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