QA/RA Specialist - Pharmaceutical GLP/GMP Experience
Synergy Bioscience, Inc. · Dallas, TX · 2 mo ago
On-siteQuality AssuranceFull-time
Key Responsibilities
- Develop, review, and maintain quality assurance and regulatory affairs documentation in compliance with GLP and GMP standards
- Ensure adherence to regulatory requirements from FDA, EMA, and other global regulatory agencies
- Conduct internal audits and inspections to assess compliance with quality systems and regulatory standards
- Support preparation and management of regulatory submissions and responses to regulatory agencies
- Collaborate with cross-functional teams to ensure compliance throughout product lifecycle
- Assist in training laboratory and manufacturing staff on quality system requirements and regulatory standards
- Investigate and support resolution of deviations, non-conformances, and CAPA activities
Requirements
- Education: Bachelor's degree in life sciences, pharmacy, chemistry, or a related discipline
- Experience: At least 5 years of hands-on experience in pharmaceutical GLP/GMP QA and regulatory affairs
- Familiarity with international regulatory frameworks including FDA, EMA, and ICH guidelines
- Proven experience conducting internal audits and supporting regulatory inspections
Skills
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal abilities
- Ability to work collaboratively with cross-functional teams and manage multiple priorities
- Proficiency in quality management systems and documentation practices