Job Description

A Quality Assurance Specialist II typically ensures that products, services, or processes meet established quality standards through testing, analysis, and compliance monitoring. Below is a general job description for this role, which can be tailored to a specific industry (e.g., manufacturing, software, healthcare, etc.) if needed. Let me know if you want it customized for a particular field!Job Title: Quality Assurance Specialist IIJob Summary:The Quality Assurance Specialist II is responsible for implementing and maintaining quality assurance processes to ensure products, services, or systems meet organizational and regulatory standards. This intermediate-level role involves conducting detailed inspections, testing, data analysis, and documentation, while collaborating with cross-functional teams to identify and resolve quality issues. The role requires a strong understanding of quality control methodologies and the ability to contribute to process improvements.Key Responsibilities:Perform detailed testing and inspections of products, services, or systems to ensure compliance with quality standards, specifications, and regulations.Analyze data and generate reports to identify trends, defects, or non-conformance issues.Develop, review, and update quality assurance protocols, procedures, and documentation.Collaborate with production, engineering, or development teams to address quality issues and implement corrective actions.Conduct audits of processes or systems to ensure adherence to internal policies and external regulations (e.g., ISO, FDA, etc.).Assist in root cause analysis and recommend solutions to prevent recurrence of quality issues.Train junior staff or team members on quality standards and procedures.Support continuous improvement initiatives to enhance product quality and operational efficiency.Maintain accurate records of quality tests, audits, and corrective actions for compliance and reporting purposes.Basic Qualifications:Bachelor's degree & 2 years' directly related experience.Preferred Qualifications:Bachelor's degree in biology, chemistry, or related science and minimum 3 years' experience performing quality assurance functions in pharmaceutical and/or biotech related fields.Experience in aseptic manufacturing processes.Knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents.Proficient with commonly used word processing, database systems and other software.Ability to work with all levels cross-functionally.Ability to independently analyze and reconcile simple issues.Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.Good interpersonal, verbal, and written communication skills.Specific vision abilities required by this job may include passing a vision test in order to perform statistical inspections of drug product.Good attention to detail.

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