Synergy Bioscience is a CRO providing pharmaceutical product development support, analytical chemistry, and microbiology testing services to different industry sectors. We are seeking a dynamic and experienced Quality Assurance Specialist to join our team at our Dallas, Texas facility. The successful candidate will be responsible for the development and maintenance of our Quality Management System to comply with the requirements of 21 CFR, A2LA, CLIA, and EPA.
Responsibilities:- Coordinate and establish quality system documentation, align with the requirements of 21 CFR Parts 11, 210, 211, 600s, and 820 as well as 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.
Qualifications:- Bachelor's Degree in a related field with 5 - 7 years of experience in quality assurance functions.
- Knowledge of FDA regulations and cGMP work requirements.
- Proficient in Microsoft Office.
- Strong written and oral communication skills.
- Analytical skills with 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 and advanced computer proficiency.