Job Title: Quality Systems Specialist

Job Description

The Quality Systems Specialist is responsible for providing support and continuous improvement to the Quality System. The role involves ensuring compliance with internal audits, GMP standards, regulatory and customer requirements, sanitation, pest control, nonconformance investigations, CAPA, customer complaints, change control, and managing HACCP & PCQI certifications. The position requires excellent verbal and written communication skills to compile and present data and trends for Quarterly Management Review, Annual Product Review, and Annual Management Review.

Responsibilities

• Manage regulatory inspections, customer, and third-party audits by presenting documents and answering auditor’s questions.
• Schedule and coordinate audits, acting as the point of contact.
• Ensure corrective actions are completed and respond to audit findings.
• Maintain audit files and manage GMP audit programs at the manufacturing site and WI warehouses.
• Represent Quality in QA/Ops Gemba audits and schedule audits with area leaders.
• Photograph and report findings, and assign Audit Work Orders as needed.
• Manage CAPA programs, ensuring CAPAs are effective and closed timely.
• Oversee site QAM initiatives and manage HACCP and Food Safety programs, ensuring compliance with food safety requirements.
• Interact with customers and customer portals for audits, corrective actions, and customer satisfaction.
• Manage Internal Audit programs and present quarterly Internal Audit Reports.
• Coordinate with Production and other departments to discuss, resolve, and eliminate documentation observations.
• Provide guidance to Document Coordinators to process Procedures and Work Instructions.
• Identify, lead or manage quality system document improvements focusing on effectiveness, efficiency, and simplification.
• Drive continuous improvement initiatives as site representative for Docushare, Agile, and other systems.
• Plan, prioritize, and work under pressure to meet deadlines with good follow-up and documentation skills.
• Organize, direct, and manage teams in a problem-solving environment.
• Determine severity of quality issues with QA/QS Manager and properly interpret regulatory standards.
• Maintain open communication with all departments to assist with arising issues.

Essential Skills

• Expertise in quality systems and quality assurance.
• Experience in pharmaceutical and medical device industries.
• Proficiency in GMP and cGMP standards.
• Knowledge of 21 CFR 820, ISO, and BRC standards.
• Ability to work with DocuShare, Documentum, and secured documents.
• Skill in using pivot tables and audit trails.

Additional Skills & Qualifications

• Bachelor's degree in the Sciences.
• Five years of GMP, cGMP experience within food manufacturing.
• Three years of experience with food safety audits.
• PCQI Certification is a plus.

Work Environment

The role is based in an office within a wet wipe (OTC and Med Device) and coffee filter manufacturing facility.