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Last updated: 8 hours ago
  • Promoted
QA Operations Specialist

QA Operations Specialist

Novartis Group CompaniesIndianapolis, IN, United States
Full-time
Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Ma...Show moreLast updated: 1 day ago
Sr. QA Representative

Sr. QA Representative

Merck KGaA, Darmstadt, GermanyIndianapolis, United States
Full-time
The primary responsibility for this role is to provide Quality Assurance oversight to manufacturing operations to ensure that production processing and other activities within the manufacturing are...Show moreLast updated: 30+ days ago
  • Promoted
Associate - QA - Manufacturing Logistics

Associate - QA - Manufacturing Logistics

BioSpaceIndianapolis, IN, US
Full-time
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...Show moreLast updated: 12 days ago
QA Engineer - Products

QA Engineer - Products

HCLTechIndiana , USA
Full-time
To develop and deliver codes for the work assigned in accordance with time, quality and cost standards.Show moreLast updated: 30+ days ago
QA Technician

QA Technician

The XCEL GroupIndianapolis, IN
Full-time
To define daily QA tasks, as well as ensuring all raw and finished products meet product specifications.Ensure a clean and sanitary operational room for the processing of fruit and vegetables in ac...Show moreLast updated: 30+ days ago
QA Lead

QA Lead

KobaiIndianapolis, IN, United States
Full-time
San Francisco Bay Area in Pleasanton, CA.We are a fast-growing business analytics company with a rapidly growing customer base and revenue. The company invests in cutting edge data analytics and AI ...Show moreLast updated: 14 days ago
QA Manager

QA Manager

AnaplanIndianapolis, IN, United States
Full-time
At Anaplan, we are a team of innovators who are focused on optimizing business decision-making through our leading scenario planning and analysis platform so our customers can outpace their competi...Show moreLast updated: 14 days ago
  • Promoted
Associate - QA - Manufacturing Logistics

Associate - QA - Manufacturing Logistics

Eli Lilly and CompanyIndianapolis, Indiana, United States
Full-time
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...Show moreLast updated: 15 days ago
Guidewire QA / BA

Guidewire QA / BA

spruceinfotechIndianapolis, IN, United States
Full-time
Company DescriptionJob DescriptionJob Title : Guidewire QA / BALocation : RemoteJob Description : We are looking for a skilled Guidewire QA Engineer to join our team. The ideal candidate will have experie...Show moreLast updated: 14 days ago
PRD QA Engineer

PRD QA Engineer

LillyIndianapolis, Indiana, United States of America
Full-time
We’re looking for people who are determined to make life better for people around the world.Product Research and Development (PRD) Quality Assurance (QA) is responsible for providing quality oversi...Show moreLast updated: 30+ days ago
Specialist QA

Specialist QA

Weil Group, IncIndianapolis, IN, United States
Full-time
SUMMARY Perform one or more of the following duties and responsibilities in support of Client's Quality Assurance program under minimal supervision. FUNCTIONS - Review and approve product MPs.Approv...Show moreLast updated: 14 days ago
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QA Analyst

QA Analyst

VirtualVocationsIndianapolis, Indiana, United States
Full-time
A company is looking for a QA Analyst to ensure the quality and reliability of their software solutions.Key Responsibilities Perform manual testing including functional, regression, smoke, and ac...Show moreLast updated: 8 hours ago
QA Lead

QA Lead

Virtusa CorporationIndianapolis, IN, United States
Full-time
DescriptionSenior Test LeadP1 C2 STSPRIMARY SKILLSBanking domain - PaymentsProven working experience as an Business analystProven working experience as an QA LeadTest ManagementTest Strategy, Test ...Show moreLast updated: 14 days ago
QA / QC Manager

QA / QC Manager

Black & McDonald LimitedIndianapolis, IN, United States
Full-time
ABOUT THIS CAREER OPPORTUNITYBlack & McDonald's Southern Ontario team is growing! If you are committed and collaborative professional looking to contribute to a hard-working, innovative team, this ...Show moreLast updated: 14 days ago
Program QA Manager

Program QA Manager

Bank of MontrealIndianapolis, IN, United States
Part-time
Application Deadline : 05 / 30 / 2025Address : 33 Dundas Street WestJob Family Group : TechnologyThis is an Individual Contributor role (not a people manager) and is subject to Hybrid work model (2 days / week...Show moreLast updated: 14 days ago
QA Batch Release Specialist

QA Batch Release Specialist

NovartisIndianapolis, Indiana, USA
Full-time
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy starting materials manufactured packaged and tested in compliance to current GMP regulations ...Show moreLast updated: 1 day ago
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QA Operations Specialist

QA Operations Specialist

Novartis Group CompaniesIndianapolis, IN, United States
1 day ago
Job type
  • Full-time
Job description

Job Description Summary

Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis Isotopes manufacturing site.

Location : Indianapolis #LI-Onsite

Shift : This position involves shift work which will be defined through site start up and commercialization readiness. This position involves on-call shifts, if required, when scheduled

Job Description

Key Responsibilities :

  • Supports the qualification, validation and operational readiness of the ongoing expansion in Indianapolis Isotopes manufacturing site.
  • As the project progresses, this role will transition to provide shopfloor QA support and oversight of GMP operations during qualification and validation runs, and other related job duties as assigned.
  • Once the site is operational the role accountabilities will transition to :

Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.

  • Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
  • Assist functional areas with achieving timely and compliant final product disposition of the product and ensure compliance of site personnel according to current procedures and GMP requirements
  • Review, approve and support procedures and production / testing records as required and assist in the training of site associates.
  • Support FDA / Regulatory interactions for the Indianapolis Isotopes site activities and Isotopes products to ensure successful regulatory submissions and inspections.
  • Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
  • During the initial project expansion project phase, the role will be in daytime. The role will move to shift work once qualification and validation activities start and during the operational manufacturing once the site is approved
  • Essential Requirements

  • Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree.
  • 2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations
  • 1+ years of experience in a quality assurance role
  • Collaborating across boundaries
  • Functional Breadth
  • QA and / or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones
  • Novartis Compensation and Benefit Summary : The pay range for this position at commencement of employment is expected to be between $81,200 and $150,800 / year; however, while salary ranges are effective from 1 / 1 / 25 through 12 / 31 / 25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and / or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company 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, Company or individual department / team performance, and market factors.

    EEO Statement :

    The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

    Accessibility and reasonable accommodations

    The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

    Salary Range

    81,200.00 - $150,800.00

    Skills Desired

    Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence