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Quality Coordinator
Ref No.: 18-06745
Location: St. Petersburg, Florida
Start Date / End Date: 10/29/2018 to 04/28/2019
Description/Comment: Sr. Quality Coordinator

The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support to the Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.

The position is responsible for maintenance of quality documentation, including executed batch records. The primary tasks performed by this individual are to ensure that the documentation is tracked and properly filed. The position will also respond to internal and external customer requests for quality document copies, and external customer requests for product samples; tracking and trending reports; processing of Certificate of Analysis as needed; assisting in the tracking database for the flow of quality documents; and maintenance and archival of quality documents. This position serves as a liaison between all groups in the Quality organization to ensure smooth coordination of efforts and to drive for results of common goals. The individual is responsible, as assigned, to attend meetings to represent the Quality Unit to gather requests and appropriately communicate to responsible individuals within the Quality organization for follow up. Independent judgment is required to plan, prioritize, and organize diversified workload. May be called upon to work on complex assignments where considerable judgment and initiative are required to resolve problems and make recommendations.

The Senior Quality Coordinator primary role is to manage the flow of Batch documentation through the Quality Unit to ensure product On Time Delivery and project deliverables. Ensure Batch Documentation is received and logged. Maintain 2 File Rooms daily in a state of compliance with current good manufacturing practice regulations. This includes maintaining a spreadsheet for every batch record that is received into the File Room. Review of executed gelatin mass and washing solutions batch records as needed. Work directly with batch record reviewers/releasers when needed to reduce backlog for scheduling and effectively reprioritize review based on business needs. Schedule batch records for releasers for auditing (back-up). Assist functional areas within the Quality Unit with routine duties as needed. Assist Management within the Quality Unit in the preparation, submission for review, and approval process of customer and suppliers Quality Agreements. Interact with QC, Client Services and the Production Customer Focus Teams and other facility departments, to ensure that product is released and shipped to our customers as promised. Interface effectively with internal and external customers, as first responder when needed, and to provide requested information which may include sending Certificate of Analysis for every product that is shipped and other documentation as necessary. Direct contact with customer is expected to meet customer demands. Facilitate the collection of metrics and prepare, as requested, Weekly Metrics for the site. Schedule and coordinate Management Reviews and serve as meeting scribe as requested as per applicable SOPs. Participate, as assigned, in facility projects to drive continuous improvement. Manage activities associated with the collection of documentation and information in preparation and during regulatory inspections, as well as, the coordination of Subject Matter Experts (SMEs) in support of such audits. Send out customer samples daily, as required. Procure office supplies for the Quality Unit. Support the Quality Unit in the generation of corrective work orders. Attend meetings to represent the Quality Unit to gather requests and appropriately communicate to responsible individuals within the Quality organization for follow up. Assist Management in coordinating departmental activities, as needed.
Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North St. Petersburg FL 33716 United States
Additional Job Details: There is the potential for this to transition to an FTE role based on performance. Recent grads with relevant degree Science could be a good match. Computer skills are very important.
Job Qualifications Requires a bachelor's degree in a relevant discipline or equivalent experience, or applicable combination. A technical background in Science is preferred. Recent graduates will be considered.
Knowledge/Skills Requirements: Ability to write, edit and proof business correspondence and reports required. Proven ability to multi-task and demonstrate diplomatic skills. Excellent English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization Interpersonal skills necessary to deal effectively and courteously with both internal personnel and external contacts required.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, customer documents and financial reports.
Ability to effectively present information and respond to questions from groups of managers, and customers
Proficient knowledge of Microsoft programs required (Excel, Word, Access and PowerPoint). Knowledge of Documentum, TrackWise, and JD Edwards preferred
Motivated, self-started, team player.
Physical/Mental Requirements: Ability to work effectively under pressure to meet deadlines with changing priorities and deadlines. Individual required to sit, stand, walk and lift 0-15 pounds. Be accessible to the manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Work Environment:
Individual's primary workstation is located in the office area, where the noise level is low. Employee may occasionally be present on the manufacturing floor or in the lab where the noise level is low to moderate.