Quality assurance specialist job description

Quality assurance specialist job description

This article include content: job purpose, key duties/responsibilities and related documents of Quality assurance specialist.

Job purpose of Quality assurance specialist

To Support technical relationship with customers and Co-manufacturing sites on existing products. Works directly with customers (and sales, customer service) and internal resources in obtaining requested information, problem resolution, and identifying opportunities for improvement.

Key duties/responsibilities of Quality assurance specialist:

• Performs internal supplemental audits of a technical discipline to verify that facility records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory requirements.
• Ensures systems used in QA are properly maintained (e.g., QA audit records, training records).
• Performs protocol, data, report, and in-lab phase inspections in a technical discipline to verify conformance to applicable SOP and regulatory requirements.
• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution.
• Notifies management of quality/compliance trends and service failures.
• Monitor regulatory and industry trends/actions and report regularly to QA management.
• Research and write white papers providing recommendations for QA management.
• Facilitates changes to SOPs, policies, training materials, and other documents for a technical discipline.
• Mentors co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.
• Assists and/or hosts during regulatory inspections.
• Provide supervisor support on selected, large-scope projects involving data collection and / or research small scope individual topics drafting recommendations to QA management.
• Develops and implement appropriate verification programs and systems at co-manufacturing sites.
• Interfaces with Co-manufacturing QA/QC/Mfg and Sales or Customer Service (or other groups) in problem resolution, and continual improvement.
• Provides advanced assistance to host by establishing client contact.
• Performs gap analysis of quality and analyzes monthly trending reports of key quality indicators for co-manufacturing sites to ensure continuous quality improvement.
• Recommends and implements modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
• Responds to customer complaints, inquiries and audit requirements relating to Co-manufacturing sites with appropriate sense of urgency and business criticality.
• Support product quality/ co-manufacturing failure investigations, define investigational strategy.
• Evaluates new co-packers prior to site selection and works with selected sites to ensure timely implementation and effectiveness of corrective actions.
• Build appraisal system and appraise staff (include performance appraisal samples).

Related quality assurance documents:

Quality assurance specialist job specification
• All samples of Quality assurance job description
Quality interview questions
Quality assurance manager job description
Quality engineer job description
Quality analyst job description
Quality manager job description
• Other sources: QA manager job description

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