Quality assurance lead jobs in Bloomington, IN - 141 jobs
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Quality Assurance Manager
Harba Solutions Inc.
Quality assurance lead job in Indianapolis, IN
The Quality Assurance Manager is responsible for leading quality systems and ensuring compliance with FDA regulations and GMP standards within a pharmaceutical manufacturing environment. This role oversees QA operations, manages a team, and partners closely with manufacturing, validation, and regulatory groups to ensure safe, compliant, and high-quality drug products.
Job Responsibilities
Lead and develop the Quality Assurance team, including coaching, training, and performance management
Oversee GMP quality systems including deviations, CAPAs, change control, complaints, and document control
Review and approve batch records, investigations, SOPs, and quality reports
Ensure compliance with FDA, cGMP, ICH, and internal quality standards
Serve as the primary QA contact during internal audits, FDA inspections, and regulatory audits
Partner with manufacturing, validation, QC, and engineering to resolve quality issues and prevent recurrence
Support product disposition and lot release decisions
Drive continuous improvement initiatives to strengthen compliance and reduce risk
Track and trend quality metrics and present findings to site leadership
Qualifications
Bachelor's degree in a scientific or technical field (Chemistry, Biology, Engineering, or similar)
5-8+ years of Quality Assurance experience in a pharmaceutical or GMP-regulated environment
2+ years of people management or leadership experience
Strong working knowledge of FDA regulations (21 CFR Parts 210/211)
Experience leading or supporting FDA inspections
Strong investigation, root cause analysis, and CAPA experience
Excellent written and verbal communication skills
Preferred Qualifications
Experience with sterile manufacturing, aseptic processing, or biologics
Familiarity with validation, data integrity, and quality risk management (ICH Q9)
Experience with electronic QMS and document management systems
Lean Six Sigma or continuous improvement certification
$72k-109k yearly est. 3d ago
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Quality Assurance Automation Engineer
T2 Systems 4.2
Quality assurance lead job in Indianapolis, IN
The QA Automation Engineer ensures the quality and reliability of software products. You will develop and maintain automated test scripts, performance tests, and other test types to validate product functionality and stability. Strong analytical skills, attention to detail, and effective communication are essential for success in this role. You play a critical role in delivering high-quality software that meets customer expectations and contributes to the success of T2 Systems.
Essential Position Functions
Provide QA input and perspective throughout the entire product development lifecycle, following the principle of "shift left"
Advocate for clear requirements and collaborate with the product team to ensure requirements are met and QA processes are followed
Actively contribute to test automation, following and improving automation best practices
Estimate complex QA tasks and deliver high-quality results
Identify and perform non-functional testing, including load and stress testing
Deliver testing and automation on time, resolve blockers, and communicate issues before escalation
Execute tests and automation according to provided estimates and scope
Create feature test plans, test summary reports, deployment plans, and other documentation aligned with the defined QA strategy
Promote test automation to reduce manual testing efforts
Identify and resolve root causes of failed automation tests
Follow defect management procedures
Plan and execute regression testing for product releases to ensure high-quality software delivery
Share knowledge and best practices within the QA department
Identify and communicate cross-product dependencies, collaborating with teams to address them
Contribute to continuous improvement initiatives within teams, the department, and the organization
Education and Qualifications
Bachelor's degree in Engineering, Computer Science, or equivalent experience
3+ years of experience in QA or Software Engineering
3+ years of experience in automated QA testing
Preferred: ISTQB/ASTQB CTFL certification or more advanced
Required Technical Skills
Senior-level knowledge of ISTQB fundamental testing processes, principles, and techniques
Knowledge of non-functional testing theory and best practices (e.g., volume, load, stress, endurance testing, basic OWASP security testing)
Proficiency in QA automation and scripting languages (Python, pytest, and Playwright experience preferred)
Excellent knowledge of automation best practices (e.g., clean coding, Page Object Model, Test Automation Pyramid)
Knowledge of software testing tools and best practices (e.g., SQL, REST & SOAP APIs, mobile testing, Browser Dev tools, CI/CD tools)
Knowledge, Skills, and Abilities
Strong communication skills and work ethic
Skill in problem-solving, risk identification, analysis, and mitigation
Ability to analyze, plan, and estimate QA tasks and deliverables
Familiarity with Agile practices and processes
This position is open to Indianapolis, Indiana, Mesa, AZ and Burnaby, Canada office.
T2 Systems is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
$60k-78k yearly est. 2d ago
Quality Analyst - 3rd shift
Simtra Biopharma Solutions
Quality assurance lead job in Bloomington, IN
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities inBloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
The role:
The Quality Analyst I Batch Release is a member of the Quality Assurance Team (QA) reporting directly to the Quality Supervisor, Batch Release. He or she is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign-out and sign-in of batch records from the Documentation Center. This role will also be responsible for assisting employees with correction resolution and handling the executed batch record documentation while going through the correction process. This role will also have secondary responsibilities assigned to help manage the workload in the Documentation Centers. These responsibilities could include batch record review, support section review, non-batch related documentation review, controlled form reconciliation and audit trail review. He or she provides customer service to internal customers, as well as communicates effectively with all levels of the organization.
The responsibilities:
Perform final batch record review
Reconcile discrepancies with documentation and/or electronic systems as appropriate.
Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record.
As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types.
Manage the process of sign-out and sign-in of batch records.
Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections.
Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
Qualifications:
Bachelor's degree in a science discipline or bachelor's degree in non-science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience.
Demonstrated understanding of quality assurancein an FDA-regulated environment and aseptic processing operations.
Effective organizational, technical and problem-solving skills
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Physical / Safety Requirements
Must wear appropriate personal protective equipment as applicable
Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required
Position requires sitting for long hours but may involve walking or standing for periods of time.
In return, you'll be eligible for[1]:
Day One Benefits
Medical & Dental Coverage
Flexible Spending Accounts
Life and AD&D Insurance
Supplemental Life Insurance
Spouse Life Insurance
Child Life Insurance
Short and Long-Term Disability Insurance
401(k) Retirement Savings Plan with Company Match
Time Off Program
Paid Holidays
Paid Time Off
Paid Parental Leave and more
Adoption Reimbursement Program
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Employee Ownership Plan
Additional Benefits
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Onsite Campus Amenities
Workout Facility
Cafeteria
Credit Union
[1] Current benefit offerings are in effect through 12/31/25
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: **********************************
$58k-75k yearly est. Auto-Apply 3d ago
Software Tester
Collabera 4.5
Quality assurance lead job in Columbus, IN
Collabera is the largest minority-owned Information Technology (IT) staffing firm in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 10,000 professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia) and the United Kingdom. We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers.
Not only are we committed to meeting and exceeding our customer's needs, but we are committed to our employees' satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for four consecutive years since 2012. With over forty offices globally and a presence in seven countries, Collabera provides staff augmentation, managed services and direct placement services to Global 2000 Corporations. Collabera is ranked amongst the top 10 IT staffing firms in the U.S., and for the past 24 years we have continued to grow rapidly year after year.
For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit ***************** to learn more about our latest job openings.
Awards and Recognitions
--Staffing Industry Analysts: Best Staffing Firm to Work For (2015, 2014, 2013, 2012)
--Staffing Industry Analysts: Largest U.S. Staffing Firms (2015, 2014, 2013)
--Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US.
Job Description
Job Details:
Location: Columbus, IN
Job Title: Software Tester
Duration: 3+ Months (Strong possibility of getting Permanent)
Responsibilities:
·
Provides support and assistance to technology team serving as a liaison between business and technology to translate application defects into workable solutions.
·
Assists in the preparation of the testing strategy and testing the execution plan.
·
Works on quality assurance for new releases of a service software application that is being developed in house.
·
Creates and maintains test plans.
·
Conducts unit and system testing.
·
Maintains test results documentation.
·
Assists in identifying and implementing defect resolutions.
·
Gathers, analyzes, and documents current practices, workflows, and business needs to identify efficiencies, alternatives, and gaps.
·
Assists with problem analysis.
·
We need bright, detail oriented, quick learner and has good software testing skills.
·
For current release support - quality assurance validation for development of a service support software application.
·
Program follows project methodology so there is continued repetitive testing cycles of small functionality groupings in addition to end to end full system testing.
Additional Information
To know more about this position, please contact:
Ujjwal Mane
************
****************************
$62k-79k yearly est. Easy Apply 4d ago
Engineer, Quality Assurance
Apidel Technologies 4.1
Quality assurance lead job in Plainfield, IN
Job DescriptionDevelops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.
$62k-86k yearly est. 17d ago
Quality Assurance (Automation) Tester
Govcio
Quality assurance lead job in Indianapolis, IN
GovCIO is currently hiring for a **Quality Assurance (Automation) Tester** to do full lifecycle application testing of EEOC Enterprise applications. This position will be remote. **Responsibilities** Designs, develops, and implements testing methods and equipment to ensure that the product will perform to specifications. Plans and arranges the labor, schedules, and equipment required for testing and evaluating the product. Designs test cases for test plans and creates test scenarios in which tests are carried out. Compiles data, defines required changes and reports defects and problems that occurred during the test process. Implements and participates in the walkthrough of the product. Automated testing may be used for leveling based on hiring manager discretion.
+ Consults with the development and/or requirements team to coordinate and test applications.
+ Performs analysis, diagnostics and preliminary evaluations of products. Develop testing procedures.
+ Develops test plans, scripts, scenarios, functional tests, regression tests, and deployment tests.
+ Implements the testing processes and ensures all test activities follow those processes. Produces reports on each test activity and tracks test metrics.
+ Monitors for continual test process improvement through failure analysis, throughput analysis, yield analysis, and report to management periodically.
**Qualifications**
Bachelor's with 5 - 8 years (or commensurate experience)
Required Skills and Experience
+ Solid understanding of **Agile/scrum** software development and release process.
+ Create mature **automated frameworks** for validating end-to-end scenarios for highly integrated system.
+ **Write Java code** to automate the test of business layer or data layer applications.
+ Core Java skills, **write code using Selenium** and Java.
+ **Proficiency with SQL queries** and solid understanding of backend systems.
+ Solid understanding of implementation of Selenium **BDD** **framework** .
+ Excellent understanding of Cucumber BDD framework and various reporting mechanisms.
+ Solid experience with API testing tools like POSTMAN.
+ Design and develop UI automation framework to support complex applications.
+ Expertise with service-oriented architecture and REST APIs.
+ Test system changes to prepare for production deployment.
+ Execute test plans, scenarios, scripts, or procedures.
+ Document software defects and report defects in JIRA.
+ Perform functional, non-functional, System integration and regression testing.
+ Experience with cloud systems like Azure.
+ Proven experience with Version control systems such as GitHub & Git.
+ Maintain and update automation code with new release of the application.
+ Solid understanding of implementation of Selenium BDD framework.
+ Excellent understanding of Cucumber BDD framework and various reporting mechanisms.
+ Solid experience with API testing tools like POSTMAN.
+ Experience with application monitoring systems like DataDog, Splunk etc.
+ Excellent communication skills.
+ Must be a team player.
Clearance Required: Must be able to acquire EEOC Public Trust
**Company Overview**
GovCIO is a team of transformers--people who are passionate about transforming government IT. Every day, we make a positive impact by delivering innovative IT services and solutions that improve how government agencies operate and serve our citizens.
But we can't do it alone. We need great people to help us do great things - for our customers, our culture, and our ability to attract other great people. We are changing the face of government IT and building a workforce that fuels this mission. Are you ready to be a transformer?
**What You Can Expect**
**Interview & Hiring Process**
If you are selected to move forward through the process, here's what you can expect:
+ During the Interview Process
+ Virtual video interview conducted via video with the hiring manager and/or team
+ Camera must be on
+ A valid photo ID must be presented during each interview
+ During the Hiring Process
+ Enhanced Biometrics ID verification screening
+ Background check, to include:
+ Criminal history (past 7 years)
+ Verification of your highest level of education
+ Verification of your employment history (past 7 years), based on information provided in your application
**Employee Perks**
At GovCIO, we consistently hear that meaningful work and a collaborative team environment are two of the top reasons our employees enjoy working here. In addition, our employees have access to a range of perks and benefits to support their personal and professional well-being, beyond the standard company offered health benefits, including:
+ Employee Assistance Program (EAP)
+ Corporate Discounts
+ Learning & Development platform, to include certification preparation content
+ Training, Education and Certification Assistance*
+ Referral Bonus Program
+ Internal Mobility Program
+ Pet Insurance
+ Flexible Work Environment
*Available to full-time employees
Our employees' unique talents and contributions are the driving force behind our success in supporting our customers, which ultimately fuels the success of our company. Join us and be a part of a culture that invests in its people and prioritizes continuous enhancement of the employee experience.
**We are an Equal Opportunity Employer.** All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity or expression, sexual orientation, national origin, disability, or status as a protected veteran. EOE, including disability/vets.
**Posted Pay Range**
The posted pay range, if referenced, reflects the range expected for this position at the commencement of employment, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, education, experience, and internal equity. The total compensation package for this position may also include other compensation elements, to be discussed during the hiring process. If hired, employee will be in an "at-will position" and the GovCIO reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, GovCIO or individual department/team performance, and market factors.
**Posted Salary Range**
USD $100,000.00 - USD $110,000.00 /Yr.
Submit a referral to this job (**********************************************************************************************************************************************
**Location** _US-Remote_
**ID** _2026-7391_
**Category** _Software Engineering Services_
**Position Type** _Full-Time_
$100k-110k yearly 12d ago
Quality Assurance Analyst
Psi Services 4.5
Quality assurance lead job in Indianapolis, IN
**About PSI** We are PSI Services. We power world leading tests. Delivered with trusted science and the very best test taker experience. PSI supports test-takers on their journey to pursuing dreams and gaining certifications that are important to them. They believe that their dreams are worth working for; that their dreams are worth the effort. And we believe that too. This is our core purpose, to empower people to achieve their dreams. We do this by being the best provider of workforce solutions, which foster both technology and science to deliver the best solutions for our test takers.
We are searching for top talent to join our PSI team and help grow our products and services. We have a creative, supportive and inclusive culture where we empower people in their careers to be their authentic self and make the most of their great talent.
At PSI, we are committed to helping people meet their potential and we believe that promoting diversity, equity and inclusion is critical to our success. That's why you'll find these ideals are intrinsic to our company culture and applied throughout the employee lifecycle.
Learn more about what we do at: *************************
**About the Role**
+ The Quality Assurance Analyst is responsible for ensuring quality of technology that PSI provides to its customers. The person in this role works closely with the Software Engineering teams to understand what has been developed. They also work closely with the solutions and product teams to ensure business requirements are being tested. This role is critical to the successful delivery of PSI's services and the quality of its products. This role adds significant value to the operation of PSI's Credentialing business, as this work is crucial for supporting our customers first-hand with a quality service and maintaining our people-focused brand.
+ This is a full-time permanent role, with flexible hours around core office availability Monday to Friday. The role can be performed remotely, working across time zones, with occasional travel required for meetings, events and workshops.
**Role Responsibilities**
+ Responsible for managing and executing end-to-end testing for key technology platforms and be accountable for test projects.
+ Use principles, guidelines, and best practices as defined, and document testing plans.
+ Gather and present testing metrics and testing activities for the projects to key stakeholders.
+ Closely work with product teams to understand requirements and other performance SLAs.
+ Reviewing and analysing feature requirements exit criteria and design test scenarios.
+ Perform various types of testing, including but not limited to the following: Functional, Regression, integration, backend data validation, usability, end to end system testing, API testing, performance/stress testing and ensure bug-free applications go to production.
+ Writing, executing, and managing the manual test cases.
+ Identify, validate, communicate, and track to closure defects and risks to the development team(s) and clearly communicate testing status and QA roadblocks to the QA manager and Product Managers. Interacts closely with members of cross-functional project team including Development, PMs, and Client Services.
+ Provide the UAT support for business users as well as client.
+ Reporting defects accurately and managing to successful resolution via Jira.
+ Maintaining and creating product knowledge documentation.
+ Investigate and attempt to diagnose customer support reported defects.
+ Participate in sprint planning, scrum, and backlog grooming ceremonies.
+ Researching and embrace new techniques and technology to improve testing
+ Strong SQL skills to validate data from multiple sources like Files, XMLs, Databases.
**Knowledge, Skills and Experience Requirements**
+ 3 years' experience in progressively responsible information technology.
+ Proven experience and knowledge of QA methods, standards and processes, e.g. Agile / SDLC.
+ Excellent numerical skills and understanding of data analysis/statistical methods.
+ Familiarity with the software development lifecycle and with automation testing technologies.
+ Experience with version management and ticketing systems, e.g. SVN, Jira.
+ Experience with RDBMS and SQL, ISTQB principles, testing and debugging in multiple browsers/OS, and experience with API testing tools such as Post-Man or Soup UI.
+ Experience with accessibility testing is huge plus.
+ Experience with QA automation tools, test automation frameworks, writing and executing the automation scripts with Selenium WebDriver in JAVA or C# is preferable but not essential.
**Benefits & Culture**
At PSI, our culture is to be transparent and fair. That's why all of our roles have been benchmarked at a competitive rate against the local market they are based in. To be transparent all of our adverts now include the salary so you can see if we align with your expectations when looking for your next role.
In addition to a competitive salary, we offer a comprehensive benefits package and supportive culture when you join us. This includes:
+ 401k/Pension/Retirement Plan - with country specific employer %
+ Enhanced PTO/Annual Leave
+ Medical insurance - country specific
+ Dental, Vision, Life and Short-Term Disability for US
+ Flexible Spending Accounts - for the US
+ Medical Cashback plan covering vision, dental and income protection for UK
+ Employee Assistance Programme
+ Commitment and understanding of work/life balance
+ Dedicated DE&I group that drive core people initiatives
+ A culture of embracing wellness, including regular global initiatives
+ Access to supportive and professional mechanisms to help you plan for your future
+ Volunteer Day and a culture of giving back to our community and industry through volunteering opportunities
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights (**************************** notice from the Department of Labor.
$58k-82k yearly est. 46d ago
Engineer - FUME & CSQ PRD Quality Assurance
Eli Lilly and Company 4.6
Quality assurance lead 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.
Job Summary:
The Engineer - Facility, Utilities, HVAC, and Equipment (FUME) & Computer Systems Quality (CSQ) QA is a hybrid role that is responsible for the Quality oversight of FUME and computer systems regarding system development and lifecycle support for development and clinical supply operations across Product Research and Development (PR&D) to ensure compliance with quality systems and cGMP. This role provides technical guidance and leadership with non-conformance investigations, construction, equipment and computer systems design and validation, change control proposals, procedure revisions, GMP drawings, commissioning and qualification, and maintenance. This position is essential for maintaining GMP compliance and providing support to internal / external audits.
Key Responsibilities:
Contribute Quality expertise from a FUME standpoint to ensure successful execution of capital projects at LTC-N (primarily focused on K360 pilot plant).
Collaborate with PRD CSQ QA representative(s) to effectively manage CSV workload, ensuring timely and comprehensive delivery of all CSQ work at LTC-N
Coach and mentor others in aspects of fundamental Quality Engineering and computer system validation support, including process knowledge, problem solving, project management, and documentation design.
Provide consultation and interpretation of local procedure, Lilly and Global standards, and regulatory expectations.
Review and approve applicable procedures to ensure compliance with Lilly Quality standards and regulatory requirements. Assess potential gaps between local procedures and Lilly and Global standards and facilitate remediation efforts.
Influence and oversee the Commissioning and Qualification (C&Q) and Computer System Validation (CSV) of GMP assets including review and approval of associated Engineering/GMP deliverables.
Influence and oversee GMP drawings including review and approval of GMP drawings
Evaluate potential product quality impact for any GMP-related incident (Change Control and non-conformance), perform initial leveling, and support the investigations to ensure proper RCA and establishment of effective CAPA to prevent recurrence.
Escalate/Notification to Management for departure of critical nature and assure issues are addressed appropriately.
Perform Quality approvals of GMP documents such as Critical Alarm Audits, Utilities Reports, Business Reviews and Periodic Quality Evaluations
Ensure PR&D is audit ready at all times and participate in internal/external inspections.
Basic Requirements:
Bachelor's degree in biochemistry, engineering, pharmacy, or science-related field
At least 5 years' experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.
Previous experience as a FUME or CSV professional
Additional Skills/Preferences:
Strong knowledge of GMP, FUME processes, and Computer System Validation principles.
Become/remain certified on CSV (Computer System Validation)
Excellent communication and documentation skills.
Ability to work collaboratively in a fast-paced environment.
Proficient in influencing complaint/deviation/change authors via both verbal and written feedback
Proven ability to envision and oversee implementation of continuous improvements
Previous QA experience
Additional Information:
On-site, day shift position located in Indianapolis (LTC-N) with expectation of 3 days per week minimum on-site but flexibility given to the days. After hour support may be required depending on business need.
Occasional travel (
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$65.3k-169.4k yearly Auto-Apply 60d+ ago
Test Analyst
Vergence 3.3
Quality assurance lead job in Indianapolis, IN
Pay: $39.48/hour
In this role you will:
Test planning and execution: Develop and execute test plans, scenarios, scripts, and test cases based on business requirements and technical specifications. Perform functional, integration, regression, and performance testing.
Defect management: Identify, document, and report defects and issues to development teams. Work with developers to resolve problems and ensure quality standards are met.
Data validation: Validate data flow between mainframe systems and other interfaces.
Collaboration: Work with Test supervisor, project managers, Product owners, developers, and other stakeholders to ensure timely delivery of quality software.
Documentation: Create and maintain detailed test documentation, including test results and progress reports.
User support: Provide support to end-users during the User Acceptance Testing (UAT) phase.
Job Requirements:
Extensive knowledge of SDLC and testing methodologies.
Good knowledge and experience with Mainframe testing including testing with technologies like?COBOL,?JCL,?and?DB2,?analyzing batch job results, and collaborating with developers to resolve issues.
Good knowledge and experience with API testing tool.
Any Salesforce testing experience is an added advantage.
Experience working in an Agile environment.
Good knowledge of Atlassian's Jira tool.
Good knowledge of qTest.
Experienced in complete defect cycle and defect management process.
Ability to identify and resolve problems or assist in the development of creative solutions, when necessary.
Ability to communicate effectively both orally and in writing.
Ability to work as part of a team and collaborate with colleagues.
Good English, presentable, confident and good people skills.
Proactive, organized and collaborative approach.
Strong problem-solving skills.
$39.5 hourly 52d ago
Pharmaceutical QA Data Analyst
Global Channel Management
Quality assurance lead job in Indianapolis, IN
Pharmaceutical QA Data Analyst needs 5-7 years experience required. Pharmaceutical QA Data Analyst requires: Hybrid 3 days on-site (Monday, Tuesday and Thursday), 2 days home Flexible on start and end time Strong background in pharmaceutical manufacturing and quality processes and/or laboratory/QC functions
Hands on experience with data management, data remediation, and/or data integrity practices.
Pharmaceutical QA Data Analyst duties:
Monitor non-terminal data and edit/create presentations, charts, diagrams, graphics, and technical documentation.
Create risk assessment documentation,
Create knowledge management documentation
Collaborate with internal teams and stakeholders to assist in analyses of data from a variety of IT systems (MES, LIMS, LES, etc).
$62k-80k yearly est. 60d+ ago
Quality Assurance Analyst II
Kinetic Advantage LLC
Quality assurance lead job in Indianapolis, IN
Description:
Kinetic Advantage is a dynamic independent floorplan company led by trusted industry veterans. Our core focus is helping our Independent Dealer partners and team members succeed while providing them with an exceptional and engaging user experience. We are committed to forging strong partnerships through transparent communication and simple, innovative solutions. We provide our partners and team members with the support and tools they need to grow throughout their journey.
This is a hybrid role with in-office days on Mondays and Wednesdays.
This role is not eligible for visa sponsorship, including H-1B or other employment-based visas, now or in the future.
Job Summary:
The purpose of Quality Assurance Analyst II position is to implement test plans, test cases, and defect management in support of software test requirements. Responsible for working with the Product team to translate business requirements and user stories into functional test requirements while working with the software engineering team to compliment the software development lifecycle. A commitment to collaborative problem solving and quality product is essential.
Duties/Responsibilities:
• Translate business requirements and user stories into test plans and test cases
• Document defects and collaborate with the development team on managing test results
• Develop templates and execute test scripts in tandem with development efforts within a given sprint during the development lifecycle
• Perform regression testing as needed for internally developed applications
• Contribute to the design, process, policy, and procedures for software quality analysis, testing, and feedback
• Participate in an agile team, collaborating with software engineers and IT personnel
• Promote a positive, supportive, and innovative culture of software development
Education and Experience:
• 2+ years prior experience performing quality assurance within the software development lifecycle
• Familiarity with testing and defect tracking tools and methods
• Experience with iterative, incremental software development processes
• Previous experience with the agile software development process and ADO is a plus
• Previous experience working with commercial lending and financial data is a plus
Required Skills/Abilities:
• Comprehensive knowledge with respect to the following:
o Validation of cases against Web Services (SOAP, XML, JSON, REST)
o Validation of cases against Web-based front-end (Angular, React, Vue.js, etc.)
o Querying for validation against Relational Databases (SQL Server preferred)
• Ability to write clearly defined and articulate test cases
• Ability to collaborate, validate, and assist in prioritizing requirements for projects and requests
• Ability to properly assess and articulate risk
• Familiar with Postman for integration testing
• Working knowledge of toolsets such as Work Requests Systems (Jira, TFS, or similar) and Distributed Version Control Systems
• Strong problem-solving abilities, interpersonal and communication skills, and facilitation
Physical Requirements:
• Ability to sit at a desk and work on a computer for prolonged periods of time.
• Must be able to communicate clearly.
• Ability to operate computer and office equipment, maintain paper files, move about an office environment.
• Must be able to move objects up to 20 pounds.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA, and other federal, state, and local standards.
This job description reflects essential functions of this position but is subject to change at any time and does not restrict the tasks that may be assigned.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other factors prohibited by law.
Requirements:
$62k-80k yearly est. 6d ago
Quality Assurance Analyst - Journeyman
ASM Research, An Accenture Federal Services Company
Quality assurance lead job in Indianapolis, IN
ASM Research provides services in support of the Military OneSource Program for military members and their families, similar to a commercial Employee Assistance Program (EAP). This program provides a broad array of information, resources, referrals, and counseling to about 4.7 million persons or "participants," which includes military service members, their families, and eligible civilians at locations worldwide. Services are provided through a 24/7 contact center accessible via internet website, toll free telephone, secure real-time text/video chat, email, or postal mail and include non-medical counseling; financial counseling; tax assistance; spouse education and career information; adoption information; child care; Exceptional Family Member Programs (EFMPs); deployment support; disability information; elder care; educational services for adults, children, and youth; relocation services; pet care; health and wellness coaching; housing assistance; legal service referrals; single service member services; lodging; military benefits; relationship support; skill building services for parenting; spouse relocation and transition; peer-to-peer support; and support for everyday issues (e.g., locating a plumber or automobile mechanic).
Quality Assurance Analysts provide QA support to monitor performance for all Military OneSource operations to meet minimum standards in the SLAs and Performance Metrics. In this role they will monitor customer interactions and review/analyze customer feedback to evaluate overall customer experience. Assigns root cause and identifies systemic quality problems. Uses data from call observations to create quality improvement action plans and drive projects working with team and third-party vendors. Accurately compares measurements between team, vendors and client partners. Reports findings from complaints and call monitoring to the client, internal, and vendor teams. Makes recommendations on quality initiatives.
**Job Responsibilities**
+ Conducts audits and reviews using scoring protocols for calls and/or case records using a pre-determined set of criteria, documenting results in a detailed report.
+ Supports data entry and analysis following URAC minimum standards and defined SOPs as specified in the Quality Management Plan.
+ Maintains and provides all records and reports pertaining to QA documentation.
+ QA Analysts adhere to and promote auditing standards, participate in team meetings, training requirements and calibration sessions.
+ Supports analysis of Duty to Warn, Adverse Incidents, and Mandated Reporting in compliance with defined processes and reporting standards
+ Monitors customer interactions for timeliness of answer, active listening, request/issue identification, correct call hold, professionalism, compliance requirements, request/issue resolution, and appropriate closing.
+ Analyzes survey results for improving communication process and providing feedback to the communication owners.
+ Utilizes quality monitoring program to compile and track performance at individual, functional, and program levels.
+ Provides feedback to agents and managers based on observed strengths and improvement opportunities.
+ Analyzes readership, comprehension and application of communicated actions.
+ Serves as a resource and escalation point for all lines of business so that reviews of calls are accurate for technical content and employees are provided with the correct policies, procedures, and/or reference materials.
+ Identifies trends in service and provides that data to the training team to enhance current training.
+ Documents customer/call communications processes and makes recommendations.
+ Implements operational process improvement initiatives on a regular basis, as well as through long-term projects.
+ Provides call quality metrics data to generate and maintain volume forecasts to support management with scheduling and staffing needs.
+ Leads brainstorming sessions to improve call system, communications processes, customer satisfaction, agent processes and agent effectiveness.
+ Completes activities related to deploying communications including but not limited to creating checkpoints based on important points, creating surveys for reader feedback and continuous improvement, and providing recommendations for communications process improvement.
+ Coordinates with client to create content for agent communications.
+ Develops and distributes new agent communications, researching content and obtaining appropriate feedback and reviews as needed.
+ Creates and implements training plans to orient new hires and ensure a smooth transition from learning environment to daily production environment.
+ Identifies agent communication needs and makes recommendations to Call Center management.
**Minimum Qualifications**
+ U.S. citizen and fluent English speaker
+ Possess strong written and verbal communication skills
+ Must submit to and successfully pass a DoD-initiated Tier 2 - Public Trust Background Investigation
+ Bachelor's degree and 5 years of contact center quality assurance experience (additional 4 years of work experience may be considered in lieu of Bachelor's degree)
+ Solid working knowledge of standard computer software (Microsoft Office business suite to include Outlook, Word, Excel, PowerPoint, and Project)
**Other Job Specific Skills**
+ Demonstrated ability to contribute to quality assurance program creation or execution.
+ Experience with call center call monitoring/recording software.
+ Exceptional customer service and problem-solving skills.
+ Ability to explain and present ideas clearly and concisely to diverse audiences, using appropriate language.
+ Excellent analytical skills and strong decision-making abilities.
+ Proven ability to achieve and maintain departmental quality standards.
+ Strong Internet software and Windows operating systems and software skills.
+ Demonstrated ability to train and develop new and existing support agents.
+ Excellent interpersonal, facilitation, and relationship management skills.
+ Demonstrated ability to effectively communicate and interact with interdepartmental staff and across organizational lines.
+ Critical thinker with the ability to solve complex problems; able to apply quality improvement techniques.
+ Great coordination skills across multiple departments of the Customer system.
**Compensation Ranges**
Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The compensation displayed for this role is a general guideline based on these factors and is unique to each role. Monetary compensation is one component of ASM's overall compensation and benefits package for employees.
**EEO Requirements**
It is the policy of ASM that an individual's race, color, religion, sex, disability, age, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies.
All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, disability, or age. All decisions on employment are made to abide by the principle of equal employment.
Physical Requirements
The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job. (For example, "light office duties' or "lifting up to 50 pounds" or "some travel" required.) Reasonable accommodations may be made to enable individuals with qualifying disabilities, who are otherwise qualified, to perform the primary functions.
**Disclaimer**
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
$25.00
EEO Requirements
It is the policy of ASM that an individual's race, color, religion, sex, disability, age, gender identity, veteran status, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies.
All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, veteran status, disability, gender identity, or age. All decisions on employment are made to abide by the principle of equal employment.
The Project Manager is responsible for being an organized, service-orientated individual to manage projects for a variety of Customers. Position is responsible for communicating with a variety of departments, vendors, employees, and customers to ensure projects are completed on time and to budget. Position also will suggest additional services to Customers that will enhance and/or ensure the safety and efficiency of the Customer's operation.
Responsibilities
Complete Power Systems Tech duties including but not limited to:
Inspect, test, troubleshoot, perform start-up and collect data of low, medium and high voltage (to 500kV) electrical systems.
MCC's, Breakers and moderately complex relay calibration and power metering.
Test and calibrate electro-mechanical and solid-state relay.
Low, Medium and High voltage switchgear and circuit breaker testing.
Rotate emergency on-call duty and if called respond to customer emergencies in a timely manner
Total responsibility for awarded jobs includes but is not limited to:
Order material as needed;
Order subcontract services as needed. Use purchase order and subcontract agreement;
Follow up on all deliveries of materials to ensure job stays on schedule.
Meet customers on-site and review and identify their needs as needed.
Schedule jobs with customer.
Generate work orders for technicians.
Prioritize and formulate an appropriate schedule to execute client work.
Generate accurate detailed reports on a timely basis.
Provide technical support to the field service personnel as it relates to testing and troubleshooting of electrical power distribution systems.
Willing to work on or field supervise projects as needed.
Communicate with clients, management and their team for effective problem resolution and transfer of pertinent information.
Accountable for maintaining status of projects and providing the client with this information.
Conduct client communication in a highly customer service-oriented manner and potentially expand the scope of project work as well as negotiate any extra charges associated with work performed.
Help manage the on-going schedule and travel planning to facilitate timely response to customers.
Work may require flexible hours, weekends, holidays and night work. Must be available for out-of-town work.
All work and decisions shall be conducted in strict compliance of all regulatory law.
Observe all safety rules and Best Practices; Follow all company policies and procedures.
Other duties assigned.
Required Experience and Qualifications:
Bachelor's degree in related field or experience equivalency and a minimum of 5 years NETA Testing related experience.
Active NETA III or IV certification preferred.
Ability to read and understand complex blueprints, schematics, parts lists, and additional technical materials for troubleshooting circuit breakers and electrical power equipment.
Experience in a testing environment.
Effectively communicate verbally and in writing with customers and peers.
Dependable and responsible with good judgment and organizational skills.
Good customer service, time management and follow-up skills.
Self-management of assigned projects and job cost accountability to perform work within budgeted cost estimates.
Able to meet deadlines and handle multiple tasks.
Able to work with various people throughout the organization-Customer Focused.
Focus on accuracy and efficiencies.
For positions that utilize a company vehicle, will be required to have a valid driver's license.
Who we are!
RESA Power is a dynamic, people first organization that prides itself on being the employer of choice in its industry! RESA is fortunate to have an extraordinarily talented group of people who take pride in everything they do! RESA Power has locations throughout the United States & Canada. We are a trusted service provider committed to ensuring the safety, performance, and compliance of electrical distribution systems. With a track record of long-term partnerships and excellence in customer experience for nearly a decade!
Our Mission
Ensure reliable and safe mission-critical power across our customers' electrical infrastructure lifecycle.
Our Vision
To be the premier, first-choice, trusted provider in the US and Canada for critical power services and products by delivering the best customer and employee experience in the industry.
Core Cultural Competencies
We do it right
We pride ourselves on our integrity and expertise. We don't cut corners.
You perform job responsibilities safely, efficiently, and thoroughly all day, every day.
You conduct yourself professionally, ethically, and honestly.
You display sound judgment and decision-making skills. You avoid choosing courses of action that assume unreasonable risk to yourself or the Company.
You are on time and preplan time off.
You produce a quality product.
We are customer driven
Our number one concern is our customer and our long-term relationships with them prove our dedication.
You approach job responsibilities with enthusiasm, professionalism, and in a customer focused manner.
You promote goodwill by handling all contacts (example: coworkers, management, vendors, customers, etc.) with respect, courtesy, cooperation, attentiveness and follow instructions from management.
We focus on growth
We are dedicated to growing the company and our employees.
You understand and apply your knowledge of techniques, policy, procedures, equipment, and skills involved in the job.
You seek out new assignments and assume additional duties.
You seek to expand your abilities (certifications, continuing ed, OTJ experience, etc.).
We solve problems
Every day is different, so we need to be innovative, decision makers, flexible and adaptable.
You efficiently and thoroughly complete assignments.
You perform work assignments independently.
You propose new ideas and find better ways of doing things.
We get it done
We are efficient, reliable and no nonsense. We work hard, but we also play hard.
You follow through on commitments in a timely way.
You produce easily understandable and accurate reports that meet customer and/or Company expectations.
You actively listen. You seek advice and help as appropriate.
You can effectively deliver messages to a variety of individuals (RESA employees, vendors, customers, etc.).
We build strong relationships
Our leaders are servant leaders. We provide you with the support of a well-run company, but the connectedness of a family. We collaborate with each other and our customers.
You collaborate to create the best solutions for each other and our customers.
You build strong relationships within the team, across RESA departments and locations and with customers and vendors.
Additional Information:
Job: Full-Time
Location: Indianapolis, IN
Travel: Up to 50% travel.
Compensation: Pay range for this role is $45.00 to $60.00 (depending on skillset, certification, and experience) per hour and eligible for overtime. Daily meal and incidentals per diem available when traveling for overnight work.
Relocation: Relocation assistance available for highly qualified candidates.
Benefits: Full benefits including medical, dental, vision, company paid life insurance, anniversary bonuses, Employee Ownership Plan, matching 401k, and paid time off.
Application Details: The position will stay open until filled - seeking one FTE. Apply via job postings on job boards or from the company website.
Physical Demands: Lifting or moving a maximum of 50lbs on a daily, crawling, climbing, standing for long periods of time, and working in non-ideal conditions. Also responsible for completing computer work.
RESA Power is an equal opportunity employer.
Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.
$45-60 hourly 40d ago
Dont use CORP_Generic_US_JPMC 'enable auto approval for testing'
JPMC
Quality assurance lead job in Indianapolis, IN
Test
$41k-66k yearly est. Auto-Apply 12d ago
Software QA Engineer
Co-Us Ducharme, McMillen & Associates
Quality assurance lead job in Indianapolis, IN
As an employee-owned company, DMA prioritizes employees. Low turnover rates and tenured teams are living proof:
2025 Great Places to Work Certified
Employee stock ownership program eligibility begins on day one of employment (ESOP contribution is targeted at 6% of your annual compensation)
Company paid parental leave
Generous time off package
Multiple benefit plans, eligibility begins on day one of employment
Culturally focused on work/life balance, mental health, and the overall wellness of our employees
This is a hybrid position with an expectation to be in our Fort Wayne, IN office a minimum of two days per week. This position does not qualify for relocation assistance. Must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. This position does not qualify for employment-based sponsorship.
Essential Duties and Responsibilities
• Create, execute, and maintain test cases, test data, and test scripts for manual and automated testing
• Learn DMA's tax, accounting, and business subject matter to create targeted test cases
• Participate in projects following the approved Development and Testing Methodologies
• Maintain and report results using the approved methodology
• Perform Functional, Non-functional, UAT, and Regression testing on projects as needed
• Understand the QA process and participate in continuous improvement
• Consistently strives to improve the way tasks and activities are accomplished meeting quality objectives
• Contribute to the planning and scheduling of testing
• Utilize Jira (issue tracking system) to monitor and report enhancement and defect tickets
• Participate in the generation and accuracy of all QA documents
• Provide oversight to ensure that the project team follows quality best practices and standards
Non-Essential Duties and Responsibilities
• Perform other duties as assigned
Education and Qualifications
• Bachelor's degree in Computer Science, Engineering, or related field
• Minimum of 2 - 5 years of QA, testing web-based applications, or programming experience. Appropriate college curriculum (computer science courses) considered as 1-year experience
• Previous experience with issue tracking software Jira or similar
• Experience with automation tools like Selenium or experience with Java is highly desired
• Experience with Financial or Business Process applications is a plus
• Ability to manage multiple issues simultaneously
• Proficient with software development life-cycle
• Exceptional verbal and written communication skills
• Strong attention to detail
• Excellent listening skills
#LI-Hybrid
#LI-HH1
The Company is an equal employment opportunity employer and is committed to providing equal employment opportunities to its applicants and employees. The Company does not discriminate in employment opportunities or practices on the basis of race, color, religion, gender, national origin, citizenship, age, disability, veteran status, genetic information, or any other category covered by applicable federal, state, or local law. This equal employment opportunity policy applies to all employment policies, procedures, and practices, including but not limited to hiring, promotion, compensation, training, benefits, work assignments, discipline, termination, and all other terms and conditions of employment.
It is DMA's policy to make reasonable accommodations for qualified individuals with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please contact our Human Resources team at *********************** or ************ and choosing selection 6.
$62k-80k yearly est. Auto-Apply 60d+ ago
Quality Assurance Analyst
Vivos Holdings
Quality assurance lead job in Mooresville, IN
Excellence Wanted. About Us.
Nice-Pak is more than just a Nice Place to Work, and we owe it to our amazing team of nice people to ensure we are hiring new team members who can do more than just meet expectations. We aim to hire excellence.
At Nice-Pak, we manufacture products that touch (literally!) a person's every stage of life - from birth through adulthood into retirement - and worldwide! We are a leading manufacturer of wipes for major grocery, discount, drug, big box, and club membership retailers, and we care deeply about our associates and customers. We care about our environment, too, which is why we stand by our commitment to sustainably source the materials that make our wipes work and support sustainable forestry through education and community engagement.
We live by our purpose of
Creating products for a cleaner, healthier world,
and it's important to us that each time we add someone to our Nice-Pak family, we do so with our purpose statement in mind so we can achieve a workforce as special as our customer base.
About the Job.
Why This Job is Important. The Quality Assurance Analyst is a technical position that supports the Quality Assurance Supervisor, the production floor, and the analytical lab, enabling us to make the highest quality of wipes for our customers. This important position supports operations on manufacturing value streams to ensure every run is of the highest quality every day so that our customers' shelves stay full - and so
their
customers can buy the wipes they need for their baby, teenager, significant other or parent (or even their pet!) when they need to. It's a big deal.
Our best Quality Assurance Analysts are masters of juggling many things at once and know manufacturing basics like quality (cGMP) standards, proper documentation (cGDP) standards, and ISO and CFR standards. We also prefer that each Quality Assurance Analyst has experience in a chemistry or biology lab. Secondary education in a science-related field is also preferred but not required.
We expect our QA Analysts to be professional, results and performance-oriented, highly engaged in the business, and be able to drive engagement within their teams.
What You Can Expect. As a QA Analyst, you would be responsible for inspecting products, providing support, and ensuring all associates have what they need, whether documentation, questions answered, or materials released, to ensure your shift produces the top-quality wipes it should. You also would work closely and partner with cross-functional leaders from the Safety, Operations, Maintenance, Compounding, and Warehouse departments.
Priorities are keeping coworkers safe, products correct, and customers happy. Our QA Analysts must always “think safe” and anticipate production needs to eliminate downtime, eliminate Non-conformance, and ensure the right products are produced at the right time with the right quality and cost.
Other day-to-day recurring responsibilities include working with spreadsheets, reports, emails, batch analytical testing, raw material testing and finished good testing. The QA Analyst communicates to leadership through data using various shift reports to detail the successes and challenges the quality team is experiencing. We expect all of our QA Analysts to anticipate challenges and solve problems creatively.
This is what you can count on from us:
We will provide a safe work environment.
Working conditions free from unusual hazards or otherwise significantly unpleasant conditions - It usually smells amazing on the production floor, and there is a chance you could go home smelling better than you did when you arrived at work.
We want you to succeed and will invest in you and your career.
You can count on us to encourage diversity, equity, and an atmosphere of inclusion.
Great benefits; 401(k) match, and vision, medical and dental coverage. We also offer tuition reimbursement, among other benefits.
Excellent pay, based on experience.
The non-negotiable things.
No shortcuts are allowed. We expect you to support our culture of safety and hold others accountable for it, even if it is uncomfortable.
The Nice-Pak adheres to all local, state, and federal laws, and we expect every employee to do so as well.
You will work with and support many people, so you must communicate respectfully, professionally, and purposefully, both in writing and verbally.
You must be able to read and understand basic math principles, solve problems, and be resourceful on a computer, including Microsoft Office.
What our other Quality Team Members are saying about Nice-Pak:
"Nice Pak has been a welcoming environment that values the safety and quality of our employees and our customers."
-David Wilkins, QC Lab Technician since 2022
The Important HR and Legal Stuff
Nice-Pak is an equal-opportunity employer. We hire the most qualified people to join our team and do not tolerate discriminant behavior. We also adhere to ADA standards and review any reasonable accommodations to try to help you do your job in the best way for you when requested. We also conduct various pre-employment screenings.
#LI-KM
Qualifications
What We Expect from You in the Role.
You will always prioritize safety and quality, above all things, and in that order.
You must be a champion of Nice-Pak; we protect our people, products, and customers.
We expect you will always want to learn, grow, and help others improve too. Continuous improvement and development are the name of the game.
A high school education and demonstrated quality and lab experience in a manufacturing environment OR a bachelor's degree in science (or another closely related field).
We need you to be able to follow directions yet often work independently and know when it's the right time to adjust your work style accordingly.
With over 900,000 square feet of combined warehouse and manufacturing space, our QA Analysts must be able to stand and walk for much of the day. On other days, there are Analytical Testing and desk work, which requires sitting for long periods of time. Sometimes, they may need to stretch, bend, squat, climb, or lift up to 50 pounds to complete a task.
$62k-80k yearly est. 8d ago
Penetration Tester
Ninjaone
Quality assurance lead job in Brazil, IN
Description About the Role The Penetration Tester is a key member of NinjaOne's core security team, with visibility across the entire organization, from individual developers to executive leadership. Taking a multi-layered approach to uncovering weaknesses in software, web applications, and client-side components to drive meaningful security improvements. You will directly strengthen the security of the NinjaOne platform by identifying and helping resolve technical, security, and architectural vulnerabilities across our software applications and environments. English Resume Required. What You'll Be Doing
Perform controlled penetration testing of NinjaOne applications, cloud environments, and infrastructure, demonstrating exploitability and documenting risks and remediation steps.
Collaborate with Engineering to validate vulnerabilities, communicate impact, and support secure design and remediation efforts.
Develop custom tools or scripts to support penetration testing, automation, and exploit development.
Monitor and triage bug bounty submissions, confirming valid findings and routing them to the appropriate teams.
Stay current on emerging threats, TTPs, and cybersecurity trends, applying them to evaluate NinjaOne's exposure and guide security initiatives.
Create clear, comprehensive reports and presentations for both technical and executive stakeholders.
Promote security awareness across the organization, contributing to policies, best practices, and ongoing security education.
Other duties as needed
About You
2+ years of hands-on penetration testing experience.
4+ years in a cybersecurity-related role.
Strong understanding of security protocols, cryptography, authentication/authorization, and modern attack techniques.
Security certifications such as OSCP (highly desired) and/or Security+, CISSP, CISM are a plus.
Proficiency with penetration testing tools such as Burp Suite, Caido, and related frameworks.
Ability to develop custom testing tools or scripts (Java, Kotlin, C++, Python, or Go).
Knowledge of security frameworks and methodologies such as OWASP, NIST, or BSIMM, threat modeling like STRIDE or DREAD, and system hardening standards including CIS and CSA.
Solid understanding of Linux and Windows operating systems, enterprise architecture, TCP/IP and UDP networking fundamentals.
Experience testing or exploiting cloud-native applications; understanding cloud security architecture is a plus.
Strong analytical and problem-solving skills with excellent written and verbal communication
About Us NinjaOne automates the hardest parts of IT to deliver visibility, security, and control over all endpoints for more than 30,000 customers. The NinjaOne automated endpoint management platform is proven to increase productivity, reduce security risk, and lower costs for IT teams and managed service providers. NinjaOne is obsessed with customer success and provides free and unlimited onboarding, training, and support. NinjaOne is #1 on G2 in endpoint management, patch management, remote monitoring and management, and mobile device management. What You'll Love Our flexible working hours with home office options enable you to successfully balance your personal life and your job.
Grow personally and together with one of the fastest growing companies globally.
Develop your skills through our renowned training platform.
Receive competitive compensation.
Collaborate with an amazing international workforce. Additional Information
This position is NOT eligible for Visa sponsorship.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, marital status, veteran status, or any other status protected by applicable law. We are committed to providing an inclusive and diverse work environment. #LI-MM1#LI-REMOTE #BI-REMOTE
$40k-65k yearly est. Auto-Apply 16m ago
Quality Assurance Engineer
EHOB 4.0
Quality assurance lead job in Indianapolis, IN
The Quality Assurance Engineer will support the organization towards compliance of Corporate Quality and Environmental policies, provide leadership, expertise, and guidance for all Quality and Regulatory activities, and assist with required quality and technical tasks.
Essential Duties and Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards for medical device manufacturing.
Develop and implement quality management system documents for product design, development, and manufacturing.
Conduct internal and external audits of quality systems to ensure adherence to quality standards.
Coordinate the activities for Quality Management System (QMS) review and present the supporting data and metrics
Review and approve manufacturing process changes impacting product quality, including changes to equipment and software
Participate in risk management activities (FMEA, risk analysis) to identify potential product risks and implement corrective actions.
Manage non-conformances, CAPA (Corrective and Preventive Action) processes, and root cause analysis.
Collaborate on the investigations of customer complaints, ensure timely and accurate closure and issue reports back to affected customers.
Work with cross-functional teams to resolve quality issues, including R&D, manufacturing, and regulatory departments.
Develop and maintain quality documentation, including process validation protocols, technical reports, and device history records.
Monitor and analyze quality data to identify trends and drive continuous improvement initiatives.
Co-lead with R&D and Manufacturing Engineering the product, process and software validation activities (IQ, OQ, PQ) to ensure the product meets the required specifications.
Co-lead with Sourcing the supplier qualification process and conduct regular audits to ensure that supplied components and raw materials meet quality requirements.
Manage SCAR (Supplier Corrective Action Request) process to address and resolve quality issues arising from suppliers.
Provide the tools and training on quality systems and procedures for internal teams.
Ensure proper calibration and maintenance of quality inspection equipment.
Other duties as assigned
Qualifications
Education and/or Experience
Bachelor's degree in engineering (Mechanical, Electrical, Computer, Biomedical, Industrial, or related field) or equivalent experience.
5+ years of experience in quality assurance/quality engineering in a medical device or related industry.
Strong understanding of regulatory requirements, including FDA 21 CFR 820, ISO 13485
Experience with quality management systems, audits, and compliance.
Experience with MasterControl eQMS is a plus.
Proficiency in root cause analysis and corrective action (CAPA) processes.
Strong analytical and problem-solving skills.
Excellent verbal and written communication skills.
Certified Quality Engineer (CQE) or equivalent certification is a plus.
Familiarity with Six Sigma, Lean manufacturing, or other process improvement methodologies is a plus.
Ability to manage multiple projects and work in a fast-paced environment.
Knowledge of statistical process control (SPC) and other quality control tools is a plus.
Proficiency in quality-related software tools (e.g., Minitab, QMS systems) is a plus.
Other Skills
Language skills: Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public group, and/or boards of directors.
Mathematical skills: Ability to work with mathematical concepts.
Reasoning: Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of information.
Computer skills: Knowledge of Microsoft Office Suite
Competencies
Communication:
Effectively communicate to internal and external business partners by sharing expertise to encourage accomplishment of shared business goals.
Teamwork and Collaboration:
Actively support and collaborate with peers and team members to contribute to overall company success.
Knowledge:
Display knowledge of department, applicable products, services and business objectives. Demonstrate a continuous learning mindset through continued professional and personal development.
Accountability:
Follow through with tasks and responsibilities in an appropriate and timely manner.
Work Quality:
Produces results, meets goals, and provides services that meet or exceed EHOB's standards.
Adaptability:
Readily and effectively adapts way of working, thinking and acting in response to changing workplace conditions, targets or goals.
Strategic Thinking:
Demonstrate ability to understand a situation or obstacle from all perspectives.
EHOB Ambassador:
Reflect EHOB's mission, vision and values.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; risk of electrical shock; risk of radiation and vibration. The noise level in the work environment is usually moderate.
EHOB does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status or military service.
$60k-79k yearly est. 21d ago
CORP_Generic_US_JPMC 'enable auto approval for testing'
JPMC
Quality assurance lead job in Indianapolis, IN
Test
$41k-66k yearly est. Auto-Apply 13d ago
Quality Assurance Associate - Drug Product External Manufacturing
Eli Lilly and Company 4.6
Quality assurance lead 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.
Position Overview
Drug Product External Manufacturing (DPEM) Quality Assuranceassures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, Central and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.
The QA Lead for Contractor Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly GQS by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.
The Principal Associate QA may also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.
Key Objectives/Deliverables:
Lead/ provide support to launch new products/ packages/ CMs
Participate on Joint Process Teams
Understand Lily global quality systems and monitor the CM process to ensure it is compliant as applicable and ensure complaint to Regulatory expectations.
Levelling, reviewing, and approving of event investigations and changes.
Work with Lilly support groups and SME's to resolve product related issues
Participate in the creation and revision of standard operating procedures
Participate on Six Sigma Projects to help improve productivity
Provide support on site or remotely during inspections
Author and track compliance to the CM Quality Agreements and CM Quality Plans
Ensure CMs are following Quality Agreement and appropriate quality systems as part of routine operations. Use regular visits, JPTs and other communications to help to assess/monitor performance.
Routinely have face-to-face communications with CMs
Track and monitor Quality metrics for trends at the CM
Support Qualifications/ Validation document creation and reviews
Provide and coordinate designated sections for Annual Reports and Annual Product Reviews
Execute SOP assessments of CMs and track completion of outstanding issues
Support CMs effort to maintain and improve their quality systems
Provide technical leadership and project management oversight to drive improvements to CM quality systems
Build and maintain regular communication with External Manufacturers and awareness of issues/progress including reporting back to DPEM Management. Also responds to request of information and data.
Benchmark with other Lilly sites to share best practices and drive improvements to CM oversight
Network with external partners and resources to share and learn best practices and trends within the industry
Support batch release activities by determining final disposition of batches by reviewing all required documentation including but not limited to change controls and deviations.
Basic Qualifications:
Bachelor´s Degree in Pharmacy, Chemistry, Biological Science or other relevant field
5+ year of parenteral product manufacturing and quality experience
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/ Preferences:
Knowledge of Pharmaceutical Manufacturing Operations
Strong written and communication skills, especially attention to detail in written procedures and protocol development.
High learning agility.
Strong leadership, interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
Ability to organize, prioritize, multi-task and influence others.
Strong decision making and problem-solving skills.
Willingness to learn new technologies.
Capability to work in a virtual and complex environment.
Proven ability to work independently or as part of a Team to problem solve
Regulatory related experience.
Established technical, quality, and internal networks.
Experience with Lilly systems (SAP, Trackwise, Q docs…etc.).
Preferable minimum of 5 years of experience supporting manufacturing
Additional Information:
Shift is days, but off-hours may be necessary to support operations
Travel up to 30%
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
How much does a quality assurance lead earn in Bloomington, IN?
The average quality assurance lead in Bloomington, IN earns between $61,000 and $104,000 annually. This compares to the national average quality assurance lead range of $72,000 to $123,000.
Average quality assurance lead salary in Bloomington, IN