Quality Assurance Specialist

Responsibilities

• Provide QA support for daily manufacturing operations in accordance with approved SOPs and cGxP requirements.
• Aid in reviewing executed batch records, logbooks, and production documentation for accuracy, completeness, and cGMP compliance.
• Support deviation initiation and investigation activities, including documentation, root cause analysis, and timely closure.
• Afford material release assistance.
• Perform routine QA walkthroughs on the manufacturing floor and escalate quality events per established procedures.
• Assist with document control activities, including the review and routing of SOPs.
• Support change control processes for operational and documentation changes.
• Support quality oversight of product status, including shipping documentation and release readiness.
• Identify and help correct non-compliance with cGMP and GDP requirements.
• Perform other QA-related duties as assigned to support operational needs.

Requirements

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc.)
• 1-5 years of experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc.)
• Basic understanding of cGMP principles and regulatory requirements (FDA, EMA, ICH).
• Familiarity with quality management systems and GDP practices in a GMP facility.
• Excellent communication, organizational, and analytical skills in a fast-paced, dynamic environment.
• Ability to work both independently and collaboratively with cross-functional teams.
• Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset.