Job Description
Software Guidance & Assistance, Inc., (SGA), is searching for an
Clinical Laboratory Scientist for a CONTRACT assignment with one of our premier BioTech clients in Morrisville, NC . The Quality Engineer in the Quality Assurance department is a key and critical role at and works with various teams . 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 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.
Responsibilities :
- Uses 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.
- Collaborates with cross-functional teams as assigned to ensure successful project and remediation closure. Review and support, as needed, supplier and reference laboratory capability audits and provide support for startup and issue resolution.
- 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 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.
Required Skills :
- Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
- Requires a minimum of 5 years of related experience
- 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 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 values: patients, innovation, collaboration, and passion
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy
Job Tags
Contract work, Work experience placement,