Stefanini, Inc
Overview
Join us to co-create solutions for a better future! Job Details
Quality Assurance Quality Associate II — Round Lake, IL Posted: 10/29/2025 Job Description Job ID#: 62037 Job Category: Quality Assurance Position Type: Contract Duration: 12 months Shift: 1 Remaining Positions: 2 Details:
Stefanini Group is hiring! Exciting opportunity awaits, let us help you get started! Contact: 248-263-5646 or email Ghanshyam Sharma (Ghanshyam.Sharma@stefanini.com) for faster processing.
Responsibilities Responsible for providing quality support and oversight via direct staff supervision or process/area responsibilities.
Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.
Lead ongoing, daily departmental operations; supervise assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; interview/hire, evaluate, train and develop direct reports.
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
Conduct assessments via interviews, flow charting and other information gathering techniques.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish goals and influence actions.
Determine the logic, adequacy and effectiveness of processes, systems and related requirements; develop plans to correct identified risks including areas of non-conformance.
Inform management and implement approved corrective action plans.
Serve as Subject Matter Expert (SME) with expertise in current regulatory requirements.
Provide training and coaching to local employees and others as needed in relevant areas.
Assist other Quality areas in the successful performance of related activities when required.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet corporate, divisional, plant, and regulatory requirements.
Participate in external assessments and audits; evaluate and solve product/process problems with technical, analytical and supervisory skills.
Support the process with timely closure of observations/audit items.
Oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.).
Participate in QA/QC multi-site projects as contributor, coordinator or lead.
Other duties, tasks or projects as assigned.
Qualifications Strong interpersonal skills and great attention to detail; must be a strong team player with good problem solving and verbal and written communication skills.
Ability to manage people, encourage teamwork and drive decisions; able to handle multiple projects concurrently.
Computer experience; knowledge of FDA Regulations, Good Laboratory Practices, and Good Manufacturing Practices.
Education and Experience BS in business/science or equivalent.
3-5 years of experience in Quality with a medical focus.
Salary and About Stefanini Group
Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives. Pay Range:
$30.00 - $33.50 The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises worldwide. Our presence spans the Americas, Europe, Africa and Asia, serving more than 400 clients across multiple industries.
Application and Notice
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Join us to co-create solutions for a better future! Job Details
Quality Assurance Quality Associate II — Round Lake, IL Posted: 10/29/2025 Job Description Job ID#: 62037 Job Category: Quality Assurance Position Type: Contract Duration: 12 months Shift: 1 Remaining Positions: 2 Details:
Stefanini Group is hiring! Exciting opportunity awaits, let us help you get started! Contact: 248-263-5646 or email Ghanshyam Sharma (Ghanshyam.Sharma@stefanini.com) for faster processing.
Responsibilities Responsible for providing quality support and oversight via direct staff supervision or process/area responsibilities.
Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.
Lead ongoing, daily departmental operations; supervise assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; interview/hire, evaluate, train and develop direct reports.
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
Conduct assessments via interviews, flow charting and other information gathering techniques.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish goals and influence actions.
Determine the logic, adequacy and effectiveness of processes, systems and related requirements; develop plans to correct identified risks including areas of non-conformance.
Inform management and implement approved corrective action plans.
Serve as Subject Matter Expert (SME) with expertise in current regulatory requirements.
Provide training and coaching to local employees and others as needed in relevant areas.
Assist other Quality areas in the successful performance of related activities when required.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet corporate, divisional, plant, and regulatory requirements.
Participate in external assessments and audits; evaluate and solve product/process problems with technical, analytical and supervisory skills.
Support the process with timely closure of observations/audit items.
Oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.).
Participate in QA/QC multi-site projects as contributor, coordinator or lead.
Other duties, tasks or projects as assigned.
Qualifications Strong interpersonal skills and great attention to detail; must be a strong team player with good problem solving and verbal and written communication skills.
Ability to manage people, encourage teamwork and drive decisions; able to handle multiple projects concurrently.
Computer experience; knowledge of FDA Regulations, Good Laboratory Practices, and Good Manufacturing Practices.
Education and Experience BS in business/science or equivalent.
3-5 years of experience in Quality with a medical focus.
Salary and About Stefanini Group
Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives. Pay Range:
$30.00 - $33.50 The Stefanini Group is a global provider of offshore, onshore and near shore outsourcing, IT digital consulting, systems integration, application and strategic staffing services to Fortune 1000 enterprises worldwide. Our presence spans the Americas, Europe, Africa and Asia, serving more than 400 clients across multiple industries.
Application and Notice
If you already have an account, log in here.
#J-18808-Ljbffr