39 Quality Assurance And Engineering jobs in Indianapolis.

Hiring now: Document Control Supervis @ Incog Biop, Equipment Spec 2Nd Shift @ Incog Biop, Biz Systems Configuration @ Iqvia, Lead Automation Engr @ Cognizant, Cqv Eng Consultant @ Precision , Consultant @ Project Fa, Regulatory Affairs Jobs @ Parexel, Quality Associate @ Azenta Lif, Quality Assurance Positio @ Genezen, Healthcare Quality Adviso @ Federal Ex.Explore more at jobswithgpt.com.

🔥 Skills

GMP (10) Quality Assurance (9) SOPs (6) Compliance (6) manufacturing (5) cGMP (5) project management (5) Quality (5) audits (4) process improvement (4)

đź“Ť Locations

Indianapolis (33) Fishers (5) Plainfield (1)
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Incog Biopharma Services

Document Control Supervisor Fishers
Skills & Focus: Document Control, Quality Assurance, Training, GxP, Regulated industry, Electronic document management, Technical writing, Customer service, Inspection readiness, Records management
About the Company: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building lo…
Experience: Minimum of 2 years experience in a regulated industry, 1 year within the Pharmaceutical industry.
Inspection & Packaging Equipment Specialist, 2nd Shift Fishers
Skills & Focus: pharmaceuticals, GMP, production equipment, sterile, biologics, manufacturing, troubleshooting, process improvements, quality, leadership
About the Company: INCOG BioPharma has built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term…
Experience: High School diploma and 7 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.

Incog Biopharma

Equipment Specialist, 2nd Shift Fishers
Skills & Focus: pharmaceutical, GMP, equipment, manufacturing, aseptic, cleanrooms, troubleshooting, production, validation, engineering
About the Company: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building lo…
Experience: High School diploma and 7 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.

Incog Biopharma Services

Quality Assurance Operations Manager Fishers
Skills & Focus: Quality Assurance, biopharma, aseptic manufacturing, cGMPs, audits, process improvement, training, team leadership, compliance, regulatory requirements
About the Company: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building lo…
Experience: Minimum of 8 years of Quality Assurance experience in biopharma aseptic manufacturing industry. 5+ years of experience as a people leader or supervisor.
Inspection & Packaging Team Lead Fishers
Skills & Focus: inspection, packaging, sterile drug products, cGMP, production standards, quality systems, team leadership, documenting, defect identification, collaboration
About the Company: At INCOG BioPharma we are building a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building …
Experience: minimum 2 years of GMP pharmaceutical experience in drug product inspection and/or packaging

Iqvia

Business Systems Configuration Analyst Indianapolis
Skills & Focus: Business Systems, Configuration, Reporting, Data Integration, Low Code, Planview, LIMS, User Requirements, Client Requirements, GxP Compliance
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Two (2) years of experience supporting low code system implementations.
Salary: $87,000.00 - $145,000.00
Type: Full-time
Benefits: Comprehensive benefits programs designed to meet diverse well-being needs.
Business Systems Configuration Analyst Indianapolis
Skills & Focus: Business Systems, Configuration, Reporting, Data Integration, Low Code, Planview, LIMS, User Requirements, Client Requirements, GxP Compliance
About the Company: IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industrie…
Experience: Two (2) years of experience supporting low code system implementations.
Salary: $87,000.00 - $145,000.00
Type: Full-time
Benefits: Comprehensive benefits programs designed to meet diverse well-being needs.

Cognizant

Lead Automation Engineer Indianapolis
Skills & Focus: Automation, Pharmaceutical, Delta V, DCS, Project Management, Technical Leadership, Software Development Life Cycle, Collaboration, GMP, Regulatory Compliance
About the Company: Cognizant is one of the world's leading professional services companies, redefining clients' business, operating, and technology models for the digital era.
Experience: 10+ years working Automation experience in the Pharmaceutical Industry
Salary: $66,896–$132,500
Type: Full-time
Benefits: Medical/Dental/Vision/Life Insurance, Paid holidays plus Paid Time Off, 401(k) plan and contributions, Long-term/Short-…

Precision For Medicine, Manufacturing Solutions

CQV Engineering Consultant Indianapolis
Skills & Focus: CQV Engineering, life science, project management, validation life cycle, SOPs, client project initiatives, mentoring, business development, technical documentation, quality compliance
About the Company: The leading advanced therapy technical operations consulting company in the life science industry, committed to advancing manufacturing to achieve operational …
Experience: A minimum of 3 years of Project Engineer, Consulting, and/or relevant industry experience.
Salary: $50,000 - $240,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective you…

Project Farma

Consultant Indianapolis
Skills & Focus: biomanufacturing, project management, validation, quality/compliance, engineering, client management, business development, problem solving, teamwork, customer focused
About the Company: Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry, providing biomanufacturing strategy an…
Experience: A minimum of 3 years of Project Engineer, Consulting, and/or relevant industry experience
Salary: Competitive salary based on experience
Type: Full-time
Benefits: Aggressive bonus structure, Medical, Dental, and Vision insurance effective the first day of employment, 401k Plan with…

Parexel

Regulatory Affairs Jobs Indianapolis
Skills & Focus: Regulatory Affairs, Consulting, Clinical Research, Functional Service Provider, Medical Device, Labeling Operations, Home Based, Senior Regulatory Affairs Consultant, Remote, CAGT

Azenta Life Sciences

Quality Associate Indianapolis
Skills & Focus: Quality, GxP, audits, SOPs, Quality Assurance, Continuous Improvement, FDA, analytical skills, communication skills, teamwork
About the Company: Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. The company provi…
Experience: Preferred 1 year minimum of Azenta Life Sciences experience.
Type: Full-time

Project Farma

Project Engineer Indianapolis
Skills & Focus: Technical Delivery, Biomanufacturing, Project Management, Cell and Gene Therapy, Validation Life Cycle, Quality, Regulatory, Compliance, Engineering Automation, Patient Focused
About the Company: Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry, providing biomanufacturing strategy an…
Experience: 0-3 years of consulting and/or project engineer experience
Salary: Competitive salary based on experience
Benefits: Competitive salary, aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan with company match, Pa…

Azenta Life Sciences

Quality Associate Indianapolis
Skills & Focus: Quality Associate, GxP practices, audits, Good Laboratory Practices, Good Manufacturing Practices, Quality Improvement, Compliance, Analytical skills, SOPs, Quality Assurance
About the Company: Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market l…
Experience: Preferred 1 year minimum of Azenta Life Sciences experience.

Genezen

Quality Assurance Position Indianapolis
Skills & Focus: Quality Assurance, cGMP, SOP, Pharmaceutical, Aseptic Processing, Regulatory Compliance, Cleanroom, Change Management, Root Cause Analysis, Clinical Trials
About the Company: Genezen is a growing company in the gene therapy field that provides process development, GMP viral vector production, and cell transduction for clinical trial…
Experience: 3-5 years in a Pharmaceutical or Biologics industry in a Quality Assurance role
Benefits: Paid vacation days, paid sick time, 10 observed holidays, 401(k) plan with company match, Share Appreciation Rights, ch…

Azenta Life Sciences

Quality Manager Indianapolis
Skills & Focus: Quality Manager, Quality Assurance, QMS, Compliance, Internal Audit, Continuous Improvement, Performance Management, Team Management, Regulatory Requirements, Life Sciences
About the Company: Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We provide unpara…
Experience: 4 years of Quality Assurance related work experience required. Life sciences preferred.
Type: Full-time

Federal Express Corporation

Healthcare Quality Advisor-1 Indianapolis
Skills & Focus: healthcare, quality assurance, management, project management, continuous improvement, business, transportation, logistics, supply chain, compliance
Experience: Five (5) years’ minimum experience required in healthcare quality
Salary: Indianapolis Pay Range: $6,511.62/month - $8,627.89/month; Newark Pay Range: $7,882.48/month - $10,444.28/month
Type: Full Time
Benefits: health, vision and dental insurance, retirement, and tuition reimbursement

Precision For Medicine, Manufacturing Solutions

Project Engineer Indianapolis
Skills & Focus: cross-functional collaboration, engineering life cycle, project deliverables, technical documents, system validation protocols, GxP best practices, critical thinking, problem-solving skills, internal and external relationships, patient focused mission
About the Company: The leading advanced therapy technical operations consulting company in the life science industry, committed to advancing manufacturing to achieve operational …
Experience: A minimum of 1 year of Project Engineer, Consulting, and/or relevant industry experience.
Salary: $60,000 - $75,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, aggressive bonus structure, medical, dental, and vision insurance, 401k plan wi…

Cardinal Health

Sr. Specialist, Quality Assurance Indianapolis
Skills & Focus: Quality Assurance, GMP compliance, root cause analysis, corrective actions, regulatory requirements, FDA, pharmaceutical, working knowledge, Document Management software, relevant regulations
Experience: 2+ years’ experience in related field preferred
Salary: $64,000 - $92,500
Type: Full time
Benefits: Medical, dental and vision coverage, Paid time off plan, Health savings account (HSA), 401k savings plan, Access to wag…

Azenta Life Sciences

Team Supervisor Indianapolis
Skills & Focus: team management, bio sample management, quality compliance, collaboration, operational excellence, coaching, performance management, process improvement, FDA regulated industry, data management
About the Company: Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. They provide auto…
Experience: Bachelor’s Degree + 2 years of people and functional experience OR Associate Degree + 4 years of experience, 2 years must be in a people and functional experience OR HS Diploma + 5 years of experience, 2 years must be people and functional experience OR one year experience as a Team Coordinator at Azenta with no correction action of any type (documented warnings/PIP) within the last 6 months.

Novartis

QA Operations Specialist Indianapolis
Skills & Focus: QA, GxP, cGMP, quality oversight, manufacturing, regulatory interactions, validation, qualification, data integrity, compliance
About the Company: Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare profess…
Experience: 2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations, 1+ years of experience in a quality assurance role

Cardinal Health

Sr. Production Chemist, Nuclear Manufacturing Indianapolis
Skills & Focus: manufacturing, process improvement, quality assurance, employee safety, environmental commitment, radiopharmaceuticals, cGMP compliance, standard operating procedures, documentation, production equipment
About the Company: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. It is involved in manufacturing, quality assurance, and engage…
Experience: At least 2 years of experience working in a GMP manufacturing environment in the pharmaceutical or biotechnology industry.
Salary: $67,500 - $96,400
Type: Full time
Benefits: Medical, dental and vision coverage, Paid time off plan, Health savings account (HSA), 401k savings plan, Flexible spen…
Senior Specialist, Quality Control – Microbiology Indianapolis
Skills & Focus: Quality Control, Microbiology, GMP, Laboratory Operations, Environmental Monitoring, Analytical Testing, Aseptic Processes, Documentation, SOPs, Technical Guidance
Experience: 2-4 years in the pharmaceutical or biotechnology industry
Salary: $67,500 - $96,400
Type: Full time
Benefits: Medical, dental and vision coverage, Paid time off plan, Health savings account (HSA), 401k savings plan, Access to wag…

Keywords

Clinical Trial Labeling Compliance Specialist Indianapolis
Skills & Focus: Change Management, Deviation Management, Compliance, CAPA, Project Management, Root Cause Analysis, Quality Standards, Communication, Process Improvement, Multi-tasking
About the Company: Keywords provides a competitive compensation package, good benefits and a casual, fun, productive and supportive working environment. We empower people to perf…
Salary: $24/hr
Type: Full-time
Benefits: Medical, dental and vision benefits, Paid time off (including sick and select holidays), 401(k) enrollment with 3% empl…

Cardinal Health

Principal Specialist, Quality Assurance Indianapolis
Skills & Focus: Quality Assurance, FDA, regulatory compliance, audit program, risk management, threshold adjustments, documentation, investigatory activities, quality management, cGMP
Experience: 4-8 years of experience, preferred
Salary: $79,300 - $113,800
Type: Full time
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vi…

Parexel

Regulatory Affairs Jobs in Indiana Indianapolis
Skills & Focus: Regulatory Affairs, Consulting, Functional Service Provider, CMC Drug & Device, Labeling Operations, Remote, Senior Regulatory Affairs Consultant, Medical Device, Vice President, Associate

Cai

CQV Engineer Indianapolis
Skills & Focus: CQV Engineering, Commissioning, Qualifications, Validation, Protocol writing, Field verification, Project management, ISPE Baseline Guide 5, Regulated Industry, Troubleshooting
About the Company: CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualificat…
Experience: 4-8 years in commissioning and/or qualification activities in a regulated industry
Type: Full-time
Benefits: Competitive compensation and benefits include: up to 15% retirement contribution, 24 days PTO, 5 sick days per year, he…

Genezen

Downstream Manufacturing Operator Indianapolis
Skills & Focus: GMP, viral vector production, aseptic technique, chromatography, clarification, TFF, cell culture, SOPs, batch records, downstream manufacturing
About the Company: Genezen is a company in the gene therapy field that provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell …
Experience: Minimum 2 years of post-graduation experience in a GMP environment; 2 years of experience operating in a GMP laboratory using aseptic technique; 2 years of experience with at scale Clarification, Chromatography, and TFF platforms.
Type: Full-time
Benefits: Paid vacation days, paid sick time, 10 observed holidays + 2 floating holidays + 1 volunteer day, 401(k) plan with comp…

Precision For Medicine

Engineering Consultant Indianapolis
Skills & Focus: Patient Focused, People First, Manufacturing, Quality, Engineering, Validation, GxP best practices, Project Management, Technical Documentation, Cross-functional collaboration
About the Company: Precision for Medicine, Manufacturing Solutions, is the leading advanced therapy technical operations consulting company in the life science industry, committe…
Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
Salary: $58,000 — $63,000 USD
Type: Full-time
Benefits: Competitive salary, Aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan with company match, Pa…

Precision For Medicine, Manufacturing Solutions

Technical Operations Consultant Indianapolis
Skills & Focus: technical operations, advanced therapy manufacturing, GxP best practices, project management, quality/compliance, validation protocols, cross-functional collaboration, engineering life cycle, client support, patient focused
About the Company: Precision for Medicine, Manufacturing Solutions is the leading advanced therapy technical operations consulting company in the life science industry, committed…
Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
Salary: $58,000 — $63,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective you…

Novartis

Process Expert - Comecer Lines Indianapolis
Skills & Focus: manufacturing, GMP, SOPs, process improvement, quality, safety, training, documentation, deviation investigations, continuous improvement
About the Company: Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare profess…
Experience: 1+ years of experience in a manufacturing environment, preferably in pharmaceutical manufacturing
Type: Full-time

Genezen

Manufacturing Team Leader Indianapolis
Skills & Focus: gene therapy, GMP, vector manufacturing, aseptic processing, process improvements, compliance, EHS, performance management, supervisory experience, cleaning/sanitization
About the Company: Genezen is a fast-growing company in the field of gene therapy, providing process development, GMP viral vector production, and cell transduction for gene and …
Experience: 3 years of related work experience in a GMP environment; 1 year of supervisory experience
Type: Full-time
Benefits: Paid vacation days, paid sick time, observed holidays, 401(k) plan with company match, Share Appreciation Rights, choic…
Mid-Level Engineer Indianapolis
Skills & Focus: gene therapy, engineering projects, project management, continuous improvement, EHS compliance, change management, CQV, GMP, collaboration, workflow optimization
About the Company: Genezen is a company that provides process development, produces GMP viral vectors, and offers cell transduction for gene and cell therapy clinical trials, con…
Experience: 3+ years of engineering/project management experience
Type: Full-time
Benefits: Paid vacation days, paid sick time, observed holidays, 401(k) plan with company match, Share Appreciation Rights, healt…

Cai

CQV Engineer Indianapolis
Skills & Focus: CQV, Commissioning, Qualification, Validation, Manufacturing process equipment, Filling, Packaging, Inspection equipment, Problem-solving, Team management
About the Company: CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation,…
Experience: 2-4 years' experience with commissioning, qualification and/or validation preferred
Salary: Competitive compensation
Type: Full-time
Benefits: Competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per…

Novartis

QA Batch Release Specialist Indianapolis
Skills & Focus: quality assurance, batch release, GMP, cGMP, FDA, EU regulations, biopharmaceutical, documentation, CAPA management, cross-functional collaboration
About the Company: Novartis is an innovative medicines company that aims to reimagine medicine to improve and extend people’s lives.
Experience: 2+ years in a GxP Biopharmaceutical manufacturing operations; 1+ years of experience in a quality assurance role
Type: Full-time
Benefits: Compensation and benefits details are provided in the job posting
QA Compliance Specialist Indianapolis
Skills & Focus: Quality Management, GMP, Biopharmaceuticals, Compliance, Health Authority Inspections, Quality Assurance, Training, Data Integrity, Quality Systems, Continuous Improvement
About the Company: Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare profess…
Experience: 6 years of experience in a GMP Biopharmaceutical environment, including at least 2 years of experience in a Quality Assurance role.

Baxter

Quality Associate I, Compliance Indianapolis
Skills & Focus: Quality, Compliance, Hospital, Products, Medical, Healthcare, Manufacturing, Regulatory, Testing, Engineering
About the Company: Baxter provides a broad portfolio of essential renal and hospital products, as well as a leading presence in the changing markets.
Type: Full time

Precision For Medicine, Manufacturing Solutions

Project Engineer Indianapolis
Skills & Focus: Project Engineer, Life Science, Engineering, Validation, Manufacturing, Quality, Supply Chain, Technical Documents, GxP Best Practices, Problem-solving
About the Company: Leading advanced therapy technical operations consulting company in the life science industry, focused on project management, validation, engineering, quality/…
Experience: A minimum of 1 year of Project Engineer, Consulting, and/or relevant industry experience.
Salary: $60,000 - $75,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, aggressive bonus structure, medical, dental, and vision insurance, 401k Plan wi…

Bd

Staff Engineer Distribution Quality Plainfield
Skills & Focus: Quality Engineer, regulatory compliance, product quality, distribution practices, process improvements, audits, training and guidance, data analysis, FDA regulations, ISO standards
About the Company: BD is one of the largest global medical technology companies in the world. Advancing the world of health is their purpose, with a focus on the development, man…
Experience: Minimum five years of experience working in a manufacturing environment.
Salary: $113,400.00 - $186,900.00 USD Annual
Type: Full-Time
Benefits: Healthcare, 401(k)/ Retirement Plans, Professional Development, Paid Time Off, Awards & Recognition