Quality Manager will be responsible for striving to proactively drive the corporate quality culture and promote cGMP activities.
Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements.
Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers.
Maintains product specifications, HACCP plans, and other controlled documentation.
Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements.
Performs internal audits and supplier audits as required.
Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions.
Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required.
Provides GMP and GDP training to site personnelWorks with all departments to investigate and resolve process and product quality issues.
Performs other duties as assigned with or without accommodation.
Minimum of Bachelor's degree required; focused degree in Engineering, Scientific, Technical Scientific, or Quality Regulatory Compliance disciplines preferred.
Minimum of at least 5 years in pharmaceutical or dietary supplement industry with experience in quality assurance/quality control management role.
Proficient knowledge and application of cGMP regulations, specifically FDA 21 CFR Part 110, 111 and 117.
Experience in technical writing – SOP’s, non-conformances, etc.
Six Sigma, Lean, 5S or ASQ Certification or trainings preferred.
Demonstrated excellent time management and organization skills to handle multiple projects and deadlines required.
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