QA Specialist V
ASK ConsultingMorrisville, NCjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionUses quality tools (i.e. FMEA, etc.) to systematically assess assay technical and process risks and recommend mitigation actions. Participates in the development and approval for quality system procedures, laboratory documentation and controls with limited direction. Leads nonconformance, corrective and preventative action, quality metrics investigations, root cause analyses with resulting process improvements, and the verification of the effectiveness of actions as periodically required during the identification and resolution of issues. Support audits and audit-related questions within their scope of work and management of CAP, CLIA, NYS, and laboratory agencies. Prepares and conducts trainings internal and external to the Quality Assurance department when a knowledge gap is identified. Ensure all activities are conducted in compliance with the client Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations. Effectively collaborate with a fully integrated team to facilitate the completion of documents. Conducts and coordinates laboratory walkthroughs and audits utilizing the necessary laboratory requirements and regulations. Coordinate the audit response process as it pertains to laboratory findings. Provide support and contribute to other QA activities and projects as needed. Approve incoming materials, NCRs, PTCs, CAPAs, scrap and equipment comparability reports for US laboratory sites along with other documents that require review. Travel domestically up to 5% of the time. Other duties as assigned. Advanced Degree in the Sciences, Engineering, Business or a related field Experience with next generation sequencing methodology ASCP or AMT certified Medical Technologist or Clinical Laboratory Scientist Experience with lab operations Demonstrated capacity to work in a fast-paced environment with strong attention to detail Evidence of knowledge of molecular biology Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, in particular standards set forth by the International Electrotechnical Commission and International Organization for Standardization Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards Comprehensive knowledge of Good Manufacturing Practices and Good Documentation Practices Working knowledge of Next Generation Sequencing Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint Proficiency in relevant analytical methodology and emerging new technologies Strong skills in troubleshooting and problem solving Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team Understanding of HIPAA and importance of privacy of patient data Commitment to client values : patients, innovation, collaboration, and passion
Qualifications :
- Requires a minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a PhD without experience; or equivalent work experience.
Job Description :
Skills :
About ASK : ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.
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Qa Specialist • Morrisville, NC