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Job Field: Legal Jobs
Location: San Carlos, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Deviation SpecialistJob Type:ContractJob Location:San Carlos                         CaliforniaJob Description:Our client aspires to be the most respected and successful healthcare companies in the world. As the industry evolves, their success depends on continuous advancement and improvement by hiring top talent. As needs increase globally, innovation is the key in providing new and better medicines. Voted as one of the best places to work in New Jersey, start a career with a leader in the pharmaceutical industry!<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />Duties1.Resolves investigations and deviations.2.Performs a wide variety of activities to ensure compliance with applicable GXP requirements.3.Assures all operations are performed in compliance with company procedures and Quality Standards.4.Monitors designated phases of the manufacturing operations.5.Writes and revises standard operation procedures.6.Conduct investigations related to manufactured products.7.Generates reports.8.Applies knowledge of good manufacturing practices daily.Responsibilities1.Participates in the disposition of batches.2.Maintains the cross project support systems which include, material receipt, QA line clearance, area approval, packaging inspection, batch record review, device assembly audit and release and verification of supply shipments.3.Participates and leads quality investigations utilizing QA tools and follows up on corrective actions.4.Reviews data audits and report reviews as required.5.Tracking/trending of manufacturing data including in-process and finished product test results.6.Author Quality SOPs as needed7.Work with line units to author/draft deviation reports related to commercial manufacturing Work in Trackwise QA database (author, search, track, follow-up on Trackwise cases)8. Provides support to other projects as assigned.Skills1.A minimum of 6 years experience in the pharmaceutical industry working in aGMPenvironment is required.2.Experience with writing and leading product manufacturing investigations Experience using Trackwise3.QA database Experience with QA systems, Strong oral and written communication skills are required.4.Must have excellent interpersonal skills.5.Knowledge of FDA regulations and cGMPs for drugs and device are a must.6.Computer literacy (MS Word, Excel).EducationA Bachelors degree in a scientific discipline is recommended with a minimum of 8 years related experience is required.Approx. Duration: 2 monthsAbout Hired By MatrixFor more than 25 years, Hired by Matrix has been providing temporary and long-term contract staffing solutions to Fortune 1,000 as well as mid-market companies nationwide. Our clients include major pharmaceutical, delivery & logistic, business information, financial and entertainment companies. The technology that we support is as diverse as our clients. We provide consultants with experience in mainframe legacy technology all the way to cutting edge technologies, like web and mobile application development. Our consultants are in roles that include Project Managers, Architects, Business analysts, QA, developers and infrastructure & network specialists. At the request of our clients we have broadened our capabilities across a variety of different areas, including: finance and accounting, R&D, clinical sciences and administrative. And as a woman-owned, WBENC-certified business we

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