All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".
Job Title : QA Specialist - Clinical Laboratory Scientist I
Location : Boston, MA (Onsite)
Duration : 05 months
Pay rate : $54 hr on W2 AI
Job Description :
The Quality Engineer in the Quality Assurance department is a key and critical role at client and works with various teams within client. As part of the Laboratory Operations Quality team, this position supports day-to-day quality management laboratory activities, evaluates and designs laboratory processes in collaboration with client Operations and Pathology teams, and conducts investigations with department subject matter experts. This position supports the planning and work of multiple projects and scrum teams with a big picture mindset and is accountable for achieving all related business goals.
Education :
- 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.
Description :
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 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.Skills :
Advanced Degree in the Sciences, Engineering, Business or a related fieldExperience with next generation sequencing methodologyASCP or AMT certified Medical Technologist or Clinical Laboratory ScientistExperience with lab operationsDemonstrated capacity to work in a fast-paced environment with strong attention to detailEvidence of knowledge of molecular biologyEvidence 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 StandardizationDeep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standardsComprehensive knowledge of Good Manufacturing Practices and Good Documentation PracticesWorking knowledge of Next Generation SequencingProficiency in Microsoft Office, Word, Excel, Project and PowerPointProficiency in relevant analytical methodology and emerging new technologiesStrong skills in troubleshooting and problem solvingExcellent communication skills and proven ability to work effectively as a member of a multidisciplinary teamUnderstanding of HIPAA and importance of privacy of patient dataCommitment to client values : patients, innovation, collaboration, and passionAbout 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.
