Quality System Manager
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
Senior Quality Assurance Specialist
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.
Manual QA
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
Supplier Quality Specialist
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
Quality Control Manager - Life Sciences
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.
Traveling Quality Manager
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
Director of Quality Assurance, RN
Quality assurance manager job in Noblesville, IN
Job Description
Journey is growing, and we are looking for a passionate Director of Quality Assurance (RN) to support and enhance clinical excellence across our facilities. This leader will play a key role in strengthening our quality outcomes, supporting our facility teams, and ensuring we continue to provide exceptional care to the residents we serve.
What You'll Do:
Serve as a clinical resource and support partner to our buildings.
Lead auditing, quality improvement initiatives, and compliance oversight.
Assist with survey readiness, regulatory standards, and follow-up plans.
Coach and mentor clinical leadership teams to elevate performance and resident outcomes.
Monitor key quality and clinical metrics to guide improvement strategies.
Collaborate with senior leadership on best practices and process enhancements.
Ensure alignment with Journey's mission, values, and commitment to resident-centered care.
What We're Looking For:
Registered Nurse (RN) in good standing
Strong background in long-term care, skilled nursing, or clinical operations.
Knowledge of state and federal regulatory standards.
Experience with survey processes and quality assurance/performance improvement (QAPI).
Effective communicator with the ability to coach, support, and guide clinical teams.
Organized, proactive, and driven to make a meaningful impact.
Previous Director of Nursing or MDS experience in long term care.
Why Journey:
At Journey, we believe in supporting our people so they can support others. We value collaboration, growth, and leadership that lifts others up. You will be joining a team that works with purpose, leads with heart, and is genuinely committed to making a difference every day.
If you are a clinical leader who is passionate about improving quality outcomes and empowering teams, we would love to connect.
Quality Assurance Manager I
Quality assurance manager job in Mooresville, IN
The QA Manager I role has a national salary range of $85,000- $150,000. DHL Supply Chain offers multiple benefits including Medical, Dental, Vision, Prescription, Discounted Stock Purchase, General Bonus Plan and a generous PTO policy. Are you looking for a challenging and rewarding opportunity in a fast-paced environment?Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business?Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?
Job Description
Manage and coordinate all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes across a single site / multiple sites and / or single or multiple customers . Confirm requests for quality support from the site and communicate policies and procedures. Expert regarding selected governmental regulations for the site(s). Proactive liaison with customer for quality assurance across site(s). Develop, manage, and oversee site quality resources. Support global and cross-sector Quality and Regulatory initiatives, as required. Support validated processes as applicable for regulated hardware, equipment, and software systems.
* Oversee the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
* Oversee the licenses, permits, and registrations process.
* Manage and provide oversight for regulatory compliance with regards to products handled and services performed at site by assessing performance to cGxP, the contract (OSA, QAA/ TA), and customer requirements as applicable; reporting the results to executive management
* Ensure that systems and equipment are validated (if applicable) and change control processes maintained
* Hire, train, and develop quality associates.
* Monitor the training and development of site associates to ensure compliance to processes and regulations.
* Work in coordination with continuous improvement team to focus/direct continuous improvement activities/workshops
* Review and provide recommendations on regulatory, customer and 3rd party audits.
* Review and identify trends within the quality assurance metrics for the organization.
* Primary customer contact for QA related issues/initiatives as needed.
* Develop, distribute and maintain regular management reports
* Manage site suppliers and prepare, receive, and act on audits
* Provide Business Development support and represent DHL in customer events and meetings as required
Required Education and Experience
* Bachelor Degree or equivalent 4 years work experience, required
* Certification related to quality control, preferred
* 3+ years experience in a regulated environment OR ISO 9001 compliant or certified, required
* 1+ years of supervisory or management experience, required
* Manufacturing, Food, Life Sciences, or 3PL Industry experience, required
* Participation in successful standards organization registration in a complex environment
* Supervising or implementing quality control programs
* Knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
* Administrator of training in compliance to regulated standards
* People development
* People management
* Process development
* Sufficient computer application experience
* Strong written and verbal communication
* Data analysis experience
* Training and facilitation skills
* Self management
* Problem solving
* Project management
* Presenting
* Report creation
* Solution execution
DHL Supply Chain offers multiple benefits including Medical, Dental, Vision, Prescription, Discounted Stock Purchase, General Bonus Plan, 401K and a generous PTO policy.
Our Organization is an equal opportunity employer.#LI-Onse
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Quality Assurance Director
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
Director of Quality Assurance
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.
Director of Quality Assurance
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.
SAP Quality Management/Manufacturing Manager - Chemicals Industry
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.
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QA Audit Manager
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.
Auto-ApplyINCOG BioPharma Services Careers - QA Manager, Batch Review and Disposition
Quality assurance manager job in Fishers, IN
Working closely with the Senior Director of Quality, the Manager will be instrumental in championing and developing our new organization's batch review excellence and a culture of precision, scientific rigor, and timely product release decisions. The Manager will need to successfully lead comprehensive batch reviews, make critical disposition decisions, and ensure compliance with all regulatory requirements.
The Quality Assurance Manager - Batch Review and Disposition will exemplify excellent analytical skills and develop productive, quality-focused working relationships with Manufacturing, Quality Control, , and cross-functional teams. The Manager will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex quality decisions and batch disposition rationales to a range of target audiences. The Manager will thrive in a team environment but will also work autonomously utilizing strong scientific judgment and decision-making skills.
Essential Job Functions:
* Lead comprehensive batch record review processes for sterile injectable drug products, ensuring completeness, accuracy, and compliance with approved manufacturing procedures and specifications.
* Make critical batch disposition decisions (release, reject, or investigate further) based on thorough evaluation of manufacturing data, in-process testing results, and finished product testing.
* Establish and maintain batch review procedures that ensure timely and accurate evaluation of all manufacturing batches while maintaining the highest quality standards.
* Lead investigation of manufacturing deviations and out-of-specification results, determining impact on product quality and appropriate corrective and preventive actions.
* Collaborate with Quality Control to review analytical testing data, certificate of analysis information, and trending of quality attributes across multiple batches.
* Partner with Manufacturing Operations to review batch execution data, process parameters, environmental monitoring results, and equipment performance records.
* Ensure compliance with cGMP requirements and regulatory expectations for batch review and release, maintaining detailed documentation of all disposition decisions.
* Develop and maintain batch review checklists and standard operating procedures to ensure consistent and thorough evaluation processes.
* Lead cross-functional batch review meetings to discuss complex cases, unusual events, and trending of quality data across product lines.
* Maintain batch disposition databases and generate reports on batch release metrics, cycle times, and quality trends for senior management.
* Ensure readiness for regulatory inspections by maintaining comprehensive batch files and being prepared to justify all disposition decisions to regulatory authorities.
* Train and develop team members on batch review processes, quality systems, and regulatory requirements specific to sterile injectable products.
* Utilize electronic batch record systems and quality management systems (Veeva, LIMS, etc.) to ensure data integrity and efficient review processes.
* Apply statistical analysis to identify trends in manufacturing performance and product quality, implementing continuous improvement initiatives.
* Stay current with regulatory guidance on batch review and release requirements from FDA, EMA, and other global regulatory authorities.
Special Job Requirements:
* Bachelor's Degree required; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
* Minimum of 6 years of Quality Assurance experience in pharmaceutical manufacturing with at least 4 years focused on batch review and disposition.
* Expert knowledge of cGMP requirements for batch review, release, and disposition decisions in sterile injectable manufacturing.
* Experience with regulatory inspections and ability to defend batch disposition decisions to regulatory authorities.
* Proficiency with electronic quality systems including LIMS and document management systems.
* Excellent analytical and problem-solving skills with demonstrated ability to make risk-based quality decisions under time pressure.
* Strong project management skills with ability to prioritize multiple batch reviews while meeting customer delivery commitments.
* Exceptional attention to detail and ability to identify potential quality issues that may not be immediately obvious.
Additional Preferences:
* Hands-on experience with aseptic manufacturing Quality.
* Isolator-based aseptic processing experience.
* 3+ years of experience as a people leader or supervisor.
* Experience with building processes and procedures.
* Experience with Continuous improvement, Six Sigma, and/or Lean principles.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyQuality Assurance and Quality Control Manager
Quality assurance manager job in Hagerstown, IN
at Autocar, LLC
Summary: The Quality Assurance and Quality Control Manager is responsible for ensuring the consistent delivery of high-quality products by overseeing and managing both the Quality Control and Quality Assurance functions. This includes enforcing compliance with internal standards, regulatory requirements and customer specifications while driving continuous improvements efforts in the quality process. The QA/EC Manager will lead of team of Quality Engineers, a team of inspectors and quality professionals, support manufacturing processes and collaborate cross-functionally to resolve issues and improve reliability.
Key Responsibilities:
Oversee both the Quality Assurance and Quality Control activities across the manufacturing plant.
Develop, implement, and monitor in process and final product inspection standards and testing procedures.
Ensure compliance with internal quality systems, safety protocols, and regulatory/legal standards.
Investigate product quality issues, perform (RCA) root-cause analysis and lead corrective/preventive actions (CAPA)
Develop quality documentation system including SOP's, inspection plans and QA/QC records.
Collaborate with engineering, operations and supply chain teams to review designs, materials, and manufacturing methods to ensure quality alignment.
Schedule, assign, and supervise QA/EC staff activities while providing coaching and performance evaluations.
Maintain calibration records for test equipment and ensure test equipment is functioning properly.
Create and deliver training on quality standards, testing methods, and continuous improvement technologies.
Report and analyze product quality trends and lead initiatives to reduce defects and scrap rates,
Support audit (internal, customer, third-party) including documentation preparation and follow-up actions.
Liaise with management to manage the QA/QC department budget and resources effectively.
Contribute to team efforts by accomplishing related duties as assigned.
Requirements
Education:
Bachelor's degree in engineering, Industrial Technology, Quality Management, or a related field.
Experience:
5+ years of experience in Quality Assurance and/or Quality Control in a manufacturing environment
Supervisory or team leadership experience required.
Working knowledge of ISO 9001, TS16949, or other quality system standard.
Strong familiarity with tools such as SPC, Six Sigma, FMEA, Root Cause Analysis and CAPA.
Proficient in Microsoft Office Suite and quality management software, familiarity with ERP systems is a plus.
Experience with mechanical inspection tools and equipment (i.e. calipers)
Skills:
Quality system implementation and auditing
Process validation and verification
Strong analytical and problem-solving ability
Excellent verbal and written communication
Leadership and team0buiding skills
Attention to detail and precision
Time management and prioritization
Ability to collaborate across department
Adaptability in a fast-paced environment.
Work Environment:
The primary workspace is in a manufacturing plant environment with occasional office-based responsibilities.
Exposure to loud noise, dust, moving mechanical parts and variable temperatures.
Occasional travel may be required for supplier visitor or quality audits.
Physical Requirements:
Capable of wearing task specific personal protective equipment which may include dust mask, air purifying respirator (i.e., half and/or full faced), safety shoes, gloves, safety glasses, and ear protection.
Capable of meeting OSHA standards for manual lifting guidelines: < 50lbs
While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
Visual acuity to read blueprints and conduct inspection.
Manual dexterity and ability to use measurement and inspection tools.
Ability to stand and/or walk for extended periods.
Ability to work in a variety of weather conditions and temperatures.
Legal and Compliance Statements
At-Will Employment:
This does not create a contract of employment, nor does it alter the at-will employment relationship. Employment with the company is voluntary and may be terminated at will by either the employee or the company, with or without cause, and with or without notice.
Job Duties Disclaimer:
The duties and responsibilities outlined here are representative but not exhaustive of the tasks that the employee may be required to perform. Management reserves the right to modify, add, or remove duties and to assign other tasks as necessary to meet business needs.
Equal Employment Opportunity:
Autocar is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or any other characteristic protected by law.
Compliance with Laws and Policies:
The employee must adhere to all federal, state, and local employment laws and regulations, as well as all company policies and procedures.
Reasonable Accommodations (ADA Compliance):
Autocar complies with the Americans with Disabilities Act (ADA) and provides reasonable accommodations to qualified individuals with disabilities. Employees who require assistance or accommodation should contact Human Resources.
Confidentiality and Data Protection:
Employees are expected to maintain the confidentiality of sensitive information and comply with company policies regarding data protection and proprietary information, in accordance with applicable laws.
Non-Exhaustive List of Duties:
This job description is not intended to be an exhaustive list of all responsibilities or qualifications associated with the position.
Auto-ApplyQuality Manager - Supplier ODA Focal
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.
Auto-ApplyQuality Control Safety Manager
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.
Quality of Life Program Manager- Hemophilia- Paragon Healthcare
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.
QC/QA Manager
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
Auto-ApplyQuality Assurance Coordinator
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
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