Pharmaceutical GMP QA Specialist

Synergy is seeking a detail-oriented and experienced Pharmaceutical GMP QA Specialist to ensure compliance with Good Manufacturing Practices (GMP) in pharmaceutical development and testing processes. The QA Specialist will be responsible for implementing and maintaining quality management systems, conducting inspections and audits, reviewing documentation, and ensuring all activities adhere to regulatory standards, including FDA, DEA, and ISO 17025 requirements. This role requires close collaboration with the development and testing teams to maintain compliance with the regulatory requirements.Key Responsibilities:Ensure adherence to pharmaceutical GMP regulations and internal quality standardsConduct routine and for-cause internal audits and inspections of chemistry, microbiology, and molecular biology laboratoriesReview and approve GMP-related documentation, including test results, technical reports, investigation reports, and SOPsCoordinate with cross-functional teams to address non-conformities and implement corrective and preventive actions (CAPAs)Support regulatory inspections and manage responses to audit findingsMonitor quality metrics and report on compliance statusProvide training and guidance on GMP requirements to laboratory personnelEducation & Experience:Bachelor's degree in Chemistry or MicrobiologyMinimum 10 years of experience in pharmaceutical quality assurance with strong knowledge of GMP regulationsExperience working within the FDA, DEA, and ISO 17025Proven ability to conduct audits and manage quality documentationStrong communication, analytical, and interpersonal skillsRequirementsEducation:Bachelor's degree in Chemistry or MicrobiologyExperience:10 + years of experience in pharmaceutical quality assurance or GMP complianceFamiliarity with the FDA, DEA, and the iSO 17025 regulations and requirementsExperience in conducting audits and managing quality systemsSkills:Strong analytical and problem-solving abilitiesExcellent communication and interpersonal skillsAbility to work collaboratively in cross-functional teamsBenefitsHealth Care Plan (Medical, Dental & Vision)Paid Time Off (Vacation, Sick & Public Holidays)Training & Development