Specialist, QA Release

WillHire, Inc; Athens (GA); On-site; USD 60,000 - 80,000; Full time

Job summary

WillHire, Inc. is seeking a Documentation Review and Compliance professional in Athens, GA. The role focuses on preparing batch record documentation and ensuring compliance with established SOPs and standards.

The candidate will review Certificates of Analysis and Certificates of Conformance for batch release, perform SAP movement transactions, and participate in second checks prior to release. 2 years of relevant experience and a BS degree in a scientific discipline are preferred.

Qualifications

• 2 years of relevant experience preferred.

Responsibilities

• Prepares batch record documentation and ensures compliance with SOPs.
• Resolves documentation issues per SOP and notifies when guidance is needed.
• Reviews and approves Certificates of Analysis and Certificates of Conformance for batch release.
• Performs SAP movement transactions and second checks prior to batch release.
• Initiates non-conformance reports for serials/lots that do not meet requirements.
• Reviews specifications/standards/inspection plans for regulatory compliance.

Skills

Documentation review

SOP compliance

Batch release

Education

Bachelor's 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