Los Angeles, CA, USA
198 days ago
Quality Assurance Specialist (Medical Device/Pharmaceutical)

Work Location: Los Angeles, CA/ Onsite

Job Description

● Assist the department lead to ensure the Quality Management Systems and regulatory compliance requirements are effectively maintained, implemented and monitored

● Provide continuous assessment of the Quality Management System including CAPA, internal audit and other related processes to ensure compliance requirements.

● Identify gaps, enhancements and create/establish process checklists/forms, work instructions, non-conformance reports and ensure all quality check procedures are put inplace.

● Directly responsible for CAPA Reporting management and oversee complaint handling activities, recordkeeping and maintenance

● Initiate Nonconforming Material Reports and determine impact of nonconformances. Provides technical input for determining final disposition

● Assist with corrective actions, process investigations and implementation activities

● Conduct a variety of incoming and/or final inspections on inbound materials from vendors and outbound products for shipping

● Provide support for both internal and external audit activities as necessary

● Assist in preparing periodic quality metrics reports to determine product quality and performance

● Coordinate and provide employee training timely and maintain training records for documentation

● Any additional responsibilities, duties as directed by Management up to including any regulatory activities, if applicable

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