Documentation Review/Approvals: Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards. Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP. Resolves major issues that are not defined by SOP. Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release. SAP: Performs movement transactions in SAP system of product as needed. Performs usage decisions for batch release in SAP Performs second check in SAP prior to batch release. Training: Completes all assigned training by target due dates as assigned by BIAH. Inspection: Performs 2nd review/release approval of serials/lots. Initiates non-conformance reports for serials/lots that do not meet requirements. Routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements. 2 years of relevant experience preferred BS degree from an accredited institution in a relevant scientific discipline QUALIFICATION/LICENSURE Work Authorization : Green Card, US Citizen Preferred years of experience : 1 years Travel required : No travel required Shift timings :
Salary: $20.00 - $25.64 an hour
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