Why This Role Stands Out
This role offers a fantastic opportunity to deepen your expertise in pharmaceutical quality and regulatory affairs within a reputable CRDMO, impacting crucial product development. You will thrive here if you possess strong judgment, a detail-oriented mindset, and a collaborative spirit, making this an ideal next step for your career growth. Apply now to contribute to a dynamic team dedicated to upholding rigorous standards.
Quick Overview
Job Description
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.
- Health Care Plan (Medical, Dental & Vision)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Training & Development