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 II
Job 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.