Sr. QA Specialist

The Sr. QA Specialist will be responsible for providing oversight to external product and raw material/starting material (e.g. plasmids) manufacturing vendors and sites (CMOs) providing starting materials (plasmids), raw materials/buffer solutions, bulk drug substance, formulation, aseptic filling and packaging/labeling services for product intended for commercial and/or clinical distribution to ensure compliance with GMP's (US/EU/ROW).

Responsibilities

Serve as the Quality Assurance representative and point-of-contact between the site of manufacturing, the CMO vendor, and Spark.

Evaluate analytical results against approved specifications to determine compliance, release materials for use and/or provide an appropriate disposition for product. Prepare certificates of compliance (CoC) and/or certificates of analysis (CoA) for products for clinical and/or commercial materials.

Review and approve contract manufacturing Master Batch Records and executed batch record associated with contract manufacturing. This includes equipment qualification, media fill/process simulation, CCIT, filter validation and other container/closure and/or manufacturing process-related studies. • Assist with the preparation of regulatory documents, such as INDs, BLAs, CBE-30s, briefing documents, etc., as associated with 3rd party manufacturing and related activities.

Provide technical support (man-in-plant) during manufacturing activities

Collect and assist with the analysis of product manufacturing process data for the identification, classification, justification and maintenance of various operational parameters.

Other assigned responsibilities as established by QA CMO Lead

Education and Experience Requirements

BS / BA degree in business management, engineering or science discipline is required.

Generally, has 5+ years of relevant experience within the pharmaceutical/biotechnology industry

Must have proven experience working in a GMP environment and interaction with 3rd party representatives

Process and equipment experience and/or knowledge in the areas of biologic drug substance, aseptic fill, finish and packaging operations is required.

Experience with supply chain logistics and security measures is strongly preferred Direct experience with Regulatory Inspections is preferred Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines is required

The ability to travel approximately 30%, domestic and international Requirement to work some weekends and off hours, depending on project schedules

Key Skills, Abilities, and Competencies Possess the ability to multitask and work independently or in a team environment with moderate supervision Possess good interpersonal and strong written/verbal communication skills Well-developed skills in prioritizing, organization and time management Highly motivated and detail oriented with good organizational skills Understanding of statistical analysis methods

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.