What are the responsibilities and job description for the Quality Assurance Associate position at Harba Solutions Inc.?
Job Responsibilities:
- Assist in maintaining and improving the company’s QMS to ensure compliance with ISO, GxP (Good Laboratory/Manufacturing Practices), and FDA regulations.
- Review, approve, and maintain records, including Standard Operating Procedures (SOPs), validation protocols, batch records, and regulatory documentation. Ensure proper documentation practices in line with regulatory requirements.
- Participate in internal audits, assist with regulatory inspections, and support the preparation and follow-up of audit activities. Ensure any non-conformances or observations are properly addressed and documented.
- Monitor adherence to company policies and regulatory requirements, helping to identify and resolve potential compliance issues.
- Support risk assessments related to the development and manufacturing of products.
- Help deliver quality-related training to staff members to ensure proper understanding and compliance with quality standards.
- Analyze data from production, testing, and validation processes to identify trends and areas for improvement. Prepare regular reports for quality reviews.
- Support CAPA processes by investigating issues, analyzing root causes, and helping to develop and implement corrective actions.
- Work cross-functionally with research, product development, manufacturing, and regulatory teams to ensure alignment on quality standards and objectives.
Qualifications:
- Education: Bachelor’s degree in Biology, Biotechnology, Chemistry, Life Sciences, or related field.
- Experience:
- At least 1-2 years of experience in quality assurance, quality control, or a related role within the biotechnology, pharmaceutical, or research industry.
- Familiarity with regulatory standards (ISO, FDA, GxP, etc.) and laboratory/production environments.
- Experience with document control and audit processes is a plus.
Salary : $25 - $30
