Senior Quality Assurance Manager
Quality manager job in Indianapolis, IN
JobResponsibilities
Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485, FDA, and other applicable regulations.
Lead, mentor, and manage a team of quality assurance professionals.
Oversee internal and external audits, including preparation, execution, and corrective action follow-up.
Review and approve quality documentation, including SOPs, batch records, CAPAs, and deviation reports.
Collaborate with R&D, Manufacturing, Regulatory, and Operations teams to ensure product quality from development to commercial release.
Monitor key quality metrics and drive continuous improvement initiatives.
Ensure timely response to customer complaints, non-conformances, and regulatory inspections.
Lead risk management initiatives and support product change controls.
Qualifications
Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.
8+ years of experience in quality assurance, with at least 3 years in a leadership role within the medical device, pharmaceutical, or biotech industry.
In-depth knowledge of FDA, ISO 13485, and other applicable quality regulations.
Strong leadership, coaching, and team development skills.
Excellent analytical, problem-solving, and communication skills.
Proven experience with audits, CAPAs, risk management, and compliance documentation.
Senior Quality Assurance Specialist
Quality 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.
Supplier Quality Specialist
Quality 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
Traveling Quality Manager
Quality 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
Quality Engineer
Quality manager job in Noblesville, IN
Operations Engineer - Pharmaceutical Manufacturing | Noblesville, IN
Day Shift | Mon-Fri
Onsite | Direct Hire | Full Benefits Day 1
We're representing a global manufacturer in the pharmaceutical industry that's experiencing significant growth and facility expansion. This new Operations Engineer role is ideal for someone who thrives at the intersection of manufacturing, quality, and engineering. You'll take ownership of quality events, root cause investigations, and process reliability improvements, ensuring consistent production performance in a regulated environment.
What You'll Do
Lead investigations for deviations, non-conformances, and CAPAs
Manage process and reliability improvement projects to reduce recurring issues
Partner with Quality, Production, and Engineering to drive accountability and compliance
Author and review SOPs, Batch Records, and Change Controls
Support regulatory and internal audits
Analyze production data to identify trends and improvement opportunities
What We're Looking For
Bachelor's degree in Engineering or Life Sciences (advanced degree a plus)
2+ years of experience in pharmaceutical or related manufacturing environment
Strong understanding of cGMP and aseptic or cleanroom operations
Experience with root cause analysis and problem-solving tools (5 Whys, Fishbone, etc.)
Project management and technical documentation skills
Lean/Six Sigma certification or exposure preferred
Hands-on, team-oriented approach in a fast-paced setting
Why You'll Love It Here
Global stability with strong local growth and investment
Mission-driven work with direct impact on patient health
Collaborative, team-focused culture and real advancement potential
Competitive compensation, full benefits Day 1, and generous paid time off
Interested? Let's connect.
This is an excellent opportunity to join a growing pharmaceutical operation and make an immediate impact on production reliability, quality, and overall process excellence.
Quality Control Manager - Life Sciences
Quality 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.
Director, Parenteral Sterility Assurance
Quality manager job in Indianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network.
The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
Responsibilities:
Assess differences in current sterility assurance programs across the sites and drive harmonization
Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network.
Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs.
Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking.
Building, maintaining, and growing capability across the organization in the sterility assurance space
Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability.
Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites.
Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice.
Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing.
Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing.
Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
Basic Qualifications:
BS Degree required.
MS/PhD in a biological science preferred.
10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred.
10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred.
Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
Strong written and oral communication skills
Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance
Demonstrated experience influencing site and network leaders to advance technical agenda projects
Additional Preferences:
Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed.
Support the establishment of a sterility assurance network or hub in global TSMS
Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance
Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space
Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance
Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
Strong capability to influence personnel and management across the organization
Close interaction with quality to enable internal audits that identify risks
Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance.
Additional Information:
Approximately 25% travel
Lilly currently anticipates that the base salary for this position could range from between
$133,500
to
$220,000
and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$133,500 - $246,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyDirector of Quality Assurance, RN
Quality 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.
Manager, Clinical Quality
Quality manager job in Fishers, IN
See Yourself at Telix
The Manager, Clinical Quality will be part of a Telix team responsible for establishing, implementing and maintaining appropriate quality assurance processes and documented procedures to ensure that clinical trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). The Manager, Clinical Quality will be responsible for planning, conducting and reporting audits and assessments of Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs) vendors, clinical investigator sites, laboratories, databases, essential documents, systems, processes and procedures.
This position will be dedicated to providing quality oversight and compliance support to Telix's early and late-stage assets.
Key Accountabilities
Plan, arrange, schedule and conduct audits and assessments to ensure compliance with Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs).
Ensure accurate audit documentation from audits of Clinical Investigator Sites, CROs, supporting laboratories, monitoring organizations and other vendors by writing audit plans, audit agendas and audit reports as well as tracking audit responses and resulting CAPAs.
Drive inspection preparation activities for regulatory authority GCP/GCLP/GVP inspections and guide coordination of inspection responses.
Provide Quality oversight and compliance support for Telix study, program, development and matrix teams by attending meetings, representing Clinical Quality and reviewing essential documents.
Ensure accurate and timely review, investigation and closure of temperature excursions, product complaints and clinical trial related investigations.
Review critical processes and procedures to identify gaps in standards, procedures and technologies that are a risk toclinical trial quality.
Participate in initiatives related to critical quality processes such as risk management, data management, trial management, and investigational product management.
Collaborate with the Clinical Operations team to write, revise, and approve appropriate SOPs, Work Instructions and Forms.
Education and Experience
Bachelor's degree in Life Sciences or related discipline required; Master's degree preferred.
American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six SigmaBlack Belt required.
7+ years of experience in Clinical Quality for Manager level and 9+ years in Clinical Quality for Sr. Manager level leading teams in the biotech/pharmaceutical industry
Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations
Excellent time management skills and the ability to work with a sense of urgency
Strong oral and written communication including the ability to present information clearly and logically
Ability to prioritize and manage multiple projects to meet critical deadlines
Strong attention to detail and problem-solving skills
Works effectively in a team environment
Key Capabilities
Ethical Behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
Collaboration: Work effectively as a part of a team, actively sharing knowledge and expertise to achieve common goals
Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
Auto-ApplyDirector of Quality Assurance
Quality 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.
Quality Assurance Director
Quality 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 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.
Quality Manager - Life Science Division
Quality manager job in Whitestown, IN
Job Description
The Langham Logistics Life Sciences Quality Manager impacts the organization by leading the quality team at our Whiteland, Indiana warehouse and distribution facility and acting as the primary authority for all decisions affecting quality aspects of the operations including processes, policies, work instructions, and implemented practices. The Quality Manager will interface directly with the respective quality counterparts of all clients serviced from the Whiteland, Indiana location. He/She drives the quality culture, establishes policies and procedures, oversees implementation of learning management tools and acts as the liaison for all regulatory agency interactions on behalf of Langham Life Sciences and in compliance with the client quality standards for pharmaceutical distribution operations. The position oversees other Quality personnel and is accountable for all quality measures of performance for the operations.
Oversees Quality Indicators
Drives the development of quality culture, strategy, policy, warehouse team objectives and overall processes affecting Quality Assurance in conjunction with clients.
Interprets and applies applicable GxP regulations/policies to unique and often complex issues.
Manages internal and external, routine and non-routine audits/assessments as well as quality projects related to regulatory inspections and potential non-compliance observations.
In partnership with Operations Management, manages resources, priorities, schedules and/or projects to assure delivery of the operational quality objectives.
Leads all projects, programs or team development activities that have GxP compliance implications.
Contributes to a quality culture environment that optimizes employee productivity and participation and adds value to the client.
Develops warehouse operations team skill sets and knowledge base to ensure ongoing compliance with evolving regulations and expectations for quality performance from the client(s).
Directs the activities of one or more direct reports and/or leads a matrix team or business processes, as required for effective management of the quality program.
Actively engages in risk management activities to identify effective risk management strategies including the escalation of risks and their solutions.
Act as a coach, mentor or trainer to develop a passion for quality in others.
Proactively identifies, communicates, and monitors business/regulatory changes that could impact the quality position of the warehouse operations.
Provides suitable recommendations/mutual solutions that show measurable quality improvement and added value to internal/external customers.
Engages with the business in strategic/operational decisions on behalf of the client(s).
Facilitates Achievement of Operations and Quality Performance Expectations
Provides Langham leadership with updates on quality measures and performance for the overall warehouse and distribution operations in Whiteland.
Prepares and presents account level quality performance to Langham leadership on a quarterly basis.
Acts as new and existing account quality lead on behalf of Langham Logistics with responsibility for providing new clients with in-depth analysis on quality programs and metrics available through Langham Logistics business out of the Whiteland location.
Manage and coordinate quality audits and inspections.
Maintains Customer Expectations
Represents Langham Logistics at customer meetings and quarterly business reviews to provide information and updates on quality performance of the operations.
Continually monitors CQA's and CPP's of the operations and makes recommendations on revised policies and procedures in order to maintain world class quality performance.
Serves as the point of contact for client quality requests including reporting, investigations, training updates, inspections and CAPA's.
Facilitates exceptional response to routine and non-routine client requests for data, fulfilment, reporting, customer service support, problem resolution/investigations, and other operational or quality initiatives.
Manages Performance and Systems Reporting
Reviews performance metrics to ensure operations personnel adhere to company and client standards, policies, procedures, and defined goals.
Reviews and analyzes quality metrics to identify recommendations for operational improvements on a continual basis.
Qualifications:
5-7 years' experience in quality management in logistics or pharmaceutical/medical device manufacturing.
Bachelor's Degree in Biochemistry, Chemistry, Biology, or other STEM field preferred.
Demonstrated teamwork, initiative, and problem-solving skills.
Strong analytical, planning and organizational skills with evidence of attention to details.
Mastery of current Good Manufacturing, Good Distribution, and Good Documentation Practices, as they apply to pharmaceutical distribution operations.
Good Communication and Interpersonal Skills a must. Must be able to work as part of a cross functional, interdisciplinary team in order to achieve goals.
Ability to speak and write English. Spanish fluency will be considered a plus.
Strong leadership characteristics and ability to lead in an operations setting is desired.
Skills required:
Leadership - demonstrated competency leading a team and managing others.
Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
Analytical Skills - ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management.
Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
Regulatory Understanding - broad based knowledge of domestic and general knowledge of international regulations (e.g., U.S. FDA 21 CFR Part 11, 205, 211, EudraLex Vol. 4 cGMP, European Commission GDP Guidelines, USP standards, etc.).
Quality Manager Logistics & Distribution (Quality Management Required)
Quality manager job in Plainfield, IN
Job DescriptionQuality Manager - Logistics & Distribution Plainfield IN | On-site, Day Shift First Call Direct Hire is actively recruiting top candidates for this exciting Quality Manager opportunity in a dynamic logistics and distribution environment.
About the CompanyOur client is a profitable, people-driven logistics and distribution organization known for its strong culture, collaborative leadership team, and commitment to employee growth. The company provides a stable, supportive environment where individuals are empowered to take ownership, drive improvement, and make a measurable impact.
About the RoleWe are seeking a hands-on Quality Manager with proven quality management experience. This role is ideal for a high-performing supervisor or assistant manager ready to step into full management responsibility. You will lead a team focused on process quality, not product defects, and interface directly with both internal operations and customer contacts.
Key Responsibilities
Lead and develop a team of salaried supervisors and hourly associates in a fast-paced, people-driven environment.
Partner with operations to identify, analyze, and correct process errors (e.g., incorrect shipments, missing documentation, or quantity variances).
Gather and interpret data to find root causes and implement long-term process improvements.
Serve as the primary customer contact for quality matters, including updates to VP-level stakeholders.
Maintain and improve quality systems - with freedom to innovate and redesign processes as needed.
Promote a positive, accountable culture emphasizing teamwork, trust, and open communication.
Mentor and train younger supervisors, acting as both a coach and collaborator.
Required Experience & Skills
2+ years of hands-on quality management experience with supervisory or team leadership responsibility.
Proven experience in quality assurance, quality control, or process quality management within logistics, distribution, or manufacturing.
Experience implementing or managing ISO 9001, IATF 16949, APQP, PPAP, FMEA, or SPC processes.
Strong track record of driving corrective and preventive actions, continuous improvement, and process optimization.
Ability to interpret complex data and communicate insights to internal teams and customers.
Strong leadership, mentoring, and conflict-resolution skills.
Bachelor's degree preferred (engineering or business-related helpful but not required).
Why You'll Love This Role
Day shift, Monday-Friday - strong work-life balance.
Opportunity to make a visible impact and shape quality processes.
Supportive leadership that empowers you to take initiative.
Collaborative, team-focused environment with open communication at all levels.
Military-friendly employer with a proven record of supporting service members.
Compensation
Competitive salary aligned with experience and leadership capabilities.
Comprehensive benefits package.
Apply today if you are a hands-on Quality Manager with proven quality management experience and are ready to take the next step in your career.
Quality Manager
Quality manager job in Franklin, IN
Accelerate the possible by joining a winning Amcor team that's transforming the packaging industry and improving lives around the world.
At Amcor, we unpack possibility through our innovative and responsible packaging to provide solutions that benefit our customers, our people and our planet. More than 10,000 consumers worldwide encounter our products every second and rely on us for safe access to food, medicine and other goods. We value their trust by making safety our guiding principle. It's our core value and integral to how we do business.
Beyond this core principle, our shared values and behaviors unite us as we work together to elevate customers, shape lives and protect the future. We champion our customers and help them succeed. We play to win - adapting quickly in an everchanging world - and make smart choices to safeguard our business, our communities and the people we serve for generations to come. And we invest in our world-class team, empowering our colleagues to unpack their potential, because we believe when our people grow, so does our business.
To learn more about playing for Team Amcor, visit ************* | LinkedIn | YouTube
Responsibilities
Lead the development and implementation of the plant's quality vision and strategy.
Establish and monitor quality metrics; drive improvements through CAPA and audit processes.
Serve as the primary contact for customer complaints, audits, qualifications, and site visits.
Maintain and audit quality systems, procedures, and GMP compliance.
Oversee daily QA operations including supervision of QA staff, inspection protocols, and training.
Manage customer specifications and ensure alignment with process capabilities.
Act as the ISO Management Representative for the plant.
Identify and communicate quality risks to plant and corporate leadership.
Collaborate with Purchasing and Corporate Quality on supplier corrective actions.
Champion Lean Six Sigma initiatives and continuous improvement efforts.
Develop and execute the annual Quality Improvement Plan.
Support new product introductions and ensure quality requirements are met.
Ensure compliance with national and international standards and regulations.
Facilitate internal and external audits and ensure timely resolution of findings.
Maintain quality documentation, inspection records, and product release programs.
Lead validation and qualification efforts for key manufacturing processes.
Conduct regular team meetings and one-on-one mentoring sessions.
Build strong relationships with internal teams and external customers.
Qualifications
Bachelor's degree in engineering.
5-10 years of quality management experience in a manufacturing environment, preferably FDA-regulated.
Experience managing both salaried and hourly (non-salaried) individuals is required.
Lean Six Sigma Green or Black Belt certification preferred.
Strong leadership and team development skills.
Proficient in 8D, fishbone, and other root cause analysis
Familiar with ANSI sampling plans.
Excellent communication and presentation abilities.
Experience with ISO standards, CAPA, validation, and change control.
Proficient in Microsoft Office (Excel, Word, Outlook); experience with JDE, Infinity QS, and Minitab preferred.
Fluent in English with strong written and verbal skills.
Detail-oriented with strong organizational and project management capabilities.
Ability to work independently and drive results in a fast-paced environment.
Additional Info
Position Summary
The Quality Manager leads the development and execution of plant-wide quality systems, ensuring compliance with customer requirements, internal standards, and regulatory expectations. This role serves as the voice of the customer within the plant and is responsible for driving continuous improvement in product quality, operational efficiency, and customer satisfaction. The Quality Manager also oversees ISO compliance, CAPA processes, change control, validation activities, and Lean initiatives, while contributing to both short- and long-term strategic planning as a member of the plant's leadership team.
Contact
About Amcor
Amcor is a global leader in packaging solutions for consumer and healthcare products. With industry-leading innovation capabilities, global scale and technical expertise, we help our customers grow and meet the needs of millions of consumers every day. Our teams develop responsible, more sustainable packaging in flexible and rigid formats across multiple materials. Supported by a commitment to safety, ~70,000 colleagues across ~140 countries bring our global capabilities to local customers and provide local access to global brands. Our work is guided by our purpose of elevating customers, shaping lives and protecting the future.
Auto-ApplyQuality Manager - Supplier ODA Focal
Quality 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 of Life Program Manager- Hemophilia- Paragon Healthcare
Quality 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.
Quality Control Safety Manager
Quality 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.
QC/QA Manager
Quality 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-ApplyCoordinator External Quality
Quality manager job in Indianapolis, IN
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
This role provides entry-level support to the Quality department. This role supports the overall quality program and may serve as a liaison between the Quality team and other service lines of Versiti. He/she/they may support other service lines by providing quality input on projects and everyday tasks.
Total Rewards Package
Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Responsibilities
Core Quality Responsibilities * Assists Manager in executing the Quality Plan and ensuring compliance with applicable regulations and standards. * Assists Manager in identifying quality system improvements. * Integrates continuous improvement practices adopted by Versiti into quality systems, education, and improvement activities. * Supports internal/external assessments as assigned. * Prioritize tasks to meet the needs of assigned quality objectives. * May prepares charts, tables, etc. to analyze quality metrics. * Review, analyze, approve, and monitor events logged in event management system.
Specific External Quality Coordinator Responsibilities * Provide support to the supplier quality and contract function(s) with a focus on supplier/ customer/ service development-related projects/initiatives * Support the implementation and maintenance of the Supplier Quality Management process to ensure excellent quality of purchased goods * Initiate and resolve supplier non-conformances including root cause and corrective/preventive actions to hold suppliers accountable to Supplier Corrective Action Request (SCAR) commitments * Initiate and resolve Quality exceptions, root cause investigations, containment/corrective actions, risk-based escalation (as appropriate) * Support continuous improvement initiatives, quality system and procedure adjustments * May perform supplier audits and assess non-conformance / audit findings and participate in closure of supplier actions, as needed * May support the maintenance of the contract management process to ensure a consistent and efficient process for the initiation, negotiation, development, review, execution, documentation, monitoring and modification of contractual agreements * May reviewing incoming material from suppliers, if needed, to determine appropriate disposition
Performs other duties as assigned
Complies with all policies and standards
Qualifications
Education
High School Diploma required
or equivalent required
Associate's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) preferred
Bachelor's Degree (in Clinical Laboratory Science, life sciences, engineering with science minor, scientific discipline, or allied health science discipline) preferred
Experience
1-3 years experience required with H.S. diploma required
1-3 years experience required with associates degree required
Experience in QMS, QA, QC, or Quality Auditing preferably in an environment such as blood banking, pharmaceutical, medical devices, or a hospital, preferred
Knowledge, Skills and Abilities
Ability to read and interpret documents such as Standard Operating Procedures, safety rules, operating and maintenance instructions, and other department manuals required
Must have basic mathematical aptitude such as adding and subtracting two-digit numbers and multiplication and divisions with 10's and 100's to be used for weight measurement, volume, distance, and money. required
Ability to apply judgment to detailed but very structured written or oral instructions and to deal with problems involving concrete variable in standardized work procedures. required
Able to organize work to provide productive workflow needed in component preparation. required
Good knowledge of Quality Systems, Compliance, Supplier Quality etc. areas achieved through prior study, preferred preferred
Applies knowledge of the principles and practices in a recognized professional field requiring academic preparation required
Applies knowledge of standardized rules, procedures, and operations within own area required
Performs actions based on previously established guidelines required
Excellent oral communication skills required
Proficiency in Microsoft Office required
Possess strong attention to detail required
Possess good interpersonal skills required
Licenses and Certifications
ASQ CQA, ASQ CQT preferred
Tools and Technology
Personal Computer (desktop, laptop, tablet) required
General office equipment (computer, printer, fax, copy machine) required
Microsoft Suite (Word, Excel, PowerPoint) required
Not ready to apply? Connect with us for general consideration.
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