Senior Quality Specialist – CQV 1 in Philadelphia, PA

Senior Quality Specialist - CQV 1 - Spark Therapeutics - Philadelphia, PA - work from home job Company: Spark Therapeutics Job description: 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 unlock the power of gene therapy to accelerate healthcare transformation. We don’t follow footsteps. We create the path. Job Title: Senior Quality Specialist-CQV Job Location: Philadelphia, PA Job Description: Responsible for providing Quality Assurance (QA) support for validation/qualification of equipment, systems, and manufacturing processes for the production of Gene Therapy drug substance and drug product. Provide QA oversight and guidance to project teams involved in the implementation of new equipment, computerized systems, facilities, utilities, and analytical instruments. Provide review and final approval of system lifecycle documentation related to implementation of production facilities, utilities, manufacturing systems and analytical laboratory equipment, including User Requirements Specifications (URS), Validation Plans, Qualification Protocols, Qualification Summary Reports, and Requirements Traceability Matrices. Assist in remediation of deviations, compliance gaps and requirements for changes to existing systems. Identify any compliance gaps within system lifecycle documentation and work with cross-functional colleagues to develop solutions. Attend project meetings and provide feedback and guidance for any issues associated with systems within the scope of responsibility. Provide input and QA approval for Change Controls, Deviations/Investigations and Corrective and Preventive Actions (CAPAs). Perform review and approval of test exceptions. Author, review, and revise standard operating procedures (SOPs), and other technical documents and reports used in the manufacture of clinical and commercial products. Requirements: Employer will also accept a Bachelor’s degree (or foreign equivalent) in Biochemistry, Chemical Engineering, Biomedical Engineering, Biology, or a closely related field, plus 6 years of experience. Experience must include 6 years: performing quality assurance oversight or validation in a Good Manufacturing Practices (GMP) manufacturing environment regulated by one of the following or a combination of FDA, EMA, or Health Canada; performing or providing Quality Assurance oversight for qualification or validation, which may include one of the following or a combination of GMP equipment, computerized systems, utilities, facilities, or analytical instruments, in accordance with current industry practices, regulatory authority expectations, or data integrity requirements for computerized systems. Must have 3 years: working with manufacturing equipment, computerized systems, or analytical instrumentation associated with the manufacture of Biologics or Gene Therapy drug substances or drug products; using Quality Management Systems, including one of the following or a combination of Change Control, Deviations/Investigations, or CAPA; creating, reviewing, or approving lifecycle documentation for GMP equipment and systems. Remote work available up to 2 days per week. Please send resume to, and reference:___3348 Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees. Senior Quality Specialist - CQV 1 - Spark Therapeutics - Philadelphia, PA - work from home job Expected salary: Location: Philadelphia, PA Senior Quality Specialist - CQV 1 - Spark Therapeutics - Philadelphia, PA - work from home job Job date: Fri, 25 Aug 2023 22:44:41 GMT Apply for the job now! Senior Quality Specialist - CQV 1 - Spark Therapeutics - Philadelphia, PA - work from home job Apply tot his job Apply tot his job Apply To this Job