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Job Details

Quality Compliance Coordinator
Order ID: PWR7576   Job Category: Quality Management, Regulatory, Compliance
Job Begins: Feb 4 2013 Job Ends: Mar 2 2014
City: San Diego State: California
Travel Type: Meeting Type: Both
Requirements:

Title: Quality Compliance Coordinator

Order No: PWR7576

Location: San Diego,CA

Start Date: 4-Feb-2013  End Date: 2-Mar-2014

 

Job description:

 

Title: Quality compliance Coordinator

 

• Coordinates plans necessary for implementation & optimization of the document control process and plans for the execution of the Quality Tracking System required for monitoring the DCR’s, NCMR’s, CAPA, Deviations.

• Participates in reviewing and revising the existing Internal procedures, assisting in Gap Analysis, Compliance Analysis Status (CAS) report for developing the new Quality procedures aligned with client’s quality system requirements.

• Supports activities associated with the process change management and risk management .

• Reviews, prepares and maintains facility documents, blueprints and legends for submission to the USDA or other regulatory agencies .

• Assists in reviewing and updating outline of production (OOP) also new labeling and packaging components for the existing or new products.

• Reviews and complies the new raw materials qualification and supplier qualification programs .

• Performs any other routine tasks in QO department if necessary.

o 3-5 years Experiences in a regulated environment such as USDA or FDA is required.

o Demonstrated ability to work independently besides prioritizing the routine tasks.

*Occasional lifting up to 30 pounds

 

PHYSICAL POSITION REQUIREMENTS

Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements
Required Skills:
Special Notes:
Target Rate: 0.0000
Job Overview

Quality Management, Regulatory, Compliance

Functions Performed:

Serves the QM organization as a primary point of contact for quality support requests from the Business & Informatics to ensure that computerized systems are developed & managed in accordance with corporate, regulatory & Informatics standards. 

 

Work closely with Informatics project managers, teams and associated Business QA groups to ensure SLC deliverables are consistent & satisfy the above requirements and meet business needs. Tasks include writing, revising, and verifying QM deliverables (Quality Planning & Compliance Reporting), reviewing and approval of SLC deliverables (Project planning, requirements and verification).

 

Tasks also include contributing to implementation and post implementation planning and monitoring to support effective performance and change management practices. Excellent communication skills are required, capable of performing effectively within a project team, or with minimal supervision.