QA/RA Specialist

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 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. 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. Health Care Plan (Medical, Dental & Vision) Paid Time Off (Vacation, Sick & Public Holidays) Training & Development #J-18808-Ljbffr synergy