Quality Assurance Specialist and Auditor

Quality Assurance Specialist and AuditorBackgroundSpectrum Chemical Mfg. Corp, founded in 1971 as a fine chemical manufacturing company, is one of the chemical industry's leading customer-focused global suppliers of high-quality chemicals, laboratory supplies, and equipment. Spectrum Chemical Mfg. Corp facilities are registered with the US Food and Drug Administration as a drug establishment, operate under current Good Manufacturing Practices, and are ISO 9001:2015 certified.The Quality Assurance Specialist and Auditor performs various activities across the Quality System to ensure compliance with applicable regulatory requirements and standards to maintain compliant processes and our products' high quality, safety, and purity.ResponsibilitiesCustomer and External AuditsLead, host, and coordinate virtual or on-site customer audits to present overall quality systems, procedures, and objective evidence.Provide formal audit responses to Customers as required.Support, as assigned, regulatory and certification audits.Maintain an audit-ready book to ensure routinely requested documentation is current and readily available for planned and unannounced audits and inspections.Complete customer quality system questionnaires, surveys, and other inquiries related to the Quality SystemInternal and Supplier AuditsLead and conduct internal audits as assigned to ensure compliance with ICH Q7, 21 CFR Part 211, 21 CFR Part 111, ISO 9001:2015, and other applicable regulations and standards.Support the Internal and Supplier audit program to ensure audits are planned, executed, and documented per ISO 9011:2018.Track, and support the timely execution and documentation of appropriate investigations, corrections, corrective actions, and risk assessments for audit and inspection observations or nonconformances.Conduct process audits, 5S, and Gemba Walks as assigned. Conduct supplier audits as a member of the audit team or Lead Auditor as assigned. Conduct verification checks of corrective actions identified in audit responses, CAPAs, complaint responses, and other sources as assigned.Audit ReadinessConduct companywide training to support audit readiness.Conduct cGMP, Good Documentation, and ISO training at the assigned intervals.Support the training of new employees in the Quality System.Support additional project team activities and investigations and participate in process improvement activities and projects. Participate in developing and maintaining policies, procedures, work instructions, and other documents.Track and trend observations from both external and internal audits.GeneralSkills & Qualifications Bachelor's degree or equivalent experience required.ISO 9001:2015 Lead Auditor or ASQ Certified Quality Auditor certification is a plus, though not required.One (1) to three (3) years of relevant Quality Management System experience in an FDA-regulated and ISO-certified environment is required.Demonstrated working knowledge of ISO 9001:2015, 21 CFR Part 211, and ICH Q7 preferred, knowledge of 21 CFR Part 820, ISO 13485:2016, or other related standards and regulations accepted. Experience working in an e-QMS and ERP system.A good understanding of cGMP and Good Documentation Practices is required.Ability to work closely with internal and external personnel to increase compliance and cooperation while creating opportunities to improve operations and implement effective solutions to reduce errors.Ability to interpret various regulations and standards and communicate requirements to the appropriate individuals.They are highly organized and pay strong attention to detail.Strong Microsoft Office Skills (Word, Excel, PowerPoint).Strong written and oral communication skills.TravelDomestic and international travel may be required to conduct audits. Schedule Varied shifts depending on the schedule of inspections and audits. It may require additional hours to support business needs. Monday - Friday: 8:00 am - 5:00 pmMonday - Friday: 7:00 am - 4:00 pm Monday - Friday: 9:00 am - 6:00 pm

Created: 2024-11-09