Sr. QA Specialist, Supplier Qualification and Auditing
Company: Spark Therapeutics, Inc.
Location: Philadelphia
Posted on: February 25, 2021
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Job Description:
Join the Spark TeamWe were born of innovation, springing from
the curiosity, imagination and dedication of remarkable scientists
and healthcare visionaries. Our shared mission is to challenge the
inevitability of genetic disease by discovering, developing, and
delivering treatments in ways unimaginable - until now.We don't
follow footsteps. We create the path.Primary DutiesWorking under
minimal supervision, the Sr Quality Assurance Specialist,
Compliance will work closely with QA and Manufacturing Functional
Management to identify strategies, tactics and objectives for
product quality and GMP compliance:* Perform external audits of
vendors and suppliers and generate reports providing
recommendations on results of audit * Perform internal audits of
GMP and other departments as needed to assess compliance with
approved operating procedures and GMP regulations *
Review/Approve/Write/Revise Standard Operating Procedures related
to departmental activities * May act as a mentor, providing general
guidance and instructions to less senior members of the team *
Generate trending reports to update management of various
department on GMP Compliance status * Manages receipt, response to
and record keeping of product complaints * Manage the Quality
Agreements Program Responsibilities* Conducts internal and external
audits and works with vendors / internal departments to ensure
appropriate responses are submitted in timely fashion * Manages and
tracks corrective actions (CAPA's) and works with departments on
completing them on time * Works with functional departments in
collecting data trends of critical operations within these
departments and generated trending reports for cross functional
review * Manages product complaint system * Helps maintain supplier
qualification schedule and vendor status reports * Assists Training
Lead in ensuring training programs are compliant and up to date *
Support preparation of regulatory submissions * Other assigned
responsibilities as established by QA Lead Education And Experience
Requirements* BA/BS in scientific discipline required or equivalent
work experience * A minimum of 5-7 years in a global pharmaceutical
manufacturing environment with exposure to Quality and
Manufacturing field * Experience in conducting internal and
external audits * Broad working knowledge of relevant governmental
regulations, cGMP and guidelines (US, EU and other territories
where Spark products are distributed), and ability to organize cGMP
procedures based on regulatory / compliance regulations * Travel up
to 25% may be required * The position may require occasional shift
work, including weekends, off hours and holidays as needed. * Key
Skills, Abilities, and Competencies * Broad knowledge of CGMP
Regulations * Quality Systems such as Supplier Qualification, CAPA
management, * Ability communicate effectively with wide range of
personnel * Solid technical writing skills related to investigation
reports * Ability to organize cGMP system procedures based on
regulatory / compliance regulations * Must have strong attention to
detail * Strong analysis and problem solving skills, including, but
not limited to, the ability to review and analyze Manufacturing,
Quality Control and validation data * Ability to lead (as
necessary) and participate on cross-functional teams in root cause
analysis and solution identification * Proficiency with computer
programs
Keywords: Spark Therapeutics, Inc., Philadelphia , Sr. QA Specialist, Supplier Qualification and Auditing, Other , Philadelphia, Pennsylvania
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