Quality Assurance Specialist job in North Chicago, IL
Vacancy has expired
North Chicago, IL CorTech LLC
| Job Ref: | 344053 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 33.33/Per Hour |
| Remote: | No |
Location |
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| City: | North Chicago, IL |
| Post Code: | 60064 |
| Map: |
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Description |
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CorTech is seeking to hire a Quality Assurance Specialist for our client in North Chicago, IL! Benefits Available! Weekly Pay! $33.33/Hour Start Time (AM/PM) 8am End Time (AM/PM) 4:30pm This position is NonExempt. Hours over 40 will be paid at Time and a Half. Performs data and document audits to ensure application integrity, accuracy, consistency and completeness. Prepares and issues final audit reports summarizing findings and noting corrective action. ?Design/Change Control - Responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity. ?Risk Management ? Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA?s, etc. ?Design Verification/Validation ? Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records. ?Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty. ?Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management. ?Quality Engineering ? Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products. ?Apply quality principles, analyzes quality records, prepares reports and recommends improvements. ?Conduct inspection, verification and validation of components or materials used in development processes. ?Document quality issues and performance measures for management review. EDUCATION AND EXPERIENCE YOU?LL BRING Required Bachelor?s Degree Required Preferred Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11 Skills Technical: ESI MS, MALDI MS, LC-MS, HPLC, Gel Electrophoresis, ELISA, RT-PCR, Western Blot, UV-Vis Spectroscopy, Architect IA/CC and Alinity i/c/m instrument platform Software and Analysis: flexAnalysis, Microsoft Office (Excel, PowerPoint), SigmaPlot, MATLAB, JMP Communication: Fluent in Polish Top Requires; Design verification experience, protocol reviews and approvals, Excel (pivot tables are very helpful for this type of data analysis), design output/transfer, and design validation. | |
ref: (344053)
1099 days ago
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