Become A Quality Control Coordinator

* Provide Quality Control (QC) documentation support to operations.
* Perform QC review of documentation such as Sample Login binders, run binders, extraction paperwork, Lab notebooks, data tables and reports.
* Participate in review of technical and QC SOPs to ensure compliance with appropriate regulations.
* Participate in QC and company staff meetings and discuss findings and recommendations for resolving non-compliance.
* Work in conjunction with operation individuals to improve quality systems.
* Assist coworkers and manager to manage and schedule all assigned quality control projects.
* May track and report deviation trends to management.
* Demonstrate continuous self-motivated quality development.
* Proactively take steps to improve quality systems

* You will develop and implement procedural changes that have a positive impact on product quality efficiency.
* Monitor process methods related to quality results.
* Research possible non-conformities and provide feedback to responsible departments.
* Clearly understand and maintain the ISO 9001 criteria, standards and documentation throughout the print and production areas.
* You will plan, implement, and follow through on standard methodology activities aimed at the continuous improvement of business practices and ensure these plans are executed successfully.
* You will monitor, communicate and carry out special requests from various other departments that QC has a working relationship with Provide Management with feedback for any quality issues that may have occurred.
* Ensure proper communication is carried out between the Quality Control department and the departments it interacts with (i.e. interacting with the Client Service departments for the purpose of ensuring Client expectations are met or exceeded).
* You will demonstrate your strong leadership abilities to attract and retain appropriate staff, provide mentoring, leadership, training, and career development.
* You'll also reward, recognize and provide constructive feedback to the Quality Control staff.
* Train Quality Control Inspectors and Sr.
* Quality Control Inspectors utilizing a cross-training method and provide them with the resources necessary to succeed within the department and the organization

* This position provides administration support and coordination for the QA Department.
* Maintains consistent output through specified areas and may provide backup supervisory support.
* Helps maintain throughput, procedures, and applicable paperwork, trains department personnel and monitors compliance to established procedures.
* Essential job Functions:
* The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive.
* The omission of a specific duty or responsibility will not preclude it from the position._
* Will coordinate and maintain the non-conformance database which includes; maintaining the database for local and outside non-conformances, communication with Bard facilities, follow up, supplying support to engineers, and preparing weekly meetings.
* Verify the device history records for the in-process areas to assure the records are in compliance and cGMP guidelines are met and product acceptable for release.
* Generate and Report RGL numbers for Quality and operations on monthly bases and prepare the MRR pareto charts for the Quality Council Meeting.
* Generate and approve product certificate of compliance/analysis.
* Interface with support groups, departments, and other shifts to resolve issues.
* Coordinate the quality team meetings and responsible for maintaining meeting minutes and follow up on assigned action items.
* Provides support to management; including budget preparation and monitoring.
* Coordinate and execute team activities for the department.
* Manage the distribution and production holds.
* Maintain all documentation for issued hold per division and corporate standards.
* Identifies inspection concerns/ issues and verifies SOP's are being followed; communicate to QA management.
* Maintain the quarantine cage and coordination of all non-conforming material.
* Assure processes are in compliance with SOP's.
* Conduct cross-training for assigned personnel, as required.
* Responsible for accuracy of paper work and various reporting mechanisms.
* May be required to work in different areas and received additional responsibilities as needed.
* Provides back up when supervisor is not available and assists in the areas as need it

* The incumbent is responsible for the management of several GSK Vaccines analytical lifecycle product, bringing the analytical and stability product expertise to multi-disciplinary Technical teams.
* He/she is responsible for the delivery of QC critical source documents related to files registration, for the management of transversal deviation, for the redaction of the analytical and stability sections of the product quality review, , integrating all analytical aspect of continuous improvement (Vigilance, Technology, and Regulatory Requirement) and supply demands (challenge and adjust analytical development & strategy to support their right application in commercial phase).
* Your responsibilities are:
* Is responsible for the global QC product coordination for life cycle products bringing the analytical expertise to multi-disciplinary Technical teams and task forces.
* Is responsible for the the timely redaction of the analytical and stability section of the product quality review and the coordination of the implementation of identified improvements (CAPA) for the products under his/her responsibility.
* Is responsible for the the timely redaction and approval (before submission) of the QC sections of regulatory files, variations and Question and Answer reports for the products under his/her responsibility.
* Is accountable for providing the intermediate and final QA approved stability reports within the timelines agreed with RA in the frame of variations and commitments.
* Approve and coordinate the QC tasks in the frame of transversal Change control identified within Technical Team,
* Establish the testing and stability strategies for the products under his/her responsibility.
* Is accountable for creating and modifying accordingly the vaccines monographs and stability plans.
* Bring vaccine analytical expertise within the technical teams, integrating all analytical and stability aspects (Vigilance, Technology, and Regulatory Requirement).
* Manage QC critical deviations.
* Ensure that all the technical activities related to the investigation of significant analytical and quality issues are conducted to guarantee the continuity of supply and are in accordance with the current regulations.
* Identify risks on technical feasibility and supply, timing and resources constraints and seek a remediation plan for identified risks and escalade any analytical technical and/or supply issues to the relevant body (project team, escalation, performance tower…) for one product category.
* Consolidate a monthly progress status shared with the key stakeholders.
* Coordinate the alignment of QC labs deliverable link to testing of lifecycle product improvement projects in line with Global supply chain objectives in terms of quality, time and cost.
* Negotiate with the laboratory heads the resources allocation and development activities to achieve the target.
* Collect & Challenge demands for Demand & Planning (QC planning and prioritization tool) purposes for one product (*) category.
* Act as key player during Regulatory inspection and meetings.
* Present and defend analytical and stability strategies for the products under his/her responsibility, during GMP inspections (FDA, EMEA, other national authorities, GSK corporate,…)
* Our Offer:
* At GSK, we provide a supportive working environment, and a range of development challenges and opportunities.
* We also offer competitive benefits and compensation packages designed to attract and to retain the very best.
* GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.
* GSK is an equal opportunity employer.
* The Department:
* Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
* The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance.
* The scope covers any action that potentially impacts final product quality.
* The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
* Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
* Why You

* Perform equipment/truck maintenance
* Schedule and coordinate jobs
* Perform QA field audits / safety audits
* Perform Level II work in the field
* Communicates with clients and staff on a daily basis
* Works closely with other business unit departments / office coordination
* of time performing Level II field work
* of time dealing with other responsibilities listed above