The Quality Assurance (QA) Associate is responsible for performing QA inspections on the manufacturing floor during production processes. The role involves assisting in maintaining an effective quality system across relevant areas, ensuring that purchased and manufactured materials consistently meet design, QA, manufacturing, and regulatory requirements. The QA Associate will also support handling quality events such as customer complaints, CAPAs, SCARs, and non-conformances while adhering to proper documentation practices to ensure compliance with FDA, ISO, and other applicable regulatory standards.

Duties and Responsibilities

• Conduct hourly inspections as outlined in the production operation SOP.
• Accurately complete and maintain inspection records, ensuring they are clear, complete, and precise.
• Perform packaging inspections for each batch in accordance with finished product packaging quality standards and inspection SOPs.
• Ensure inspection records are accurate, clear, and complete.
• Perform sampling and sample retention for each batch according to the sampling form. 

Additional Responsibilities

• The QA Associate may also be required to perform other tasks as assigned by the QA Manager, including but not limited to:
• Conduct inspections of incoming raw materials to ensure they meet quality standards.
• Verify that submitted documentation complies with internal quality requirements.
• Assist in reviewing batch records for accuracy and completeness.
• Review inspection paperwork to ensure adherence to compliance standards.
• Provide training and technical expertise to team members as needed.
• Support the upkeep of equipment calibration and temperature logs.
• Maintain accurate documentation for incoming and outgoing products.
• Ensure a safe work environment in alignment with local, state, and federal regulations.

• Collaborate with cross-functional teams to organize, store, and archive documents effectively.

Qualifications

• Education:
• High school diploma required; a bachelor's degree is preferred.
• Skills and Competencies:
• Ability to work effectively with a cross-functional team in an international environment.
• Strong written and verbal communication skills in English.
• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and spreadsheets.
• Strong analytical, problem-solving, and troubleshooting abilities
• Excellent prioritization and time management skills to handle multiple tasks efficiently. Self-motivated and proactive, with a proven ability to take initiative in daily responsibilities.
• Preferred Qualifications:
• Bilingual proficiency in Chinese or Spanish (spoken and written).