Intern, Quality Assurance
Company: Foundation Medicine, Inc.
Location: Cambridge
Posted on: January 27, 2023
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Job Description:
Job DescriptionAbout the Job The Intern, Quality Assurance
assists with quality assurance activities to ensure compliance with
CLIA, CAP, FDA, and IVDR regulations and requirements. This
position may assist with specific project work related to Design
History Files, Post Market Surveillance, Training Strategy,
Corrective and Preventive Actions , laboratory compliance, or in
collaboration with cross-functional teams to elevate FMI's systems
in an efficient and compliant manner. The intern will contribute to
general quality operations and documentation practices, such as
data entry, tracking of documents, generating of metrics, and
assisting in process improvement efforts. The position will offer
opportunities to learn how to obtain, trend, and analyze quality
metrics. The FMI Internship Program is offered to students
currently registered in a degree program. It is a 10-12 week summer
commitment, Full Time, 40 hours/week. Interns will gain a greater
understanding of FMI through challenging project-based work,
Spotlight Speaker Series with company executives, and the chance to
connect with all employees by attending many company-wide events.
Foundation Medicine is unable to consider candidates that will
require visa sponsorship now, or in the future, for this specific
role. Key Responsibilities Maintain and assist with updating
policies and protocols. Gain knowledge of record keeping under
medical device and laboratory requirements. Support and assist
validation documentation activities as required. Assist with
building systems with Licensure teams to ensure ongoing compliance
with laboratory regulations. Assist in aspects of the full
operation, implementation, and maintenance of quality systems
Support FDA and other regulatory agency inspections in backroom
support/document retrieval. Work with management in compiling
required metrics and data for monthly Quality meetings and/or
management review activities. Assist the Post Market function in
supporting regulatory compliance for both laboratory and device
complaints utilizing our recently implemented electronic system.
Assist the process for post market data gathering and analysis.
Results are presented, on a regular basis, to cross functional
leadership to support data driven decisions. Provide support and
contribute to other Quality Assurance activities as needed.
Qualifications Basic Qualifications Rising senior enrolled in an
accredited college or university pursuing a Bachelor's degree in a
life science, engineering, business or equivalent field Preferred
Qualifications Prior experience working with Record Management
Prior experience working with electronic document management and
quality management systems Current or prospective student in an
NAACLS approved Clinical Laboratory Scientist program Excellent
attention to detail with excellent prioritization and
organizational skills Superior analytical and problem-solving
skills Understanding of HIPAA and the importance of patient data
privacy Commitment to reflect FMI's values: Passion, Patients,
Innovation, and Collaboration #LI-HybridAbout UsFoundation
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
helps 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. Foundation Medicine is proud to be an Equal Opportunity
and Affirmative Action employer and considers all qualified
applicants for employment without regard to race, color, religion,
sex, gender, sexual orientation, gender identity, ancestry, age, or
national origin. Further, qualified applicants will not be
discriminated against on the basis of disability or protected
veteran status. We also consider qualified applicants regardless of
criminal histories, consistent with legal requirements. See also
FMI's EEO Statement and EEO is the Law and Supplement. If you have
a disability or special need that requires accommodation, please
let us know by completing this form. (EOE/AAP Employer)
Keywords: Foundation Medicine, Inc., Cambridge , Intern, Quality Assurance, Other , Cambridge, Massachusetts
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