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
Required Education: Bachelor’s degree
Five (5) years of quality assurance experience.
One (1) year of managerial or supervisory experience.
Additional Salary Information: N/A
Internal Number: 90971
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