This role participates in the day-to-day operations of the Flake Laboratory, with a primary responsibility to perform complex QA and Document Control functions in support of the preclinical studies under GLP-like conditions (Good Laboratory Practices), including record review and approval, reviewing and approving policies and procedures, assisting in planning, processing and investigating incidents and approving deviations, planning and corrective and preventative actions and change control, case report forms (nonclinical) review, reviewing and approving raw data, performing subject matter expert functions, and acting as delegate for Quality Director for approval of regulatory documents as assigned as described under job responsibilities.

Additionally, this role will be responsible for all Quality Assurance Unit (QAU) functions, such as, but not limited to: creating and maintaining a master study and audit schedule, monitoring all regulated study-specific and facility-related data/records/files via internal/external inspections and audit, creating and submitting status reports, assessing external vendors/subcontractor and representing GLP quality in internal/external discussions with sponsor.

This role is capable of leading in his/her area of responsibility, training of junior personnel, and conducts communication with clients and suppliers as relevant to job functions assigned.

This team member plays a vital role and helps assure that nonclinical studies comply with GLP standards to the extent possible. The position requires an exceptional attention to detail; thorough, accurate and timely documentation practices; management of a digital environment for vital equipment records, the ability to prioritize multiple job responsibilities and facilitate communication across interdisciplinary groups within the lab. This role works independently and self-directed, and is involved in personnel training as required.

• Performs routine QA functions including but not limited to material control, shipping and tracking of drug products and biological materials
• Performs technical review of records for clarity, correctness, and compliance with relevant SOPs
• Drafts policies and procedures
• Reviews policies and procedure
• Assist in planning, processing and investigating deviations
• Reviews and closes deviations and investigations
• Initiates incident reports and planned deviations
• Reviews incident reports and planned deviations
• Closes incident reports, planned deviations, and corrective and preventative action records
• Plans and participates in corrective and preventative actions and change implementation
• Approves corrective and preventative actions and change control documents
• Reviews batch production records
• Reviews QC test records and raw data
• Approves QC test records and raw data and defines final disposition of the material under test, excluding Final Product 
• Participates in hosting client and regulatory audits
• May perform subject matter expert functions as assigned commensurate with experience
• Act as delegate for Quality Director for approval of regulatory documents and clinical product release as assigned
• Trains junior personnel
• Conducts communication with clients and suppliers as relevant to job functions assigned
• Performs other duties as assigned