What are the responsibilities and job description for the Quality Assurance (QA) Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing.
- Conduct inspections, audits, and testing to ensure products meet quality standards.
- Review batch records, documentation, and processes for compliance with quality protocols.
- Investigate deviations, non-conformances, and customer complaints, implementing corrective actions.
- Assist with the preparation for regulatory audits and inspections.
- Support the development and maintenance of quality assurance systems and procedures.
- Collaborate with cross-functional teams to resolve quality issues and improve processes.
- Review and update Standard Operating Procedures (SOPs), batch records, and documentation.
- Train staff on GMP guidelines and company quality policies.
- Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or a related field.
- 2 years of experience in Quality Assurance, preferably in the pharmaceutical or biotechnology industry.
- Strong understanding of GMP, FDA regulations, and industry standards.
- Experience with pharmaceutical manufacturing processes and quality control testing.
- Strong attention to detail and communication skills.
- Proficiency with Microsoft Office Suite; experience with quality management software is a plus.
