Quality Assurance Operations Intern

Primary Duties

• The Quality Assurance Intern position will report directly to the Quality Assurance Lead. The primary responsibilities of the QA Internal Manufacturing Lead include the following:
• Participate in a project to improve the efficiency of the quality release process for GMP materials at Spark Therapeutics.
• Completion of training on cGMP’s and Spark Onboarding process.
• Participate in release process for materials at Spark, as well as current labelling verification and reconciliation of incoming materials and document control processes.
• Provide Quality support for internal manufacturing processes as needed.
• Participate in record review of executed production records for reagents, bulk drug substance, drug product and packaged lots.
• Work closely with QA, QC and Manufacturing Functional Management to identify strategies, tactics and objectives for product quality and GMP compliance.
• Write/Revise Standard Operating Procedures and Technical Documents/Reports
• Provide quality oversight and assistance to Material Management for material receipt, labeling, and release.
• Review vendor certificates for completeness / compliance against approved specifications.
• Participate in implementation of key improvement initiatives and helping solve compliance issues in partnership with business process owners.
• Complete presentation showing results of project as required.

Responsibilities

• Participate in a project to improve the efficiency of the quality release process for GMP materials at Spark Therapeutics.

• Provide Quality support for internal manufacturing processes as needed

• Participate in record review of executed production records for reagents and bulk drug substance lots.

• Perform release processes for materials at Spark, as well as current labelling verification and reconciliation of incoming materials and document control processes.

Education and Experience Requirements

• At least 2 years left of a combination of undergraduate and/or graduate coursework with summer availability (e.g., rising junior, or rising senior pursuing graduate school)
• Currently enrolled in an accredited college/university
• Majoring in a [STEM-related] degree
• Minimum availability of 10 weeks (about 2 and a half months)

Key Skills, Abilities, and Competencies

• Ability to multi-task and workin a regulated environment.
• Self-motivated and proactive in learning
• Demonstration of agile mindset
• Excellent verbal and written communication skills
• Willingness to lead
• Demonstrated interest in biotechnology and gene therapy industry

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.