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 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.

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