Quality Assurance Specialist in Ottawa, Illinois at Alimentiv
Recently UpdatedSalary: $78000 - $130000Job Function: Quality Assurance
Alimentiv
Ottawa, Illinois, 61350, United States
Posted on
Explore Related Opportunities
Industrial Production Managers jobs near me in IllinoisJobs near me in IllinoisIndustrial Production Managers jobs
Job Description
Quality Assurance Specialist
$78,000 - $130,000 a year
Responsible for providing senior support in planning, organizing and/or evaluating the day-to-day delivery of global quality assurance (QA) services. Responsible for supporting the business in quality assurance, policy planning and development, ongoing quality improvement through clinical audit and liaison with other business units and external partners. Will also provide support, expertise, and industry best practice guidance.
Quality Assurance Implementation- Implement quality assurance plans and processes and identify indicators needed to assess product/service quality levels.
- Collaborating with management/functional experts or Sponsors to identify requirements of the organization in order to conduct internal audits, site audits, vendor assessments and vendor audits.
- Oversee the development of Quality System documents including policy, procedure, instruction, guidance and form and template development in collaboration with departments and senior management.
- Develop QA processes, train and oversee junior QA staff.
- Liaise with the Human Resources department to ensure that all staff are qualified.
- Remain current on and ensure internal awareness of regulatory trial conduct standards and requirements.
- Identify changes to standards and regulations governing Clinical Research and provide recommendations for implementation as required.
- Remain current on, interpret and communicate changes to regulatory trial conduct standards and requirements.
- Identify, implement and/or develop policies, processes, and/or training to meet these standards.
- Plan/lead/facilitate Sponsor and regulatory inspections and audit activities including preparation of staff, oversight of proceedings and ensure findings addressed are resolved.
- Perform internal audits and vendor assessments, ensuring that all observations are appropriately addressed and resolved.
- Communicate audit findings to internal stakeholders and provide guidance to teams regarding the development of Root Cause Analysis and Corrective Preventive Actions.
- Liaise with other departments in the completion of Sponsor requests for information.
- Support internal departments with privacy related questions or inquiries
- Provide guidance during product/service enhancements cycles or during times of organizational change around quality compliance and cross-functional process requirements and organization efficiency gains.
- The successful candidate will possess either an undergraduate degree with 4-6 years of related experience and on the go training, or a College Diploma with 7-9 years of related experience and training.
- Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred. Strong analytical, critical thinking and problem-solving skills required. Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.
Stay Alert to Recruitment Scams
We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.
We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.
We are proactively seeking QA Specialists for anticipated vacancies in Canada for the coming year.
$78,000 - $130,000 a year
Scan to Apply
Just scan this QR code to apply from your phone.
Job Location
Ottawa, Illinois, 61350, United States
Frequently asked questions about this position
Similar Jobs In Ottawa, Illinois
New
Operations Team Manager I - 2nd shift
Ajinomoto Foods North America, Inc.
Toluca, Illinois
Production Planner
ELAN INDUSTRIES INC
Bolingbrook, Illinois
New
Mgr Operational Excellence
Ajinomoto Foods North America, Inc.
Toluca, Illinois
Digital Print Manager
Amsive
Bolingbrook, Illinois
Senior Product Manager
IDEAL Industries, Inc.
Sycamore, Illinois
Continue to apply
Enter your email to continue. You’ll be redirected to the employer’s application.By clicking Continue, you understand and agree to JobTarget's Terms of Use and Privacy Policy.