Sr QA Specialist, Lab Operations
Company: Disability Solutions
Location: Boston
Posted on: April 19, 2024
Job 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
- 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.
Qualifications:
Basic Qualifications:
- 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
Preferred Qualifications:
- 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
#LI-Onsite
Keywords: Disability Solutions, Somerville , Sr QA Specialist, Lab Operations, Healthcare , Boston, Massachusetts
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