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JOB SUMMARY
The Regulatory Quality Assurance Auditor is responsible for supporting the implementation and maintenance of Santa Cruz Nutritionals’ Quality Assurance system in all facets, ensuring compliance to internal, customer and regulatory audits per 21CFR111 and 21CFR117 and FSMA.
ESSENTIAL DUTIES
o Conducts independent internal audits (GMP and FSMA) of all production, product storage, and laboratory areas.
o Participates in process management and improvement initiatives.
o Ensures documentation complies with 21CFR111 and 21CFR117 standards and best practices, and provides staff with input and feedback regarding revisions.
o Develops and oversees the performance of regulatory programs specific to FSMA, Food Defense, FSVP and Crisis Management.
o Conducts assessments and evaluates through analysis and interpretation of objective and subjective evidence to verify compliance to standards and applicable quality plans (listed above). Develops written reports of findings and escalates unresolved issues to appropriate management levels.
o Evaluates internal audit observations to assess findings and researches solutions to identified observations. Makes verbal and written recommendations to appropriate parties and helps to implement solutions.
o Participates in special projects, internal/external audits and process improvements in support of quality assurance initiatives. Leads various initiatives.
o Coordinates the definition and maintenance of effective and efficient quality programs, including the development and presentation of associated training and familiarization to affected staff. Revises standard practices and procedures as appropriate.
o Provides leadership and work guidance to less experienced personnel.
MINIMUM REQUIREMENTS
B.S. Biology, Chemistry, Engineering or other relevant discipline.
5+ years industry experience (QA)
