Charlestown, IN · On-site
$100 - $190/hr
RESPONSIBILITIES Quality Management System * Establish and maintain a Pharmacy Quality Management ... Certified Quality Auditor (CQA) * Six Sigma Green Belt or Black Belt * Experience with electronic ...
New
Charlestown, IN · On-site
$100 - $190/hr
RESPONSIBILITIES Quality Management System * Establish and maintain a Pharmacy Quality Management ... Certified Quality Auditor (CQA) * Six Sigma Green Belt or Black Belt * Experience with electronic ...
New
Columbus, IN · On-site
$70 - $100/hr
Your Responsibilities Quality Management System (QMS):Maintain and improve the site Quality Management System in compliance with ISO 9001, BRCGS, customer, and company requirements. Keep quality ...
New
Columbus, IN · On-site
$70 - $100/hr
Your Responsibilities Quality Management System (QMS):Maintain and improve the site Quality Management System in compliance with ISO 9001, BRCGS, customer, and company requirements. Keep quality ...
New
The technician investigates quality issues, assists with corrective actions, and helps maintain the effectiveness of the quality management system. Responsibilities may also include conducting vendor ...
New
The technician investigates quality issues, assists with corrective actions, and helps maintain the effectiveness of the quality management system. Responsibilities may also include conducting vendor ...
New
The Quality Manager is responsible for the quality management system and monitors and advises on ... management system reports. * Acts as the key contact with customer and third-party auditors.
The Quality Manager is responsible for the quality management system and monitors and advises on ... management system reports. * Acts as the key contact with customer and third-party auditors.
Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing Company ... CAPA systems * Internal auditing * Risk management (ISO 14971 preferred) * Supplier qualification ...
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Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing Company ... CAPA systems * Internal auditing * Risk management (ISO 14971 preferred) * Supplier qualification ...
New
Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing Company ... CAPA systems * Internal auditing * Risk management (ISO 14971 preferred) * Supplier qualification ...
New
Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing Company ... CAPA systems * Internal auditing * Risk management (ISO 14971 preferred) * Supplier qualification ...
New
Fort Wayne, IN · On-site
$71K - $91K/yr
Manage Quality System documentation including procedures, work instructions, forms, process maps ... Lead Auditor certification (IATF 16949 or ISO 9001). Experience supporting surveillance ...
Fort Wayne, IN · On-site
$71K - $91K/yr
Manage Quality System documentation including procedures, work instructions, forms, process maps ... Lead Auditor certification (IATF 16949 or ISO 9001). Experience supporting surveillance ...
Fort Wayne, IN · On-site
$71K - $91K/yr
Responsibilities align with the organization's quality system processes, management review ... auditors and process owners. • Ensure compliance with record retention, document control, and ...
Fort Wayne, IN · On-site
$71K - $91K/yr
Responsibilities align with the organization's quality system processes, management review ... auditors and process owners. • Ensure compliance with record retention, document control, and ...
Fort Wayne, IN · On-site
$63K - $82K/yr
Responsibilities align with the organization's quality system processes, management review ... auditors and process owners. • Ensure compliance with record retention, document control, and ...
Fort Wayne, IN · On-site
$63K - $82K/yr
Responsibilities align with the organization's quality system processes, management review ... auditors and process owners. • Ensure compliance with record retention, document control, and ...
The Quality Specialist plays a key role in our Quality department! Join us as we provide ... Teaches process improvement theory, tools and techniques to others within the healthcare system.
The Quality Specialist plays a key role in our Quality department! Join us as we provide ... Teaches process improvement theory, tools and techniques to others within the healthcare system.
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... Lead Auditor, ASQ CQE, CQA) preferred KNOWLEDGE & EXPERIENCE 7+ years of experience in Quality ...
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... Lead Auditor, ASQ CQE, CQA) preferred KNOWLEDGE & EXPERIENCE 7+ years of experience in Quality ...
Terre Haute, IN · On-site
The Quality Specialist plays a key role in our Quality department! Join us as we provide ... Teaches process improvement theory, tools and techniques to others within the healthcare system.
Terre Haute, IN · On-site
The Quality Specialist plays a key role in our Quality department! Join us as we provide ... Teaches process improvement theory, tools and techniques to others within the healthcare system.
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... Auditor, ASQ CQE, CQA) preferred KNOWLEDGE & EXPERIENCE • 7+ years of experience in Quality ...
... Quality Management System (QMS) within a hands-on manufacturing environment. This role ensures ... Auditor, ASQ CQE, CQA) preferred KNOWLEDGE & EXPERIENCE • 7+ years of experience in Quality ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Auditing & Continuous Improvement Perform ISO Internal process audits and supplier quality ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Auditing & Continuous Improvement Perform ISO Internal process audits and supplier quality ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Auditing & Continuous Improvement Perform ISO Internal process audits and supplier quality ...
Summary The Quality and Training Specialist supports the organization'sQuality Management System ... Auditing & Continuous Improvement Perform ISO Internal process audits and supplier quality ...
DUTIES & RESPONSIBILITIES · Own and maintain the company's Quality Management System (QMS) within ... Auditor, ASQ CQE, CQA) preferred KNOWLEDGE & EXPERIENCE · 7+ years of experience in Quality ...
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DUTIES & RESPONSIBILITIES · Own and maintain the company's Quality Management System (QMS) within ... Auditor, ASQ CQE, CQA) preferred KNOWLEDGE & EXPERIENCE · 7+ years of experience in Quality ...
Terre Haute, IN · On-site
The Quality Specialist plays a key role in our Quality department! Join us as we provide ... Teaches process improvement theory, tools and techniques to others within the healthcare system.
Terre Haute, IN · On-site
The Quality Specialist plays a key role in our Quality department! Join us as we provide ... Teaches process improvement theory, tools and techniques to others within the healthcare system.
Bluffton, IN · On-site
$16.25 - $22/hr
The Quality Control Technician provides support for the Quality Management System (QMS) through auditing and documentation development, and supports process improvements through a cross-functional ...
Bluffton, IN · On-site
$16.25 - $22/hr
The Quality Control Technician provides support for the Quality Management System (QMS) through auditing and documentation development, and supports process improvements through a cross-functional ...
... Auditor Certification preferred * Strong knowledge of ISO 9001:2015 and/or IATF 16949 Quality Management Systems * Proven experience leading quality audits and corrective action processes * Strong ...
... Auditor Certification preferred * Strong knowledge of ISO 9001:2015 and/or IATF 16949 Quality Management Systems * Proven experience leading quality audits and corrective action processes * Strong ...
Indianapolis, IN · On-site
$95 - $130/hr
The Lead Internal Auditor plays a pivotal role in ensuring that clinical research laboratory ... Experience with quality management system and regulatory compliance inspections. * Experience ...
New
Indianapolis, IN · On-site
$95 - $130/hr
The Lead Internal Auditor plays a pivotal role in ensuring that clinical research laboratory ... Experience with quality management system and regulatory compliance inspections. * Experience ...
New
$16.40 is the 25th percentile. Wages below this are outliers.
$12.12 - $23.41
66% of jobs
$29.23 is the 75th percentile. Wages above this are outliers.
$23.41 - $34.71
18% of jobs
$34.71 - $46
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1% of jobs
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3% of jobs
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4% of jobs
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A Quality Management System (QMS) Auditor is responsible for evaluating an organization's quality management processes to ensure compliance with industry standards, regulations, and internal policies. They conduct audits, review documentation, identify nonconformities, and recommend corrective actions to improve efficiency and compliance. QMS Auditors work in various industries, such as manufacturing, healthcare, and technology, and often need certifications like ISO 9001 Lead Auditor. Their role helps organizations maintain consistency, enhance product or service quality, and meet customer and regulatory requirements.
To thrive as a Quality Management System Auditor, you need a strong understanding of quality standards (such as ISO 9001), process auditing, and document control, often supported by a relevant degree and industry-recognized certifications like ISO Lead Auditor. Familiarity with audit management software, document management systems, and compliance tracking tools is typically required. Attention to detail, analytical thinking, and effective communication skills are critical soft skills for investigating processes and reporting findings. These competencies ensure that audits are thorough, compliance risks are identified, and organizational improvements are consistently achieved.
Quality Management System Auditors often face challenges such as resistance to change from employees, complex or poorly documented processes, and staying updated on evolving regulatory standards. These can be managed by building strong relationships with team members, using clear and constructive communication, and committing to continuous professional development. Adaptability, professionalism, and a solutions-oriented mindset are essential for overcoming obstacles and driving positive process improvements. Being proactive and open to feedback also helps auditors foster a culture of compliance and quality across the organization.
For Quality Management System Auditor jobs in Indiana, the most frequently searched job titles are:
The top searched job categories for Quality Management System Auditor jobs in Indiana are:
$100 - $190/hr
Other
Medical, Dental, Vision, Retirement, PTO
Posted yesterday
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The Pharmacy Quality Assurance Manager is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) supporting specialty pharmacy operations at the facility in Charlestown, Indiana. This role ensures inspection readiness, regulatory compliance, and effective execution of quality systems in alignment with NABP, ACHC, and URAC accreditation standards, applicable provisions of 21 CFR Part 211, and quality system principles aligned with 21 CFR Part 820.
This position owns site quality systems governance and operational quality controls and works in close collaboration with Operations Management.
Must be able to work onsite at our Charlestown, Indiana location Monday-Friday.
Remote work is NOT available for this role.
RESPONSIBILITIES Quality Management SystemEstablish and maintain a Pharmacy Quality Management System consistent with CareTria’s Corporate Quality Management System requirements, NABP, URAC, ACHC, FDA, DEA and client quality expectations.
Own SOP/OWI lifecycle management, document control, record retention, and change control consistent with 21 CFR 211 Subpart B and quality system principles of 21 CFR 820.
Lead quality metrics, management review, and continuous improvement initiatives.
Ensure compliance with NABP, URAC, ACHC, state Boards of Pharmacy, DEA regulations, USP <800>, USP <1079>, DSCSA, and applicable sections of 21 CFR Part 211.
Prepare for and support inspections and audits (Boards of Pharmacy, NABP, URAC, ACHC, manufacturers, clients).
Facilitate process deviation investigations, root cause analysis, and CAPA in alignment with 21 CFR 211.192 and Part 820 quality system expectations.
Ensure CAPAs are risk-based, effective, and documented.
Support client presentations and interactions relating to CAPAs and quality oversight
Implement quality controls across fulfillment, dispensing support activities, packaging, labeling, cold chain, storage, and distribution.
Partner with Operations to embed error prevention and standardized workflows.
Collaborate with Operations management to translate clinical risk into operational controls.
Partner with IT/IR on systems impacting data integrity, labeling, and workflow controls.
Bachelor’s degree required; advanced degree preferred.
5–7 years of experience in Quality Operations, Quality Systems, or Regulatory Quality in a FDA regulated or specialty Pharmacy environment.
Experience supporting inspections, audits, investigations, and CAPA programs.
Working knowledge of NABP, URAC, 21 CFR Part 211, and quality system principles aligned with 21 CFR Part 820.
Certified Quality Manager / Organizational Excellence (CQM/OE)
Certified Quality Auditor (CQA)
Six Sigma Green Belt or Black Belt
Experience with electronic QMS platforms
Experience supporting controlled substance programs or DEA audits
The expected base pay range for this position is $100,000 - $190,000/YR. The actual compensation for the position may vary based on market differences and on factors such as skills, experience, qualifications and can vary based on location and/or work schedule. In addition to base pay, CareTria offers a comprehensive benefits package. Full-Time benefits include access to health, dental, and vision insurance; retirement plan options; paid time off; paid parental leave; employee assistance programs; and other perks. Eligible employees may also have access to performance bonuses.
CareTria is an equal opportunity employer
