Description

Position and Scope

Essential Duties and Responsibilities

• Perform analytical testing of Asteria Health products to support finished goods product release.
• Perform analytical testing to support cleaning validation activities.
• Identify and document Out of Specification (OOS) events as related to laboratory testing. Initiate Corrective and Preventative actions (CAPA) and conduct effectiveness checks.
• Communicate any OOS results immediately and effectively across departments.
• Review laboratory standard operating procedures and conduct change controls to revise and improve documents as necessary.
• Assist in the dissolution testing program. This includes building a sampling schedule and submitting samples to a third-party laboratory in a timely manner.
• Assist in laboratory method transfer work and setup of laboratory space at the new Asteria Health site.
• Ability to identify and initiate continuous improvement projects in the laboratory.
• Sample incoming raw materials for routine and full compendial testing.
• Perform other Quality Control tasks as assigned by the Quality Unit, such as reviewing continuous room monitoring data.
• Ability to troubleshoot and maintain UHPLC instruments.
• Assist with inventory of laboratory consumables, spare parts and equipment.

Skills and Experience Required

• A four-year degree in the sciences, preferably with a Chemistry focus.
• At least three years (preferred) of practical experience in an analytical laboratory role.
• Experience working with cGMP guidelines and demonstrate expertise in a variety of the field’s concepts, practices, and procedures.
• Assumes responsibility for the accuracy of one’s work.
• Must exhibit excellent verbal and written communication skills.
• Must exhibit exceptional attention to detail.
• Multitasking skills and ability to meet deadlines in a fast-paced environment.
• Ability to work independently but in a team environment.
• Exceptional computer skills (data entry, Microsoft Office products, Adobe, eQMS).
• Excellent work ethic and reliability.

• Must be able to gown for ISO 8 area.
• Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.
• Must be able to use necessary equipment such as computers, scanners, phone/headset, or other technology devices as assigned.