Elevate product quality and compliance in a critical mid-level role. As a Quality Assurance specialist, you will directly manage and enhance our core quality systems, ensuring adherence to global standards and preparing us for successful regulatory outcomes. Your expertise will be vital in maintaining our reputation for excellence and directly contributing to product integrity.
Responsibilities
Manage the complete lifecycle of Standard Operating Procedures (SOPs), from drafting and review to approval and obsolescence.
Lead the investigation, documentation, and resolution processes for deviations, Corrective and Preventive Actions (CAPAs), and change controls.
Execute and oversee the internal audit program, including scheduling, conducting audits, reporting findings, and tracking corrective actions.
Conduct thorough vendor qualification audits and maintain the approved vendor list in accordance with quality standards.
Provide critical support and documentation during external regulatory inspections (FDA, NABL).
Requirements
3+ years of direct experience in Quality Assurance within a regulated industry (e.g., life sciences, biotech, medical device).
Demonstrated expertise in GMP/GLP/ISO quality systems and their practical application.
Proven track record in managing SOPs, deviations, CAPAs, and change controls from initiation to closure.
Familiarity with regulatory inspection processes, particularly FDA and NABL guidelines.
Bachelor's degree in a scientific or engineering discipline.
Ability to work effectively onsite at our facility.
Nice-to-Haves
Experience with electronic Quality Management Systems (eQMS).
Certified Quality Auditor (CQA) or similar professional certification.
Master's degree in a relevant field.
What We Offer
The autonomy to shape and improve critical quality assurance processes.
Direct influence on product integrity and regulatory compliance.
A culture that prioritizes precision, quality, and continuous improvement.
Competitive compensation package and comprehensive benefits.
Opportunities for professional development and training in advanced QA methodologies.