QA Compliance Supervisor

The Quality Assurance Compliance Supervisor is responsible for supervising and coordinating the activities of the Quality Assurance team engaged in the regulatory compliance related to Quality Assurance of the organization. Additional duties include staff selection, training, performance coaching, and professional development.

Requirements

• MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS
• Associates degree or equivalent experience commensurate to the industry
• Must possess good computer skills to be proficient in Microsoft office
• Be able to learn, use and train on in-house computer programs (PCLE)
• Experience in cGMPs in a regulated industry
• Experience with CAPA, deviations, and customer complaints preferred
• Detail-oriented, with developed analytical skills and strong problem-solving skills
• Strong written and verbal communication skills to include the ability to be effective in working with production operators, supervisors and management
• Must be able to work overtime or on weekends as needed
• OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
• Oversee the QA assessment of customer complaints utilizing risk scoring methodology.
• Administer the organization’s deviation process.
• Assign tasks and delegate activities related to the internal investigation processes.
• Conduct / lead root cause investigations related to nonconformances, deviations, CAPA, SCAR, and customer complaints
• Review and update SOPs related to job responsibilities
• Ensure deviation, CAPA, and customer complaint assessments and investigations are addressed and completed in a timely manner
• Assist in the material review board meeting and weekly QA meetings to develop, train and communicate the status of ongoing investigations
• Trend, monitor, and report KPIs associated with nonconformances, deviations, CAPA, SCAR, and customer complaints.
• Assist with cGMP internal audits, write, and respond to internal audit reports
• Train QA specialists supporting this role.
• Assist with supplier qualification and approved supplier process
• Direct supervision of inspection, investigation, and review processes and QA Specialists
• · Review Change Control documentation for specification consistency
• · Assist in the label review process
• Perform other duties and responsibilities, as assigned
• WORK ENVIRONMENT
• Duties are performed primarily in a smoke-free office and production environment
• PHYSICAL REQUIREMENTS
• Frequent sitting, standing, walking, and climbing
• Able to lift up to 25 lbs.