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| Employer Name: |
SpiderID: 2053272 |
| Location: Hayward, California |
Date Posted: 8/23/2007 |
| Wage: |
Category: Laboratory Technician |
| Job Code: 434316 |
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Job Description:
• Design (or improve) tracking databases that support the Quality Systems utilized by QA, such as databases for DR, CCR, Training, and Internal & External Auditing systems. Ensure that database access is controlled, data is routinely backed-up and that all authorized database users are properly trained. Routinely audit the databases against hardcopy logs/documents to ensure their accuracy and completeness. Ensure databases are up to date with respect to employee hires/departures and process changes that impact the data or the data collection requirements.
• For newly proposed Quality Systems, review data collection/reporting requirements with QS initiator/owner and assist them in the development of a User Requirement Specification to formally define the system's data management requirements. Ensure that proper hardcopy documentation (e.g. logbook) is established for non-Part 11 compliant systems (tracking databases).
• Utilize the above databases to generate reports, graphs, tables and updates in support of:
Routine Operations meetings and reports (daily huddle, HLT, QA monthly report), quarterly and annual progress reviews, regulatory submissions, and investigations or inquiries.
• Routinely provide a data analysis summary with investigations or inquires and other data requests, as appropriate.
• Perform periodic analysis and review of the data contained within these databases and alert QS owner of any potential trends, with an aim to discovery prior to significant product or process impact.
• Recommend and implement new data presentation formats to allow better quality data/metrics review.
• Oversee the administration of eDocCompliance (Qumas) system ensuring that access is controlled to trained, authorized personnel only; changes are reviewed/approved, as per procedure; system disruption/downtime is minimized; response to customers is prompt and courteous; and customer input is sought for continual improvement process.
• Oversee the administration of the Computer Related System (CRS) Change Control system. Perform QA review of proposed changes for completeness prior to approval routing.
• Participate, as QA representative, on project teams involved in software installations, modifications or upgrades. Perform QA review and approval of software validation protocols. Assist in the review of software validation final reports and other documentation required, as per CGI's Software Development Life Cycle (SDLC).
• Other functions include, but are not limited to, the following:
• Perform QA review and approval of Calibration Out-of-Tolerance (OOT) reports. Ensure OOT reports contain sufficient information to assess product impact and alert QA Operations to any OOTs that are deemed to have a potential impact.
• Support QA Compliance in the performance of internal audits, as requested.
• Serve as back-up to QA Compliance Manager in the review/approval of SOPs, validation protocols or product complaints.
• Serve as back-up to QA Operations Manager in the review/approval of deviations, utility shutdown notifications or out of service notifications.
• Assist QA Director in hosting regulatory or due diligence inspections. Oversee the timely response and follow-up to any observations.
Job Requirements:
• BS degree, scientific discipline with at least 8 years experience in QA for a regulated industry, pharmaceutical or medical device experience preferred.
• Experience in database design a must, Microsoft Access experience preferred.
• Ability and experience in leadership of staff.
• Thorough, in-depth knowledge of GMPs and related FDA guidelines.
• Strong prioritization and organization skills.
• Excellent verbal and written communication skills.
• Experience with implementation of software systems, highly desirable.
To apply for this position - Please click the "Apply" button below - OR - send your resume via email to: nwrpros1@vurvexpress.com with QA Manager (434316) in the Subject line.
Job Criteria:
Start Date:
Position Type: Contractor
Years of Experience Required: 8
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - - |
Company Type: |
| Company: NorthWest Recruiting Professionals, Inc |
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| City: Seattle |
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| State: Washington |
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| Zip: |
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Web Site: http://www.nwrpros.com
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