Senior Associate, Gene Therapy Quality Assurance
Company: Sarepta Therapeutics, Inc.
Location: Andover
Posted on: January 27, 2023
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Job Description:
The QA Senior Associate is primarily responsible for quality
oversight and guidance of in-house testing facilities with
additional supporting oversight for contract testing labs. The
Senior Associate will be a key member of QA team and oversee the
quality systems to be developed and approved for implementation in
the testing operations. In addition, they will be responsible for
ensuring Sarepta's quality policies, practices, procedures
standards, and systems for necessary adherence to aseptic
production and product management in accordance to the cGXP
compliance to US, ATMP and EU regulations are being
maintained.Primary Responsibilities Include:Actively participates
as a member of the Quality Ops Team and partners with the Quality
Control and analytical team.Support Testing Operations during batch
production and disposition, ensuring unexpected events are handled
compliantly and in a timely manner.Review and approve documents
including testing documentation in support of product disposition
and stability; Standard Operating Procedures.Monitor and report
metrics and manage routine measurement.Perform data review,
analysis, identification of trends, and complex problem
solving.Assist with problems of diverse scope using a high degree
of judgment and risk-based decision makingApprise senior management
of critical issues.Champion process improvement concepts.Evaluates
the functional strengths and developmental areas in the Quality
organization and focuses on continuous improvement.Support a state
of continuous inspection readinessMay work directly and build
cross-functional relationships with Engineering, Facilities,
Analytical Development and Regulatory.Desired Education and Skills:
BS/MS in Biology discipline and 8+ years of experience in a cGMP
environment, with strong knowledge of FDA, EU, ATMP and JP
regulations. Experience in setting up GMP operations and systems in
new facility is beneficial.Detail oriented and the ability to
communicate effectively, proactively and professionally to clients
and members of the management team.Skilled in use of Microsoft
Outlook, PowerPoint, Word, Excel and GMP system programs and
spreadsheets is mandatory, as is a capacity to follow written
procedures, and the ability to read, write, speak, understand and
to be understood in English.This position requires work on site at
one of Sarepta's facilities in the United States. Candidates should
be aware that Sarepta currently maintains a policy requiring all
US-based employees to be fully vaccinated against COVID-19 in order
to work on site. Newly hired employees must be vaccinated prior to
their employment start date. Sarepta is an equal opportunity
employer and will provide a reasonable accommodation to those
unable to be vaccinated where it is not an undue hardship to the
company to do so as provided under federal, state, and local
law.Candidates must be authorized to work in the U.S.Sarepta
Therapeutics offers a competitive compensation and benefit
package.Sarepta Therapeutics is an Equal Opportunity/Affirmative
Action employer and participates in e-Verify.#LI-JL1
Keywords: Sarepta Therapeutics, Inc., Boston , Senior Associate, Gene Therapy Quality Assurance, Other , Andover, Massachusetts
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