This job has expired

GMP Auditor

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Jul 1, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma
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Job Details

Primary Duties

    The GMP Auditor will work closely with QA, QC, Materials Management and External Manufacturing to assist in identifying 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, Work Instructions, Policies, Protocols and Reports related to departmental activities Generate trending reports to update management of various departments on GMP Compliance status Manage the receipt and processing of Supplier Change Notifications Monitor the performance of Suppliers, Contract Testing Laboratories and Contract Manufacturing Organizations to determine appropriate oversight and GMP compliance. Participate in inspection preparedness to maintain inspection readiness.

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 external suppliers / 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
  • Helps maintain the internal and external auditing schedules and vendor status reports
  • Conduct Supplier Performance Monitoring documenting compliance status
  • Support receipt and tracking of supplier change notifications
  • Assist in inspection preparation activities
  • Other assigned responsibilities as established by QA Supplier Qualification & Auditing Lead

Education and Experience Requirements

  • BA/BS in scientific discipline or equivalent work experience
  • A minimum of 5-7 years in a global pharmaceutical / biotech manufacturing environment with exposure to Quality and Manufacturing fields
  • Experience participating / leading internal and external audits
  • 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

Key Skills, Abilities, and Competencies

  • Knowledge of domestic and international CGMP Regulations
  • Quality Management Systems such as Supplier Qualification Change Control and CAPA management
  • Ability to communicate effectively with wide range of personnel
  • Solid technical writing skills related to audit reports
  • Ability to organize cGMP system procedures based on regulatory / compliance regulations
  • Must have strong attention to detail
  • Strong analysis and problem-solving skills
  • Participate on cross-functional teams in supplier identification and qualification
  • Proficiency with computer programs

Complexity and Problem Solving

  • Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.
  • Works under minimal supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
  • Contributes to the completion of organizational projects and goals.
  • Ability to establish facts, define problems, collect data and draw valid conclusions
  • Ability to work collaboratively in the process of problem solving of any issues related to the quality systems processes
  • Ability to be assertive to ensure conformance to cGMPs while maintaining a collaborative environment

Internal and External Contacts

  • Frequent internal company and external contacts. Represents organization on specific projects

Other Job Requirements

  • Travel up to 30% may be required
  • The position may require occasional shift work, including weekends, off hours and holidays as needed.

#LI-2326

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



Join the Spark Team

We 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.

Company

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 designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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