Director Quality Assurance
MYKU Biosciences LLC is one of Colorado’s largest industrial Contract Manufacturers that is FDA registered with the following certifications : CDPHE ; cGMP; USDA Organic; & OTC.
MYKU Biosciences LLC is seeking an experienced quality assurance specialist to build our reputation with an unwavering commitment to meticulous production. The ideal candidate is an exceptionally organized, methodical professional with the experience necessary to take our products to the next level with respect to accuracy, security, and safety. You will be charged with upgrading our QA program that not only safeguards the quality of our products, but also fosters a “quality culture,” in which all employees become actively engaged in guaranteeing quality in both production and the finished product.
Objectives of this Role
· Interpret, build upon, and comply with company quality assurance standards
· Carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions
· Identifying & resolving workflow production issues
· Identifying production quality issues, causes, & corrective action. Document the process.
· Document quality assurance activities with internal reporting and audits
· Develop new standards for production and design, with improvements as needed, and create testing protocols for implementation across all service lines
· Identify training needs and take action to ensure company-wide compliance
Daily and Monthly Responsibilities
· Plan, execute, and oversee inspection and testing of incoming and outgoing product to confirm quality conformance to specifications and quality deliverables
· Oversee direction of product production quality supervisors
· Assist operations and local quality function in tracking, documenting, and reporting quality levels as well as CSR, environmental and health and safety goals/KPIs
· Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
· Develop or update company complaint and inspection procedures to ensure capture and investigation, as well as proper documentation of complaints
· Monitor risk-management procedures, and maintain and analyze problem logs to identify and report recurring issues to management and product development
· Provide training and support to quality assurance team on systems, policies, procedures, and core processes
· Develop/collaborate with key stakeholders’ actions plans and form recommendations for the Leadership Team on major quality and product safety issue as they arise. Prepare and present reports on quality data and trends.
· Develop and maintain tracking/trending reports to allow management to gain the appropriate visibility on product quality
· Ensure that all procedures and activities performed are GMP compliant
· Ensure deficiencies identified through internal or external audits are addressed in a timely manner
Skills and Qualifications
· Bachelor’s degree
· Professional certification, such as Six Sigma, Quality Engineer, or Quality Auditor
· Superb computer competence, including database management
· Knowledge of quality assurance terminology, methods, and tools
· Analytical, problem-solving, and decision-making skills
· Demonstrated knowledge of testing best practices, version control practices and defect management practices
· Understanding of Agile/Scrum methodology and how QA functions within it
· Strong attention to detail