Specialist, QA Release

WillHire; Athens (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

WillHire is seeking a detail-oriented documentation review/approvals professional to ensure batch documentation compliance and to approve Certificates of Analysis and Certificates of Conformance for batch releases. The role includes SAP movement transactions, usage decisions, and second checks to guarantee quality and regulatory compliance.

Ideal candidates have a BS degree in a relevant science field and at least 2 years of related experience, with training completed by target dates.

Qualifications

• 2 years of relevant experience preferred.
• BS degree from an accredited institution in a relevant scientific discipline.

Responsibilities

• Prepare batch record documentation and review for compliance with Good Documentation Practices and SOPs.
• Resolve minor issues found during documentation review as directed by SOP.
• Resolve major issues that are not defined by SOP.
• Review and approve Certificates of Analysis and Certificates of Conformance for batch release.
• Perform movement transactions in SAP system of product as needed.
• Perform usage decisions for batch release in SAP.
• Perform second check in SAP prior to batch release.
• Complete all assigned training by target due dates as assigned by BIAH.
• 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.

Education

BS degree in a relevant scientific discipline

Tools

SAP

Job 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