| Title: | QA Specialist - CLIA Experience |
|---|---|
| ID: | 1450 |
| Location: | Dallas, TX |
| Department: | Operations |
| Job Related Skills: | 21 CFR Part 11, Analytical Chemisty, Auditing, CAPA, Data Integrity, FDA Audit Experience, FDA Regulations, Microbiology, Microsoft Office (Word, Excel, ..etc.), Pharmaceutical Development, Quality Assurance, SOP Writing |
Synergy Bioscience is a Contract Research Organization (CRO) dedicated to providing pharmaceutical development support, analytical chemistry, and microbiology testing services to FDA-regulated companies.
We are currently seeking a dynamic and experienced Quality Assurance Specialist to join our team at our facility in Dallas, Texas. The successful candidate will play a crucial role in maintaining and improving our Quality Management System to ensure compliance with regulatory requirements.
Responsibilities:
- Develop and maintain Standard Operating Procedures (SOP) and Work Instructions (WI) in accordance with 21 CFR, ISO 17025, EPA, and CLIA regulations.
- Provide consultative services to team members on quality system documentation and compliance.
- Design and deliver training sessions on QA procedures and other critical areas as needed.
- Coordinate and oversee quality assurance compliance activities, including tracking deviations, out-of-specification (OOS) investigations, and Corrective and Preventive Actions (CAPAs) until resolution.
- Conduct internal audits to assess adherence to established SOPs, documents, and regulatory requirements, and provide recommendations for improvement.
- Perform risk assessments, identify gaps in the quality system, and implement corrective actions.
- Lead cross-functional teams for process improvement initiatives and document review.
- Establish systems for continuous improvement based on client feedback and departmental needs.
Qualifications:
- Previous experience in pharmaceutical quality systems functions is required.
- Familiarity with FDA regulations and CLIA requirements related to clinical lab operations and testing is essential.
- Excellent written and oral communication skills.
- Strong attention to detail and problem-solving abilities.
- Experience in conducting internal audits and recommending compliant courses of action.
- Proficiency in using general laboratory equipment is preferred but not required.
- Prior experience with successful CLIA certification applications is a definite plus.
Join our team and contribute to the success of our organization while advancing your career in the pharmaceutical industry!
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