QA Floor Support / Room Release Specialist

Intellectt INC

Job Title: QA Floor Support / Room Release Specialist
Location: RTP, NC
Duration: 06+ month

Job Description:

Scope: Provide onsite QA support during manufacturing, including batch record review in parallel with production, room release, and related documentation review.

Key Responsibilities:

QA Floor Support: Provide real-time quality support to Manufacturing Operations, identify issues, and coordinate appropriate escalation and resolution.
Concurrent Batch Record Review: Review executed entries while production is underway to identify missing information, documentation errors, and discrepancies requiring attention.
Room Release: Perform assigned room-readiness checks and review required documentation in accordance with site procedures.
Logbook Review: Review applicable room and equipment logbooks for completeness, accuracy, and consistency with manufacturing activities.
Documentation Corrections: Coordinate timely corrections with responsible personnel using approved documentation practices.
Deviation Support: Capture factual information about manufacturing events and provide supporting records to investigation personnel.

Target Background:

Manufacturing QA: Direct pharmaceutical manufacturing experience providing QA floor support.

Room Release: Experience with room release or related manufacturing readiness and clearance activities.

Record Review: Hands-on experience reviewing batch records and manufacturing logbooks.

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Vacancy posted 1 day ago

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