Coordinate complaint investigation requests with contract manufacturers; review/approve complaint investigation reports. Engage in problem-solving and day-to-day decision-making associated with product batch release, validation and deviations.
Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including process validation reports, manufacturing technical documents, stability reports and process flow diagrams.
Ensure that the quality of all products shipped comply with customer specifications and company quality standards. Effectively partner with regulatory agencies, consultants and contractor personnel, ensuring other company personnel cooperate in implementing regulatory requirements.
Responsible for attending any required training and following all procedures/processes/policies within BSI for management of clients, management of a home based office, use of BSI equipment and communication both internal and external to the organization.
Quality Assurance Supervisor is responsible for the management, design, planning, execution, and reporting of all activities required to verify conformance to defined Company and Government criteria. Design, develop and implement Quality Control training programs.