Hillview Consulting Solutions · 17 hours ago
Quality Management Specialist (GMP/ CAPA/ Validation)
Lewisville, TX
Contract
Onsite
Mid Level
$40/hr - $44/hr
3+ years expHillview Consulting Solutions is seeking a Quality Management Specialist to serve as a technical expert for compliance quality issues. This role involves managing quality systems, conducting internal audits, and performing root cause analysis to ensure product quality and regulatory compliance.
Staffing & Recruiting
Responsibilities
Quality Management System (QMS) – responsible for duties relating to Quality Systems including but not limited to batch record review, document control, change control, annual OTC product review, validation support, stability support, review of quality events, and investigation of market quality events. Assist with approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices. Supports additional special projects related to these objectives as required
Inspection Readiness - Must remain knowledgeable about significant global regulatory changes that could impact products. Assists with the implementation and monitoring of related systems, policies, and procedures. Supports efforts to ensure proper compliance quality management systems are maintained and that the global Quality standards are met and consistently followed. This support includes conducting internal system audits. manufacturing centers as well as International Subsidiaries. Provides support for audits by external agencies (FDA, TDH, Health Canada, etc.)
Root Cause Analysis – Performs and advises on root cause analysis for product quality issues and works issue through containment phase of corrective action process. Supports investigation of internal and external failures to determine cause. Partners with various departments (including Quality, R&D, Manufacturing Operations, Purchasing, Package Engineering, and Legal) to request input to aid in feedback investigation, root cause identification, and implementation of actions to respond to both immediate issue resolution and long-term systemic resolution and prevention of recurrence. Follows up to verify that changes in the systems are implemented and monitors the systems over time to verify effectiveness
Internal Auditor - serves as internal auditor ensures that the site is operating in state of compliance. This includes developing audit plans and performing audits while meeting timeline objectives as well as documenting/ reporting audit results including corrective action plans when applicable. Collaborates with management staff to support the needs of manufacturing while maintaining the quality standards and with other internal departments to ensure compliance with policies. Regularly assesses processes to determine if requirements are being met
Qualification
Required
investigations root cause analysis or corrective actions - Critical
Experience computer system validation - Critical
Experience: 3+ years
Field of Experience: quality assurance or quality control
Education: Bachelor/University Degree
Education Focus: Chemistry, Microbiologoy
Must have a good understanding of advanced quality principles, of audit protocol, inspection procedures and FDA and cGMP regulations
Must be familiar with compliance requirements for over the counter (OTC) products
Ability to apply advanced principles, theories, and concepts and contribute to the development of new principles, systems and concepts
Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity
Must have sound and comprehensive oral and written communication skills to interact with various levels of personnel from different cultures both within and outside the company
Must be able to perform duties under very general direction and independently perform assignments with only general criteria for expected results
Preferred
Annual product review - Would be nice
Experience with validation, process, cleaning or equipment validation - Would be nice
Any experience around any type of stability program - Would be Nice
Certified Quality Auditor
Certified Quality Engineer
Certified Quality Manager
Company
Hillview Consulting Solutions
Hillview Consulting Solutions is well-versed in a variety of technology stacks and with a team of experienced individuals, our aim is to assist customers in scaling their IT and engineering teams.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase