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Job opportunity
QA/RA Specialist
synergy
Dallas, Texas, US
Source: synergy careers · View original posting
- Employment
- full time
Employer job description
From synergy's posting. “We” and “our” refer to the employer.
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 the product lifecycle.
- Provide GLP/GMP regulatory compliance training to laboratory and manufacturing staff.
- Investigate and support resolution of deviations, non-conformances, OOS, and CAPA activities.
- Maintain readiness of the facility for upcoming audits.
Requirements
- 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 or GMP standards.
- Strong knowledge of FDA, EMA, and ICH regulatory requirements.
- Hands-on experience conducting internal audits and inspections, investigating deviations, out-of-specification, and CAPA investigations.
- Experience managing regulatory submissions and responses to regulatory agencies.
- Experience training laboratory staff on quality system requirements and regulatory standards.