Senior Quality Assurance Specialist, External Quality, Ocular
Company: Editas Medicine
Location: Cambridge
Posted on: February 16, 2021
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Job Description:
What if you could repair broken genes? That is the question we
ask ourselves at Editas Medicine. We're focused on translating the
power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known
as Cas12a) genome editing systems into a robust pipeline of
medicines for people living with serious diseases around the world.
Our goal is to discover, develop, manufacture, and commercialize
transformative, durable, precision genomic medicines for many
diseases. We're looking for talented, dedicated, passionate people
to join our team and help us pioneer this field and do big, bold
things that have never been achieved before. Are you full of hope,
possibilities, and a belief that, working together, we can truly
revolutionize the development of medicines to help patients around
the world? If the answer is yes, then Editas Medicine is the place
for you.Editas is seeking a highly motivated and experienced
quality professional to manage the quality activities at contract
manufacturing organizations (CMOs) and Contract Testing
Organizations (CTOs) and to serve as the Quality Lead for external
partnerships. This position will be responsible for managing all
activities associated with product disposition and release testing
at CMOs and CTOs. The ideal candidate will have experience in the
Biopharmaceutical industry in QA and QC.Responsibilities will
include* Provide QA leadership for Ocular programs and the QA
Ocular team* Act as QA Lead for tech transfer, process development,
and process validation for Editas Ocular programs* Quality
Assurance Lead for external collaborations to provide quality
system expertise and help identify solutions and ensure compliance
to GMP* Author, review and approve GMP documentation (SOPs, batch
records, protocols, technical reports, test methods, protocols,
specifications, and summary reports to support GMP manufacturing).*
Support External Quality partnerships as required in the initiation
and follow up of deviations, CAPAs, and change controls.* Build on
relationships within our CTOs and CMOs ensuring issues impacting
quality control testing are tracked and resolved in a timely
manner.* Responsible for compliance with documentation management
system (quality agreements, CMO performance evaluations, master
batch records, analytical data, etc.).* Support projects, and
global processes alignment (internal and external) as well as
continuous improvement and initiatives.* Review executed batch
records, associated testing records, and other documentation to
ensure that all steps have been executed correctly, and that all
limits and specifications have been met.* Review and approve
deviations, change controls and CAPAs for appropriateness,
completeness and to meet internal procedures and regulatory
expectations.* Work collaboratively with cross functional teams,
partners, and vendors to gather background knowledge needed to
complete assignments.* Develop and maintain Quality Agreements with
contract manufacturers, suppliers, and laboratories* Independently
coordinates complex investigations in cross-functional areas.*
Anticipate issues and escalate to appropriate management attention
immediately.* Exercises judgment in resolving moderate to complex
quality issues.* Plan and execute work independently and consult
with supervisor as needed.* Supports the organization in
maintaining inspection readiness.* Review and approve validation
protocols and reports to ensure compliance* Review analytical
results, and documents associated with investigations, OOS results,
etc., and corrective/preventive action plans* Support generation of
metrics for Management Review* Review stability protocols and
reports* Conduct internal and external audits as required, track
progress, and trend results* Occasional travel will be required
Requirements* A Bachelor's or Master's degree in biology, chemistry
or other life science and at least 7 years of relevant industry
experience in Quality Assurance in a Pharmaceutical/Biotech GMP
environment* A solid understanding of applicable regulations and
guidelines pertaining to pharmaceutical product development.
manufacturing, testing and clinical operations * Experience with
GMP's in a working manufacturing environment strongly preferred* A
working knowledge of GMP requirements for Clinical Trial Material
in both the US and EU including sterile manufacturing strongly
preferred* Certified Quality Auditor (CQA) would be a plus*
Investigational skills including Root Cause Analysis and Product
Impact Assessments* Ability to manage multiple projects with
minimal oversight in and evolving environment* Strong communicator
and collaborator who possesses a flexible approach to problem
solving and ability to apply risk-based decision making
Keywords: Editas Medicine, Cambridge , Senior Quality Assurance Specialist, External Quality, Ocular, Other , Cambridge, Massachusetts
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