Working under minimal supervision, the Sr Quality Assurance Specialist-Auditing 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
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
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
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
About Spark Therapeutics, Inc.
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are des...igned to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease.Our missionChallenge the inevitability of genetic disease by discovering, developing and delivering treatments in ways unimaginable – until now.Our visionA world where no life is limited by genetic disease.
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