Pharmaceutical GMP QA Specialist

Synergy Bioscience is a Contract Research Organization (CRO) providing pharmaceutical product development support, analytical chemistry, and microbiology testing services to the FDA-regulated industry sectors. We seek a dynamic and experienced GMP/GLP Quality Assurance Specialist to join our team at our Dallas, Texas facility. The successful candidate will be responsible for ensuring the continued compliance of laboratory operations and its quality system writing quality system-related Standard Operating Procedures (SOP) and Work Instructions (WI) and reviewing Quality Management System documents to ensure compliance with the requirements of regulatory requirements.

Responsibilities:

• Coordinate and establish quality system documentation, align with the requirements of 21 CFR Parts 11, 210, 211, 600s, and 820 and ISO 17025, EPA, and CLIA, and provide consultative services.
• Write SOPs and Work Instructions to meet the regulatory compliance of 21 CFR, ISO 17025, CLIA, and EPA.
• Develop and deliver training on QA procedures and other critical needs.
• Oversee and coordinate quality assurance compliance activities, including tracking of deviations, OOS investigations, and CAPAs to completion.
• Conduct internal audits to ensure conformance to established SOPs, documents, training requirements, and other regulatory compliance requirements.
• Perform risk assessments, identify gaps in the quality system, and implement corrective actions.
• Lead cross-functional teams for process improvement and document review.
• Establish systems for continuous improvement based on feedback from clients and departments.

• Bachelors in Chemistry, Biology, or Pharmaceutical with a minimum of 5 years industry experience.
• Masters in Chemistry, QA, and Regulatory Affairs with a minimum of 3 years industry experience.
• Previous experience in pharmaceutical quality systems functions.
• Knowledge of FDA regulations and cGMP work requirements as they relate to lab operations.
• Strong written and oral communication skills.
• Attention to detail and problem-solving abilities.
• Experience in conducting internal audits and recommending a compliant course of action.
• Ability to use general laboratory equipment is a plus but not necessary.