data, establish facts and draw valid conclusions
The following statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Job Duties as documented in this job description are considered “Essential Functions” and have been created by the standards of the Equal Employment Opportunity Commission (EEOC). The standards of the Americans with Disabilities Act (1990) require that employees be able to perform “Essential Functions” of the job with or without reasonable accommodation. Reasonable accommodations may be made to enable individuals with disabilities to perform the “Essential Functions”.
More about GEODIS
GEODIS is a global third-party logistics provider powering the supply chains of some of the top brands and manufacturers. Our legacy of excellence in supply chain solutions spans decades. Come find your future with us as we shape the future of logistics. Visit
www.workat GEODIS.com
to learn more.
How much does a quality assurance manager earn in Indianapolis, IN?
The average quality assurance manager in Indianapolis, IN earns between $60,000 and $131,000 annually. This compares to the national average quality assurance manager range of $70,000 to $140,000.
Average quality assurance manager salary in Indianapolis, IN
$89,000
What are the biggest employers of Quality Assurance Managers in Indianapolis, IN?
The biggest employers of Quality Assurance Managers in Indianapolis, IN are: