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QA Technician
Cuyahoga Falls
, Ohio Contract
Hybrid
QA Technician
Cuyahoga Falls, OH - Hybrid
QA Technician will serve as a primary person responsible for making decisions concerning the degree to which OTC/FDA/EPA products have been manufactured in accordance with the regulations, internal procedures, and customer requirements prior to release for distribution based upon a review of the records and processes.
QA Technician Responsibilities:
QA Technician Requirements:
Cuyahoga Falls, OH - Hybrid
QA Technician will serve as a primary person responsible for making decisions concerning the degree to which OTC/FDA/EPA products have been manufactured in accordance with the regulations, internal procedures, and customer requirements prior to release for distribution based upon a review of the records and processes.
QA Technician Responsibilities:
- Record review of production - both blending and packaging operations, both internal and from Contract Manufacturing Organizations
- Label verification
- Daily decision making on goods disposition (i.e. suitable for release and distribution)
- Completing and documenting Formula Reconciliation
- HALB and FERT stock postings (unrestricted, blocked, etc.)
- Review and verification of sampling, including micro, analytical, reserves, stability, and validation samples and results
- Generating Certificates of Analysis and Certificates of Manufacture
- Data integrity
- Quality Notification generation for non-compliant products/processes
- Generation, maintenance, and distribution of the daily hot list
- Communication and problem resolution with relevant parties (Operations, CMOs, QA Auditing, Dev. Mgmt, SC Management, etc.)
- Updating SLED dates in ERP
QA Technician Requirements:
- Experience in a manufacturing or highly regulated environment (FDA, EPA, cGMP, or ISO) strongly preferred.
- Microsoft Office Suite knowledge with ability to learn new software
- Auditing, decision-making, and problem resolution skills
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