Stefanini Group
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Location: Arlington Heights, IL
Job Description 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.
Leads ongoing, daily departmental operations.
Supervise assigned personnel to achieve defined quality goals; 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.
Gather information through employee interviews, flow charting and other techniques.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary 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) by maintaining a high level of 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 these activities.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet corporate, divisional, plant, regulatory requirements.
Participate in external assessments and audits by evaluating and solving product/process problems with technical, analytical and supervisory skills.
Support 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 assigned.
Qualifications
Strong interpersonal skills and great attention to detail.
Strong team player with problem solving skills.
Good verbal and written communication skills.
Ability to manage people, encourage teamwork and drive decisions.
Ability to handle multiple projects concurrently.
Computer experience and knowledge of FDA regulations, Good Laboratory Practices, and Good Manufacturing Practices.
Education & Experience
BS in business/science or equivalent.
3-5 years experience in Quality with a medical background.
Salary & Benefits *Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives.*
About Stefanini Group 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 around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with global presence. We are CMM Level 5 company.
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Location: Arlington Heights, IL
Job Description 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.
Leads ongoing, daily departmental operations.
Supervise assigned personnel to achieve defined quality goals; 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.
Gather information through employee interviews, flow charting and other techniques.
Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary 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) by maintaining a high level of 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 these activities.
Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet corporate, divisional, plant, regulatory requirements.
Participate in external assessments and audits by evaluating and solving product/process problems with technical, analytical and supervisory skills.
Support 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 assigned.
Qualifications
Strong interpersonal skills and great attention to detail.
Strong team player with problem solving skills.
Good verbal and written communication skills.
Ability to manage people, encourage teamwork and drive decisions.
Ability to handle multiple projects concurrently.
Computer experience and knowledge of FDA regulations, Good Laboratory Practices, and Good Manufacturing Practices.
Education & Experience
BS in business/science or equivalent.
3-5 years experience in Quality with a medical background.
Salary & Benefits *Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives.*
About Stefanini Group 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 around the world. Our presence is in countries like Americas, Europe, Africa and Asia, and more than 400 clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with global presence. We are CMM Level 5 company.
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