Performs regulatory analysis to monitor state and federal
regulations and support complex business operations to ensure compliance.
Responsible for the accurate completion and submittal of process filing
applications with governmental agencies and acts as a liaison during on-site
audits and inspections.
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a detailed and accurate review of the process and temperature charts and
other monitoring data daily to ensure compliance with Federal and State
detailed support for the FDA Food Safety Modernization Act (FSMA),
program compliance and support.
all process and aseptic control documents to ensure HACCP and FSMA
a clear and detailed action plan for any process deviations.
and submit any required process variation report and affidavits in
compliance with Federal and/or State regulations.
physical/visual inspections of process operations to identify areas that
have the potential to create a microbiological contamination risk.
Develop detailed action plans for high risk areas to include
micro-organism growth mitigation matrices for applicable risk areas.
in-depth analysis and interpretation of regulatory compliance
requirements against the companyís current operating control standards
employee training to include SOPís, QA, Food Safety Training for newly
hired employees, refresher and annual employee
a daily detailed inspection and analysis for any
microbiological-positive test results to efficiently identify affected
process systems or associated mechanical components. Monitor test
results for trends and report them to management.
concert with plant management team, provide technical support to review
proposed regulatory compliance activities to determine the potential
impact on company operations.
for the management of the companyís process control records, including
the organization, storage and recordkeeping
management in accordance with company, state and federal legal
requirements for compliance record retention.