100,000's of Government Jobs

Search Government Jobs

Job Field: Government Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

---

Senior Quality Engineer October 30, 2012 - December 31, 2012 Location: Salt Lake City, UT Salary Range: DOE Exempt/Non-Exempt: Exempt Benefits: Yes Employment Type: Full Time Employer: Cephalon, Inc. Duties: Primary Responsibilities: Reviews and approves of any of the following: ? Protocols/Discrepancies for Validation (Including Computer SystemValidation, 21CFR, Part 11, Equipment, Process, Production) ? Methods and Specifications ? Process/Facility/Engineering Change documentation (QDocs, Trackwise) ? Deviations, Investigations, and Lab Inquiries ? Procedures ? Lab Inquiries/OOS Investigations ? Process, cleaning, method validation protocols, reports and discrepancies ? Equipment/facilities qualifications, protocols/reports ? Specifications, methods ? Facility controls/instrument and procedures Secondary Responsibilities: ? Uses data trends to work with operating departments to facilitate process improvements and lean concepts ? Leads cross functional improvement and process monitoring teams to mitigate unfavorable trends ? Leads scheduled and unscheduled audits of operational areas. ? Provides backup to Record Review for final review/release of production batch records. ? Provides first response and ongoing QA Presence for Quality and Compliance issues on the manufacturing floor and the laboratories ? Contributes to a motivating work environment, where superior performance is defined, supported, rewarded and recognized. ? Leads external and internal audits Qualifications: Requirements: ? A Bachelor s Degree in Science or Engineering with at least 10 years of QA experience in the Pharmaceutical related industry, or equivalent. Must have Solid Dose manufacturing experience ? Must be experienced at creating performance metrics, having performed the corresponding analysis and reports. ? Experience with management of partner relationships required ? Experience with the handling of deviations, investigations, and CAPAs required. ? Excellent computer systems and MS Office skills with working knowledge of computer relational databases. Working knowledge of TrackWise, SAP, LIMS/Labware and statistical software a plus. Crystal Reports highly desirable. ? Detail oriented, team player with strong interpersonal skills. ? Demonstrated working knowledge of cGMP and applicable regulatory requirements. ? ASQ CQE/CQA certification a plus. Click Here to Download Complete Job Description

KEY REQUIREMENTS:

---

None