Senior QA/RA Specialist - CRO Experience
Location: Dallas, Texas
About Synergy Bioscience:
Synergy Bioscience is a leading Contract Research Organization (CRO) specializing in pharmaceutical product development, analytical chemistry, and microbiology testing services across various industry sectors. We are committed to excellence and innovation, and we are looking for a proactive, detail-oriented, and experienced Quality Assurance Specialist to join our team at our Dallas facility.
Position Summary:
The Quality Assurance Specialist will play a critical role in maintaining and improving our quality management system to ensure compliance with regulatory standards, including 21 CFR Parts 11, 210, 211, 600s, and 820, as well as ISO 17025, EPA, and CLIA requirements. The ideal candidate will collaborate with cross-functional teams to establish, document, and enforce quality processes that meet regulatory and client expectations.
Key Responsibilities:

• Quality Documentation: Develop, maintain, and ensure alignment of quality system documentation with regulatory standards, including 21 CFR Parts 11, 210, 211, 600s, and 820, ISO 17025, EPA, and CLIA.
• Standard Operating Procedures (SOPs): Write and revise SOPs and Work Instructions to ensure regulatory compliance.
• Training: Design and deliver regular training programs on QA procedures and other critical compliance needs for staff.
• Compliance Oversight: Manage and coordinate quality assurance activities, including tracking deviations, out-of-specification (OOS) investigations, and corrective and preventive actions (CAPAs) to ensure timely resolution.
• Internal Audits: Conduct periodic internal audits to assess compliance with established SOPs, training requirements, and regulatory standards.
• Risk Management: Perform risk assessments, identify gaps in the quality system, and implement corrective and preventive actions to address non-conformities.
• Process Improvement: Lead cross-functional teams in process improvement initiatives and document reviews to enhance operational efficiency.
• Continuous Improvement: Establish systems for ongoing quality improvements based on client feedback and inter-departmental collaboration.

Qualifications:

• Proven experience in quality systems within the pharmaceutical or life sciences industry.
• Strong knowledge of FDA regulations, cGMP requirements, and laboratory operations.
• Exceptional written and verbal communication skills.
• Attention to detail with excellent problem-solving and critical-thinking abilities.
• Experience in conducting internal audits and recommending compliant solutions.
• Familiarity with general laboratory equipment is a plus, but not required.

Why Join Synergy Bioscience?
This is an opportunity to be part of a dynamic and growing organization where your skills and expertise will make a meaningful impact. We value innovation, collaboration, and commitment to quality, and we offer a supportive work environment where you can thrive professionally.
How to Apply:
Interested candidates are encouraged to submit their resume and cover letter highlighting their top skills and expected salary requirements.