Job Description

Job Title: QA Coordinator

Location: Los Angeles, CA

Duration: 12Months contract (Potential temp to Perm)

Payrate: $35/hr. - $42/hr.

Shift: 1st shift, Mon-Fri

Start Date: ASAP

Job Summary:

This position will be responsible for workflow management and review of change control documentation and documents in 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 is 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 ethics 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.

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