Quality Management Systems Specialist

CoWorx Staffing Services has an exciting opportunity for a Quality Management System Specialist working with one of our premier clients in Griffin, GA. This is a direct hire opportunity. You will be responsible for a variety of Quality Management (QMS) processes and software: especially Corrective and Preventive Action (CAPA), internal and external audit, and various quality continuous improvement activities.

Main Duties and Responsibilities:

• Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepare reports and/or necessary documentation (ex: Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Coordinate legal requests in support of government investigations or litigations.
• Ensure the quality assurance programs and policies are maintained and modified regularly.
• Facilitate uniform standards for the site and enables best practice sharing, thereby fostering the achievement of company's mission.
• Management and facilitation of quality documentation system.
• Work within a GMP regulated manufacturing area to provide and assist in the implementation of quality-related continuous improvement opportunities.
• Prepare and maintain all QMS documents (Training Matrices, Standard Operating Procedures (SOPs), Internal Audits, Customer Complaints, Management Reviews, etc.)
• Facilitate employee training on Quality Management System procedures, data confidentiality, and data protection.
• Plan, establish, coordinate, and follow-up on internal training courses related to the QMS (induction, procedural training, regulations) including and not limited to On-The-Job, QMS Online, etc.
• Preparation of training documents, materials, presentations, etc.
• Develop and maintenance of setup for global KPI reporting on quality metrics.

Additional Skills

• Strong attention to detail and problem-solving skills.
• Organizational and time management abilities, with the ability to prioritize tasks and meet deadlines.
• Strong analytical skills, with the ability to collect, analyze, and interpret data.
• Good verbal and written communication skills, with the ability to effectively communicate complex concepts and ideas.
• Knowledge of ISO 9001 quality management systems and regulatory requirements.
• Oversees the development and maintenance of processes, procedures, and other products associated with planning, project management, engineering, construction, safety, operations, acquisition, and other support functions.
• Develop and maintains quality management procedures including but not limited to internal and external auditing, corrective actions and opportunities for improvement, regulatory compliance, control of records, management review, and nonconformance processing in a QMS covering the full spectrum of Corps functions
• Assess and ensure all facilities quality assurance procedures and plans are compliant with regulations, regional QMS and ISO-9001 standards

Experience & Education:

• Degree in technical related field and 3 years of work experience in Quality or regulated industry
• Quality Management System experience (required)
• Minimum 2 years of experience in quality management (required)
• Comprehensive knowledge of Quality System and ISO 9001 standards and regulations
• Document control system operations
• Proficiency in Microsoft Office (required)
• GMP experience