Quality Assurance Supervisor

 Quality Assurance Supervisor

 Full-service beauty manufacturer is seeking a Quality Assurance Supervisor to join their team.  This full-time position will provide management of Compliance activities for the site following company policies, standards, procedures, and cGMPs.  This will include USA & Canadian regulatory compliance to the FDA and Health Canada regulations. The job includes organization and maintaining documentation.

Key Responsibilities:

• Supervises and manages the activities of the Quality Compliance group. Assures job objectives are met on a timely basis.
• Leads team members in the deviation investigation process.
• Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Ensures control of systems, processes, and products through supporting review and approval of change notices and change control.
• Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed promptly.
• Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (ISO 22716, 21 CFR Parts 210 and 211).
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc.
• Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.
• Collecting, collating and evaluating scientific data that has been researched by colleagues and providing strategic advice to senior management.
• Project managing teams of colleagues involved with the development of new processes and procedures.
• Reviewing company practices and providing advice on changes to systems.
• Provides administrative support by implementing systems, procedures, and policies; completing projects in support of compliance auditors.
• Complies with federal, state, and local legal requirements by studying existing and new legislation; enforcing adherence to requirements; advising management on needed actions.
• Collaborates with other departments to direct compliance issues to appropriate existing channels for investigation and resolution.
• Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations.
• Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated, and resolved.
• Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
• Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future.
• Provides reports regularly, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts.
• Responsible for assisting with developing, reviewing, and executing validations to maintain Compliance with FDA and CGMP regulations.
• Performs additional assignments and responsibilities as determined by Vice President of Quality.

 Requirements

• Must have a Bachelor’s Degree in Chemistry, Biology, Environmental Sciences, or related field of study.
• Minimum 5 years related management experience.
• Must have GMP, Quality, and in-depth risk management knowledge.
• Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management with clarity and accuracy.
• Must have strong authorship and be able to critically review investigations with Quality risk management principles.
• Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision making and building relationships.
• Manages positive relationships with external customers.
• Bilingual in English & Spanish is preferred.

For immediate consideration and to discuss in greater detail please send resume outlining your related experience.  Pay range for this opportunity is $70k – 90k/yr.