- 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
- 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
- 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
-
Quality Assurance Manager
3 days ago
Harba Solutions Inc. IndianapolisThe Quality Assurance Manager is responsible for leading quality systems and ensuring compliance with FDA regulations and GMP standards within a pharmaceutical manufacturing environment. · They oversee QA operations, manage a team, and partner closely with manufacturing, validati ...
-
Manager, Core Automated Testing Laboratory
11 hours ago
Labcorp IndianapolisManager for a core automated clinical testing laboratory responsible for day-to-day operations and staff management. · ...
-
Manager, Core Automated Testing Laboratory
11 hours ago
Labcorp IndianapolisManage day-to-day operations and on-time delivery of medical laboratory testing services; · manage equipment, instrument, and personnel to meet regulatory requirements, · commitments to clients and department goals; · engaged in continuous improvement of the department's operatio ...
- Only for registered members Indianapolis
Responsible for leading a team of Quality Assurance Managers across North America to ensure compliance with regulatory standards (AAALAC, IACUC, USDA, CDC). · ...
-
Validation Engineer
21 hours ago
Process Alliance Indianapolis+Job summary · We're hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment. · +BS or MS in Engineering preferredKneat experience requiredExposure to Control Systems, CSV, and Commissi ...
- American Traveler Indianapolis Freelance
+Job summary · American Traveler is seeking a skilled RN for a Progressive Care Unit night shift role requiring 2 years of recent experience and proficiency in cardiac monitoring. · +ResponsibilitiesWork in a Surgical PCU with near-ICU acuity at a teaching hospitalPatient populat ...
-
Travel Progressive Care Unit Registered Nurse
19 hours ago
American Traveler Indianapolis FreelanceAmerican Traveler is seeking an experienced RN for a Progressive Care Unit (PCU) telemetry position with weekend flexibility and floating requirements. · ...
-
QA Operations Supervisor
5 days ago
Only for registered members IndianapolisWe are seeking a QA Operations Supervisor to provide hands-on support for shop floor quality oversight and batch release activities while acting as supervisor to the QA Operations Specialists. · The ideal candidate will have a Bachelors' Degree in Life Sciences, chemistry, or rel ...
- American Traveler Indianapolis Freelance
American Traveler is seeking an experienced RN for a Progressive Care Unit night position requiring an IN or compact RN license, Cerner EMR experience, and ACLS/BLS certifications. · ...
- American Traveler Indianapolis
American Traveler is seeking an experienced RN for a Progressive Care Unit (PCU) telemetry position with weekend flexibility and floating requirements. · ...
- American Traveler Indianapolis
American Traveler is seeking a travel nurse RN Med Surg for a travel nursing job in Indianapolis. A nurse RN with IN or compact licensure and recent inpatient experience is required. · ...
- American Traveler Indianapolis
American Traveler is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in Indianapolis. · ...
-
Site Supervisor
4 days ago
Only for registered members IndianapolisJob summary The Site Supervisor will be responsible for safely coordinating custodial / janitorial activities within the assigned program . This includes the company employees and other temporary employees engaged in the program . The Individual will inspect areas , equipment , ...
- American Traveler Indianapolis
American Traveler is seeking an experienced RN for a Neuro ICU position requiring an active IN or Compact RN license and NIHSS certification. · Work in a Neuro ICU within a critical care environment · Patient population includes neuro, medical, surgical, and trauma ICU cases · ...
- American Traveler Indianapolis
American Traveler is seeking a Med/Surg RN with IN or compact licensure and recent inpatient experience for a night shift position requiring weekend flexibility and floating. · ...
-
Kitchen Manager for Bru Keystone
2 days ago
Only for registered members IndianapolisWe are seeking a talented Kitchen Manager to oversee culinary operations within our restaurant. · ...
- American Traveler Indianapolis
American Traveler is seeking a travel nurse RN PCU - Progressive Care Unit for a travel nursing job in Indianapolis. · ...
-
Utilization Review Coordinator
5 days ago
Only for registered members IndianapolisWe're looking for a Utilization Review Coordinator to coordinate patients' services across the continuum of care by promoting effective utilization, monitoring health resources and elaborating with multidisciplinary teams. · Filing documents as needed. · Initial Precertification ...
-
General Superintendent
3 days ago
Clayco IndianapolisThis role will manage the organization and direction of project construction activities and oversee total site management including supervision of client contractors, field engineering, contract administration, cost and schedule, field procurement, · finance and accounting. · ...
-
Cardiology - Noninvasive Physician
1 week ago
Britt Medical Search LLC Defunct IndianapolisJob Opportunity · Seeking a full-time BE/BC Non-Invasive Cardiologist. · Candidates should have interest in heart failure and/or advanced cardiology. · No overnight call responsibilities are required, as APP support and clinical pod structuring allow physicians work collaborative ...
-
Inspector - Resident Project Representative
3 days ago
Only for registered members IndianapolisWe are seeking a knowledgeable and meticulous Resident Project Representative to join our team. · The ideal candidate will possess a strong background in civil engineering, exceptional attention to detail, · and effective communication skills to interact with project stakeholders ...
Quality Assurance Manager - Indianapolis - Harba Solutions Inc.
Description
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
Qualifications
Preferred Qualifications
#J-18808-Ljbffr
-
Quality Assurance Manager
Harba Solutions Inc.- Indianapolis
-
Manager, Core Automated Testing Laboratory
Labcorp- Indianapolis
-
Manager, Core Automated Testing Laboratory
Labcorp- Indianapolis
-
Associate Director, Quality Assurance North America Operations
Only for registered members Indianapolis
-
Validation Engineer
Process Alliance- Indianapolis
-
Travel Progressive Care Unit Registered Nurse
Freelance American Traveler- Indianapolis
-
Travel Progressive Care Unit Registered Nurse
Freelance American Traveler- Indianapolis
-
QA Operations Supervisor
Only for registered members Indianapolis
-
Travel Progressive Care Unit Registered Nurse
Freelance American Traveler- Indianapolis
-
Travel Progressive Care Unit Registered Nurse - 2,109 per week
American Traveler- Indianapolis
-
Travel Medical-Surgical Registered Nurse - 2,109 per week
American Traveler- Indianapolis
-
Travel Progressive Care Unit Registered Nurse - 2,109 per week
American Traveler- Indianapolis
-
Site Supervisor
Only for registered members Indianapolis
-
Travel Neuro ICU Registered Nurse - 2,109 per week
American Traveler- Indianapolis
-
Travel Medical-Surgical Registered Nurse - 2,109 per week
American Traveler- Indianapolis
-
Kitchen Manager for Bru Keystone
Only for registered members Indianapolis
-
Travel Progressive Care Unit Registered Nurse - 2,181 per week
American Traveler- Indianapolis
-
Utilization Review Coordinator
Only for registered members Indianapolis
-
General Superintendent
Clayco- Indianapolis
-
Cardiology - Noninvasive Physician
Britt Medical Search LLC Defunct- Indianapolis
-
Inspector - Resident Project Representative
Only for registered members Indianapolis