Quality Assurance Specialist

About the role

This role supports Manufacturing, Supply Chain, and Clinical operations by reviewing batch production records and documents, inspecting and releasing raw materials and consumables, approving clinical labels and clinical material labeling batch records, and providing Quality input to Shiloh Glenn site start-up activities.

Responsibilities

• Provides timely Quality review and approval of clinical labels and executed clinical material labeling batch records.
• Provides Quality input to Shiloh Glenn start-up projects, including the frozen Drug Substance/Drug Product project and Electronic Batch Record implementation.
• Reviews and approves deviations, change controls, and CAPAs, ensuring investigations and corrective actions meet cGMP and Kriya quality standards.
• Authors and approves SOPs and other controlled documents supporting clinical labeling and Shiloh Glenn Quality systems.
• Participates in risk assessments and change control activities to support qualification of new materials during onboarding.
• Provides on-the-floor Quality support for Manufacturing Operations, reviews executed batch records, and disposes raw materials as Shiloh Glenn transitions to steady-state manufacturing.

Requirements

• Bachelor's degree in a scientific, engineering, or related discipline with 2+ years of cGMP Quality Assurance experience in biologics or pharmaceutical manufacturing, including direct experience with clinical labeling, batch record review, deviations, CAPAs, and change control.
• Demonstrated experience authoring and reviewing SOPs and other controlled documents.
• Experience supporting site start-up activities, material onboarding, or risk assessments preferred.
• Experience with electronic batch record (EBR) systems preferred.
• Experience with quality oversight of Fill Finish operations and Visual Inspection reviews is preferred but not required.

Skills

• Strong attention to detail and ability to work cross-functionally with Manufacturing, Supply Chain, and Regulatory teams.
• Ability to manage daily work activities of this role with minimal supervision.

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.
• Some lifting of equipment or materials may be required.
• Work may involve exposure to chemicals or biological materials; proper handling and disposal procedures must be followed.
• Must be able to don grade C and D level cleanroom gowning and work in a cleanroom environment.
• Must be willing to work outside of normal business hours, as necessary, to support the manufacturing process.