Synergy Bioscience is a pharmaceutical and biotech CRDMO providing development, manufacturing, testing, and regulatory compliance consulting services. Our work supports organizations navigating complex quality and regulatory demands across the product lifecycle, with a focus on maintaining rigorous standards in highly regulated environments.
As a QA/RA Specialist, you will play an important role in helping maintain the quality and regulatory foundation behind laboratory and manufacturing operations. This role is well suited to someone who brings strong judgment, a detail-oriented approach, and the ability to work across teams to support compliant, consistent, and effective quality systems.
Responsibilities
• 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.
• Provide GLP/GMP regulatory compliance training to laboratory and manufacturing staff.
• Investigate and support resolution of deviations, non-conformances, and CAPA activities.
• Maintain readiness of the facility for upcoming audits.
• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.
• 10+ years of QA/RA experience in pharmaceutical environments working under both GLP and GMP standards.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements.
• Hands-on experience conducting internal audits and inspections, investigating deviations and non-conformances, and supporting CAPA activities.
• Experience managing regulatory submissions and responses to regulatory agencies.
• Proven ability to lead cross-functional compliance activities across the product lifecycle.
• Experience training laboratory staff on quality system requirements and regulatory standards.