Job Description

Position Summary:

We are seeking a detail-oriented and experienced Quality Assurance (QA) Specialist to support and drive quality initiatives across our operations. This individual will play a key role in ensuring compliance with internal quality standards and applicable regulatory requirements (e.g., FDA, ISO, GLP). The ideal candidate brings a strong background in quality systems, document control, audits, and continuous improvement within a Biotechnology environment.

Key Responsibilities:

• Support internal and external audits, including FDA, ISO, and customer audits.
• Author, review, and approve SOPs, work instructions, deviations, CAPAs, and change controls.
• Ensure compliance with cGMP/cGLP/cGCP and applicable quality standards (e.g., ISO 13485, 21 CFR Part 11, Part 210/211).
• Support validation activities, including equipment qualification and process validation documentation.
• Perform root cause analysis and develop effective corrective and preventive actions.
• Collaborate cross-functionally with Operations, Manufacturing, QC, R&D, and Regulatory teams.
• Monitor quality metrics and drive initiatives for continuous quality improvement.
• Maintain and improve document control and training systems.

Qualifications:

• Bachelor’s degree in a life science, engineering, or related field (advanced degree a plus).
• 3-5 years of quality assurance experience in a regulated environment (biotech, pharma, medical device, etc.).
• In-depth knowledge of quality systems and regulatory guidelines (e.g., FDA QSR, ISO 9001/13485, ICH Q10).
• Experience with electronic quality management systems (eQMS) such as MasterControl, Veeva, TrackWise, etc.
• Strong problem-solving skills with the ability to influence and drive change.
• Excellent attention to detail, documentation, and communication skills.

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