Specialist, QA Release
QA
SAP
Documentation
SOPS
SOP
Description:
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
- Travel Required : No travel required
- Shift timings: Not specified