The Quality Assurance Specialist is responsible for overseeing all quality-related tasks and operations within the organization. This role requires a strong understanding and application of Quality principles, practices, and procedures. Key responsibilities include supporting the change control process, CAPA system, deviation process, nonconforming material process, customer complaints, supplier approval, material receiving, internal audit process, and document control. Candidates should have experience in ISO-9001/ISO 13485 or cGMP manufacturing environments and a demonstrated familiarity with standard quality concepts.
Responsibilities:
Lead quality-related decision-making processes.
Ensure thorough review of batch records prior to material release, ensuring accuracy and completeness.
Conduct root cause analyses and develop robust corrective and preventive actions for internal non-conformances and customer complaints.
Evaluate incoming materials against internal procedures and approve materials for release.
Review technical documents and reports to identify errors and potential non-compliance issues.
Complete supplier approval documentation for new suppliers.
Participate in planning, executing, and following up on internal audits and inspections.
Assist in tracking and maintaining document control activities.
Draft, revise, and review standard operating procedures (SOPs) and custom specifications.
Maintain a comprehensive understanding of applicable SOPs.
Perform other duties as assigned.
Qualifications:
Bachelor's degree in a quality/compliance-related field or science-related field, with 2-4 years of relevant experience.
Strong attention to detail.
Ability to work independently with minimal supervision.
Proficient in Windows-based computer skills, including Microsoft Word and Excel.
Excellent organizational skills with the ability to manage multiple priorities.