Title: QA Engineer Duration: 05 months Location: Boston, MA 02210
Duties: The Quality Engineer in the Quality Assurance department is a key and critical role at the client and works with various teams within the 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 the client’s 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.
Support audits and audit-related questions within their scope of work and management of CAP, CLIA, NYS, and laboratory agencies.
Prepares and conducts training, internal and external to the Quality Assurance department, when a knowledge gap is identified.
Ensure all activities are conducted in compliance with the client’s 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.
Work and interact cross-functionally with various teams to foster a solution-focused approach to opportunities.
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 field
Experience with next-generation sequencing methodology
ASCP or AMT certified Medical Technologist or Clinical Laboratory Scientist
Experience with lab operations
Demonstrated ability to lead, communicate, interact, and influence effectively at technical levels across functions
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 the 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 the importance of the privacy of patient data
Commitment to the client’s values: patients, innovation, collaboration, and passion
Education:
Requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $49.00/hr.
