Compliance Coordinator

Compliance Coordinator Responsibilities

Essential Duties and Responsibilities, including but not limited to following:

GMP is a controlled environments where stringent rules and procedures must be followed to prevent contamination. These are critical areas of manufacturing/research facilities using specialized equipment and systematic cleaning processes, keeping all airborne particulates, contaminants, and pollutants kept within strict limits.

o Build and develop relationships with onsite POCs to identify risks, solve problems, improve processes, and achieve goals.

o Interpret regulatory rules and assist in the implementation of policies and procedures to ensure compliance for all staff.

o Assist with audits and investigations, and report on suspected non-compliance.

o Analyzes internal opportunities for improvement.

o Create Site inspections, SWOPs, and reports to meet ABM standards.

o Schedule and follow up on all monthly inspections with supervisors.

o Establish and maintain a customer satisfaction follow up and call back procedure and provide senior management with appropriate feedback.

o Ensure all staff is in compliance, using reports from ComplianceWire or other client-based programs.

o Monitor SOP changes and update the team and management on any changes relevant to our procedures.

o Implement SOPs onto production floor, collaborating with Supervisors and colleagues to meet strict deadlines.

o Help support day-to-day activities including email support and delegating tasks to employees as needed.

o Must be able to determine the best process to use for each job and define the tooling and fixtures required to execute.

o Daily documentation review of logbooks of all facilities.

o Order and maintain logbook demand for each facility including Routine and Non-Routine.

o Conduct required training sessions as needed including GMP and ABM trainings.

o Create and maintain employee training records files to be always in an audit ready state.

o Serve on GMP floor to gain knowledge on proper procedure of production within our BioMarin facilities, including but not limited to: Cleaning, Stock Gowning, Mixing of Solutions.

o Adhere to the cleaning process and be able to train staff to perform the job.

o Create and provide trainings to staff as needed.

o Expect to work different schedules, including weekends and holidays to meet site and staff needs.

o Able to work routine/non-routine cleans as needed to support staff and supervisors.

o Ensure equipment is being meticulously cleaned and maintained.

o Perform other duties and responsibilities as requested or required.

o Regularly review the work of employees to identify compliance issues and provide on-going guidance and training as needed.

o Provides feedback to Manager regarding inquiries and frequently asked questions received from staff to better inform and improve policies, procedures, training materials, etc.

o Track metrics/KPIs, as well as audit findings to assist departmental management in identifying opportunities for process improvement and performance management.

o Coordinate with supervisor, manager, and staff to prepare for training in ComplianceWire and or on the field.

Mon-Fri (8am-4:30pm)