Quality Assurance Compliance Specialist
6 days ago
No C2C Candidates allowed for this role due to client Limitation
Title : Quality Assurance Compliance Specialist (13485 ISO Certified)
Location : Indianapolis, Indiana, United States
Duration : 6+ Months
Shift : 1st Shift
Essential Job Duties:
- Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
- Contributes to global QA policies on interpretation/ application of regulations
- Provide subject matter expertise to projects Support team in CAPA plan creation
- Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses
- Supports the QA–to-QA relationship with key client(s)
- Delivery of training in performance of audits (basic, intermediate, complex)
- Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
- Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Other duties as assigned by management.
- Minimum Required:
- 6 years in regulatory environment (experience in GXP roles)
- Experience of industry quality systems/standards
- Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving
- Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios
Recommended:
- A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
- Would be a 13485 ISO Certified Auditor.
- Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
- Experience may be substituted for education.
- Information purposes only:
- The Drug Development Competencies define the behaviors necessary for the organization to achieve business outcomes.
- Please refer to the Drug Development Competencies for more information about company-wide expectations for all employees.
- Tasks involve sitting in front of a terminal for many hours during the working day.
- Some overtime and weekend work may be required
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
-
Quality Assurance Specialist
6 days ago
Indianapolis, Indiana, United States Net2Source Inc. Full timeJob Title: Quality Assurance SpecialistLocation: LafayetteDuration: 24 Months ContractShift: First ShiftPay rate: $45-$51 an hour on W2Summary:The main function of a Quality Assurance Specialist is to research and test the design, functionality, and maintenance of products, equipment, systems, and processes to develop quality standards. A typical Quality...
-
Senior Quality Assurance Specialist
4 days ago
Indianapolis, Indiana, United States Lilly Full timeJob Summary:We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Lilly. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our products and processes.Key Responsibilities:Lead and mentor quality assurance personnel to ensure compliance with...
-
Quality Assurance Specialist
2 weeks ago
Indianapolis, Indiana, United States FFP Full timeJob OverviewThe Quality Assurance Specialist plays a vital role in ensuring Food Safety and Quality standards are met. This position involves verifying documentation, guiding team members in adhering to best practices, and assisting in root cause analysis. The specialist collaborates with various teams to conduct daily analytical, sensory, and...
-
Sr. Quality Assurance Specialist
2 weeks ago
Indianapolis, United States Accordance Search Group Full timeOur client is seeking a highly skilled and experienced Senior Quality Specialist to join our Quality Assurance team. The ideal candidate will possess a deep understanding of quality engineering principles, regulatory requirements, and risk management processes applicable to the medical device industry. This role requires a proactive individual who is capable...
-
Quality Assurance Compliance Analyst
2 weeks ago
Indianapolis, Indiana, United States Novartis Full timeJob OverviewPosition Summary:This role is a temporary contractor position at Novartis, a company that significantly impacts the health of millions worldwide.About the Role:The Quality Assurance Compliance Analyst is responsible for establishing and maintaining effective Quality Systems in alignment with Novartis and regulatory standards. This position plays...
-
Quality Assurance Specialist
1 week ago
Indianapolis, Indiana, United States Project Lead The Way Full timeJob OverviewThe Quality Assurance Specialist partners with IT personnel to pinpoint discrepancies within business and system specifications, formulate testing strategies, execute test scenarios, and document issues. This position is crucial in guaranteeing that systems and software fulfill quality standards as well as the requirements of clients, both...
-
Quality Assurance Support
2 months ago
Indianapolis, United States Barrington James Full timeQA Support Specialist - On-site (6 Month)I am partnered with a biotechnology research company that is at the forefront of innovative research and development, dedicated to transforming scientific discoveries into impactful healthcare solutions. They are committed to excellence which drives their mission to advance human health and well-being through...
-
Quality Assurance Support
2 months ago
Indianapolis, United States Barrington James Full timeQA Support Specialist - On-site (6 Month)I am partnered with a biotechnology research company that is at the forefront of innovative research and development, dedicated to transforming scientific discoveries into impactful healthcare solutions. They are committed to excellence which drives their mission to advance human health and well-being through...
-
Quality Assurance Specialist
6 days ago
Indianapolis, Indiana, United States FFP Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at FFP. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesQuality Control and Assurance: Conduct regular quality control checks on ingredients, work-in-progress, and finished products...
-
Petroleum Quality Assurance Specialist
2 weeks ago
Indianapolis, Indiana, United States Intertek Full timePetroleum Quality Assurance Specialist at IntertekIntertek is seeking a dedicated Petroleum Quality Assurance Specialist to enhance our team. The successful candidate will be tasked with executing volume and temperature assessments, conducting sampling procedures, performing calculations, and ensuring thorough documentation and reporting to deliver precise...
-
Quality Assurance Specialist
2 weeks ago
Indianapolis, Indiana, United States EnPower, Inc. Full timeJob OverviewThe Quality Assurance Specialist at EnPower, Inc. plays a crucial role in the effective management of the metrology laboratory. Under the guidance of the Senior Quality Engineer, this position encompasses a variety of responsibilities aimed at ensuring the highest standards of quality in our products.Key ResponsibilitiesConduct analyses and...
-
Quality Assurance Specialist
2 weeks ago
Indianapolis, Indiana, United States CECO Environmental Full timeJob OverviewPosition: Quality Control InspectorEmployment Type: Full TimeLocation: Indianapolis, IN, USCECO Environmental is a dynamic and diversified global provider of advanced engineered technologies tailored for the energy, environmental, and industrial sectors. Our focus is on niche markets through a strategic asset-light business model, featuring a...
-
Quality Assurance Specialist
2 weeks ago
Indianapolis, Indiana, United States MBV-CA LLC Full timePosition OverviewThe Quality Assurance Technician plays a critical role in maintaining the integrity of beverage production by conducting thorough quality assurance audits. This position ensures that both company and customer standards are upheld while adhering to all relevant regulations.Key Responsibilities:Conduct regular audits of beverage production to...
-
Indianapolis, Indiana, United States HEALTH AND HOSPITAL CORPORATION Full timeJob SummaryThe Health and Hospital Corporation is seeking a highly skilled and experienced Food Safety and Quality Assurance Supervisor to join our team. As a key member of our Environmental Health department, you will be responsible for supervising field operations, providing guidance and training to staff, and ensuring compliance with food safety...
-
Quality Assurance Manager
5 days ago
Indianapolis, Indiana, United States FFP Full timeJob DescriptionJob Summary:The Quality Assurance Supervisor is responsible for overseeing the quality assurance activities on the production floor, ensuring that all products meet established quality standards and regulatory requirements. This role involves supervising quality assurance teams, conducting audits, managing documentation, and collaborating with...
-
Quality Assurance Specialist
4 days ago
Indianapolis, Indiana, United States FFP Full timeJob OverviewAs a Quality Assurance Technician at FFP, you will play a critical role in ensuring the safety and quality of our products. Your attention to detail and analytical skills will contribute to the overall success of our quality program.Key Responsibilities:Perform inspections and tests on raw materials, work-in-progress, and finished...
-
Quality Assurance Specialist
2 weeks ago
Indianapolis, United States Net2Source Inc. Full timeJob Description: Quality Assurance Data AnalystLocation: Indianapolis, IN 46225Duration: 06+ Months (Extendable)Pay Rate: $43.72/hr. on W2Qualifications:Looking for someone with a strong background in pharmaceutical manufacturing and quality processes and/or laboratory/QC functions, as well as hands on experience with data management, data remediation,...
-
Quality Assurance Specialist
1 week ago
indianapolis, United States Net2Source Inc. Full timeJob Description: Quality Assurance Data AnalystLocation: Indianapolis, IN 46225Duration: 06+ Months (Extendable)Pay Rate: $43.72/hr. on W2Qualifications:Looking for someone with a strong background in pharmaceutical manufacturing and quality processes and/or laboratory/QC functions, as well as hands on experience with data management, data remediation,...
-
Quality Assurance Specialist
2 weeks ago
Indianapolis, United States Net2Source Inc. Full timeJob Description: Quality Assurance Data AnalystLocation: Indianapolis, IN 46225Duration: 06+ Months (Extendable)Pay Rate: $43.72/hr. on W2Qualifications:Looking for someone with a strong background in pharmaceutical manufacturing and quality processes and/or laboratory/QC functions, as well as hands on experience with data management, data remediation,...
-
Healthcare Quality Assurance Specialist
4 days ago
Indianapolis, Indiana, United States Liberty Healthcare Corporation Full timeJoin Liberty Healthcare Corporation's Team of ProfessionalsAbout the Role:We are seeking a highly skilled and experienced Healthcare Quality Assurance Specialist to join our team. As a Quality Reviewer, you will be responsible for conducting onsite reviews to measure regulatory compliance and quality of services at health and human service provider locations...