Pharmaceutical GMP QA Specialist
Synergy Bioscience, Inc. · Dallas, TX · 3 mo ago
On-siteQuality AssuranceFull-time
Key Responsibilities
- Ensure adherence to pharmaceutical GMP regulations and internal quality standards
- Conduct routine and for-cause internal audits and inspections of chemistry, microbiology, and molecular biology laboratories
- Review and approve GMP-related documentation, including test results, technical reports, investigation reports, and SOPs
- Collaborate with cross-functional teams to address non-conformities and implement corrective and preventive actions (CAPAs)
- Coordinate with cross-functional teams to address non-conformities and implement corrective and preventive actions (CAPAs)
- Support regulatory inspections and manage responses to audit findings
- Maintain quality metrics and report on compliance status
- Provide training and guidance on GMP requirements to laboratory personnel
Requirements
- Education: Bachelor's degree in Chemistry or Microbiology
- Experience: 10 + years of experience in pharmaceutical quality assurance or GMP compliance
- Familiarity with the FDA, DEA, and the iSO 17025 regulations and requirements
- Experience in conducting audits and managing quality systems
Skills
- Strong analytical and problem-solving abilities
- Excellent communication and interpersonal skills
- Ability to work collaboratively in cross-functional teams
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Training & Development