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À propos
Location: Los Angeles, CA
Duration: 6 months Contract
Job Summary:
This position will be responsible for workflow management and review of change control documentation and documents in the document management system, issuance of production work/support orders, tracking pending tasks in electronic quality management system and coordinate/follow up for completion.
Essential Job Duties:
Responsible for review and workflow management of change control records in electronic Quality Management System (Veeva)
Responsible for review of change control and associated requirements documentation for accuracy, completeness, compliance with cGMPs and applicable standards
Will generate reports on a scheduled basis for the status and tracking of open change control records
Responsible for follow-up on status/open items related to change control
Responsible for issuance of tag-outs for equipment/facilities as required by change control
Generate reports and data for Key Performance Indicator reporting
Coordinate and follow up to ensure timely completion of change control requirements for shutdown projects including authorization of area back to production and product release
Responsible for processing and maintenance of documents in Document Management System managing workflows of review, approval, issuance, and effective
Assist as needed for projects related to document management systems and change control
Familiar with Microsoft Excel, eQMS, Access to utilize for tracking, trending, and data entry
Communicate effectively with multiple departments in order to provide customer service
Job Requirements:
Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience. Related cGMP industry experience is desirable
Experience working with eQMS highly desirable
Ability to keep neat, accurate and complete records and logs
Must be proactive, results oriented, with a strong attention to detail
Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment
Strong organizational, analytical, troubleshooting and problem-solving skills
Ability to analyze details and perform structured decision-making on a daily basis
Excellent verbal and written communication. Must be able to read, write, and speak English
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, Access, etc.
Compétences linguistiques
- English
Avis aux utilisateurs
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