Quality Assurance Technician

Quality Assurance Specialist

Requirement/Must Have:

• Basic computer skills including Microsoft Outlook, Word, and Excel.
• Ability to work in a controlled manufacturing environment with required PPE (hairnet, safety glasses, safety shoes, smock, etc.).
• Ability to stand and walk for extended periods and perform physical tasks on the production floor.
• Ability to detect visual defects such as surface irregularities, color variations, and dimensional inconsistencies.
• Strong attention to detail and good communication skills.

Experience:

• Previous Quality Assurance experience preferred.
• Experience in the medical device or pharmaceutical industry preferred.
• Experience supporting production environments and quality inspections.
• Experience with documentation related to nonconformance events preferred.

Responsibilities:

• Support production by responding to nonconformance events and assisting with containment of affected products.
• Assign nonconformance tracking numbers and guide proper documentation of quality events.
• Perform spot checks on the production floor to ensure procedures and quality standards are followed.
• Monitor inspection processes and ensure adherence to SOPs and work instructions.
• Conduct daily audits of production areas and documentation to maintain GMP compliance.
• Maintain accurate documentation of inspections, audits, and quality-related activities.
• Assist departments with containment and segregation of nonconforming materials.
• Confirm defects found in production and assist with root cause investigations.
• Support corrective action implementation and continuous improvement initiatives.
• Collaborate with operations and engineering teams to resolve quality issues.
• Assist in preparation for internal and external audits.
• Provide training and feedback to operations staff on quality procedures and standards.
• Promote a culture of quality, safety, and compliance across teams.
• Ensure compliance with safety regulations and company policies.
• Perform additional duties as assigned.

Should Have:

• Familiarity with SAP systems preferred.
• Knowledge of GMP practices and manufacturing quality processes.
• Strong analytical and problem-solving skills.
• Ability to collaborate with cross-functional teams.

Skills:

• Quality Assurance and Inspection.
• GMP Compliance.
• Documentation and Audit Support.
• Nonconformance Management.
• Root Cause Analysis.
• Microsoft Office (Outlook, Word, Excel).
• SAP (Preferred).

Qualification and Education:

• High school diploma or equivalent required.
• Additional training or certification in quality or manufacturing processes preferred.

Work Environment:

• Work will be performed in a cleanroom, laboratory, and manufacturing environment.
• Frequent standing, walking, bending, and physical activity required.
• Exposure to mechanical equipment, moderate to loud noise, and occasional chemicals or airborne particles.
• Must wear required PPE including safety glasses, hearing protection, safety shoes, smock, hairnet, and beard cover when applicable.