- Assist in all aspects of the full operation, implementation, and maintenance of the Quality Management System (QMS) to ensure continued compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the College of American Pathologists (CAP) standards.
- Review and approve the information to ensure it meets FMI standards and procedures and is clearly and appropriately justified as applicable, including but not limited to:
- Non-conformance reports.
- Deviation Investigations.
- Corrective Action Preventative Action reports.
- Quality Control records.
- Process Improvement.
- Maintain availability to the wider FMI business to consult and provide guidance on Good Practice (GxP) quality guidelines and specific regulations, including but not limited to:
- Clinical Laboratory Improvement Amendments of 1988 (CLIA);
- College of American Pathologists accreditation standards.
- 21 CFR Part 11 compliance.
- Laboratory state regulations including Massachusetts, California, New York, and applicable state agencies.
- Trigger risk assessment process as required per established regulations or procedures and coordinate and lead analyses.
- Provide departmental training as needed as part of Site New Employee Onboarding Training.
- Actively communicate with the various areas and departments to identify areas of improvement.
- Serve as a quality partner to operations
- Assist with the implementation of new processes to streamline current business and system practices to regulatory compliance with key stakeholders and department leaders.
- Create, review, and approve documents including Standard Operating Procedures, Quality Metrics Reports, Annual Product Reviews, and other documents, as needed.
- Coordinate the audit response process as it pertains to laboratory findings.
- Maintain organization and attention to detail in a fast-paced workflow environment.
- Assist with internal and external audits as necessary.
- Support FDA, NYS DOH, CAP, and other regulatory agency inspections.
- Provide support and contribute to other QA activities as needed.
- Participate in projects associated with Quality activities as needed.
- Work and interact cross-functionally with a wide variety of people and teams to foster a solution-focused approach to opportunities.
- Approve incoming materials "on floor" in the materials department.
- Travel domestically up to 5% of the time.
- Other duties as assigned.
- 0-3 years of prior experience with patient testing laboratory quality
- Bachelor of Science Degree
- Alternatively, an associate degree in laboratory science or a related field with 5+ years of experience in a clinical laboratory
- Bachelor's Degree in science or a related field
- ASQ certification or ASCP/AMT Certification
- 5+ years of experience in the pharmaceutical, biotechnology, medical device, diagnostics, or clinical laboratory industries
- Prior experience working in a QA environment
- Working knowledge of applicable business systems including: Veeva, Maximo, LIMS, and Smartsheet
- Exposure to regulatory compliance knowledge including ISO 15189, CLIA, CAP, NYSDOH, state requirements, GxP, and 21 CFR Compliance
- Ability to multitask within specified timelines
- Ability to work well under pressure while maintaining a professional demeanor
- Detail-oriented with excellent prioritization and organizational skills
- Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem-solving with departments and colleagues
- Understanding of HIPAA and the importance of privacy of patient data
- Commitment to FMI values: patients, innovation, collaboration, and passion
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Sr QA Specialist, Lab Operations - Boston, United States - Foundation Medicine
Description
About the Job
Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
Key Responsibilities
Qualifications:
Basic Qualifications:
Preferred Qualifications:
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