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Open nowPosted 15 days ago

QA/RA Specialist

Workable (global search)108,016 open roles

Where
Dallas, Texas, United States
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Your applicationOpen nowQA/RA SpecialistWorkable (global search) · Dallas, Texas, United States
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7.9% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 7 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 7.9%7 days
  4. 14.9%14 days
  5. 34.0%30 days
This job: posted 15 days ago

Workable (global search) median: 7 days open

The posting

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.

Benefits

  • Health Care Plan (Medical, Dental & Vision)
  • Paid Time Off (Vacation, Sick & Public Holidays)
  • Training & Development
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