JOB SUMMARY:

The Quality Specialist II works closely with Quality Management and various departments to ensure quality and regulatory documents are accurate and up to date. Employee(s) in this role focus on the administrative tasks related to GMP compliance, auditing, document control, document retention, and quality management system maintenance. This includes, but is not limited to:

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES:

• Knowledge of GMP requirements pertaining to manufacturing, personal care, and OTC drug industry is required.
• Experience with document control specifically related to manufacturing quality documents, specifications, and SOPs required.
• Must be able to work independently and effectively with a high level of accuracy with good attention to detail.
• Possess good organization and prioritization skills.
• Able to communicate effectively in writing and verbally in the English language.
• Must have knowledge of how to operate and use a computer.
• ERP Systems (experience preferred)
• Microsoft Suite (Teams, Word, Excel, PowerPoint)
• Internet applications
• Other applications a plus (LIMS, World-Over, Asana)
• Capable of performing mathematical calculations and verifying accuracy of calculations by others.
• Good communication skills are required. Ability to communicate deviations and other information effectively and professionally with peers and outside parties.
• Perform essential duties and responsibilities efficiently, accurately, and safely.

EDUCATION/EXPERIENCE:

• Associate degree minimum, Bachelor’s (BS or BA) degree or higher preferred.
• May substitute experience for education pending candidate qualifications.
• Minimum of 3-5+ years of document control, quality assurance, or quality control experience.
• 3-5 years’ experience working in manufacturing environment is preferred.

• Review, filing, and control of GMP controlled documentation including batch records, cleaning and maintenance logs, logbooks, testing records, raw material records, finished good retain records, and environmental control records, etc.
• Product release of bulk and finished goods for Cosmetic, Personal Care, OTC, and Medical Device.
• Generate and review bulk batch and process validation protocols and reports and provide support to Quality Engineering and Validation Program.
• Adhere to document control, regulatory practices and policies, and customer requirements.
• Conduct SOP reviews and assist with creation of new SOPs and other documents
• Assists with the management of sample retain program.
• Generation of GMP and other quality reports for tracking/trending.
• Conduct review and processing of change control procedures and documentation.
• Participate in non-conformance, CAPA, customer complaint, and other Quality activities.
• Assist with internal audit program and audit activities.
• Maintenance and control of personnel training files and conduct employee training as directed.
• Communicate with internal and external customers.
• Oversees relationship with contract laboratories including communications, requests, handling of results, error correction, etc.
• BOM Routing reviews and signoff.
• Support quality in enforcement of ISO 22716, ISO 13485, 21 CFR 210/211 requirements.
• Participate in RCA, Kaizen, and other investigational process improvement activities.
• Provide quality support as needed to the QA, QC, and Regulatory department.
• Other duties as assigned.