Job Role Summary for Compliance Investigator This position will conduct root cause investigations, close deviations, support assignment of proper corrective actions, and facilitate implementation for Manufacturing under the direction of Compliance Management.
Will participate in the development and technical writing of documentation for the validation of equipment, calculation, data collection in support of QC lab site, global CI initiatives, and management reviews.
Lead completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned.
Ensure that the daily operations of assigned functional area are met through scheduling, troubleshooting and coaching.
Support and/or lead continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it’s, VIPs using Lean/DMAIC concepts and philosophy.
Assist Compliance Supervisor in leading daily operations.
Participate in test plans, protocols, and reporting documentation for the validation of equipment.
Perform review of test data with application of GDP.
Use Global LIMS or other computerized systems for entering, approving, and trending test results.
May be required to conduct investigations and/or audits into Alert/OOL excursions.
Actively contribute to a team setting at the Los Angeles Manufacturing Facility and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.
Provide training and work direction for assigned functional areas.
Investigate deviations and write exception documents as required, utilizing problem-solving tools as needed.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
May be required to generate, execute, and/or summarize studies and/or review/revise of SOPs.
Complete and/or direct completion of special project/protocol testing in a timely manner.
Assist Compliance Supervisor in updating department metrics and report shift activities, as assigned.
Ensure personal training requirements are met and that training records are current.
May perform disposal of hazardous waste.
Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.
Lead and/or facilitate problem solving events.
Lead the investigation closure of manufacturing compliance related documents.
Using quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.
Represent the departments during the product release process, compliance, and Continuous Improvement projects and audits.
Participate in deviation related meetings and provide feedback, leadership, and support to manufacturing supervisors, trainers and manufacturing technicians on the status of compliance of the department.
Conduct mediations to ensure timely release of product for customers.
Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to cGMPs and EHS regulations.
Identify and implement Value Improvement Projects (VIP) to drive success in the areas of compliance, cost effectiveness, and product lead time.
Participate in regulatory and non-regulatory audits.
Lead investigation and provide comprehensive investigation write up and/or presentations.
100% Onsite Position Requirements Writing Sample must be provided with Resume Education: A Bachelor’s degree in chemistry, biological science, or other related technical field.
2 years of related experience.
Experiences:
• Effective organizational skills and ability to plan and suggest resolutions to technical problems.
• Must be detail-oriented, conscientious, responsible and able to multiple task.
• Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
• Demonstrate interpersonal skills with the ability to interface and influence with personnel of all levels.
• Ability to analyze and interpret scientific and statistical data.
• Experienced understanding of cGMP and other regulatory guidelines applicable to the medical/bio-tech industry.
• Working knowledge of Quality Systems, Trackwise, and working experience with Microsoft Office applications.
Job Requirements: Perform privacy compliance audits/reviews Manage the local compliance committee in coordination with the regional compliance officer Manage compliance and regulatory programs Perform ongoing privacy compliance monitoring activities Revise compliance and privacy policies and procedures Developing company’s legal and regulatory compliance program Perform ongoing risk assessments and compliance reviews to ensure compliance policies and risk controls Spend policies and procedures for compliance Complete all required compliance training Ensuring regulatory compliance with all policies and goals Oversee the trade compliance training program Support all compliance-monitoring programs to ensure compliance with federal and state laws and the adequacy of internal compliance processes Maintain compliance with all laws and applicable regulatory requirements Overseeing compliance with applicable state laws and regulations Providing training to employees on regulatory and compliance issues Conduct regulatory and compliance research Ensure compliance with specific privacy requirements Provide compliance support for internal policies and procedures Resolve investment advisory compliance issues Oversee compliance activities related to ERISA Ensure compliance with various aspects of the organization’s privacy and security compliance program