Overview
Quality Control Technician Jobs in Austin, TX at Abacus Service Corporation
Position Summary
This position supports the operational activities of the site through tasks associated with creation and maintenance of quality documentation.
These activities are based on written procedural requirements established both locally and at higher corporate authority.
Create, coordinate, implement, and archive Plant Change Orders, Standard Operating Procedures (SOPs), Batch Records (Work Orders), etc.
Maintain critical quality documentation related to Change Control, Validation system, including Installation Qualification and Operational Validations, and Engineering Change Requests.
Coordinate and implement all policies, procedures, and specifications received from Corporate that are applicable to the Austin Plant.
Maintain Documentation administration requirements related to all aspects of record management.
Essential Duties & Responsibilities
- Review and coordinate the creation, edit, and routing of change orders for new and revised Standard Operating Procedures, Work Instructions, Batch Records, etc. as requested for the Austin and Round Rock manufacturing sites.
- Create and issue Batch Record packages, using the Document Management System (DMS), to all appropriate operational areas within the Austin and Round Rock manufacturing sites, based on the plant manufacturing schedule(s).
- Maintain the documentation library including the issue, receipt and tracking of validation packages, batch records, logbooks, etc. maintained in the Documentation Storage Room.
- Perform administrative review of validation packages to ensure compliance with local SOPs.
- Perform administrative review of simple change orders / documents within the plant document management system to ensure compliance with local SOPs.
- Communicate with change initiators to ensure item content and the contents of the change package are correct and accurate.
- Perform administrative review of change control requests and track linkage to the documentation and validation changes.
- Adhere to cGMP’s, SOPs and plant policies / procedures.
- Actively participates in problem solving tasks that involve interaction with all plant disciplines.
- Ensures the timely creation and delivery of appropriate documents including schedule change requests and manufacturing, laboratory, and manufacturing quality work order requests.
- Implement approved change orders / documents within the plant document management system.
- Responsible for coordinating the logbook management process.
- Responsible for the receipt, review and distribution of all new and revised corporate policies, procedures, and specifications.
- Coordinate the biennial review process for controlled documents.
- Coordinates records management activities related to local and off-site storage of documents.
- Once established, may act as a Qualified Fellow Employee (QFE) or cross-train other individuals in their area of focus.
- Participate in department process improvement projects.
- Assist with the writing of Standard Operating Procedures.
- Perform other related duties as assigned or required.
Pay: $22.83 per hour
Work Location: In person
Title: Quality Control Technician
Company: Abacus Service Corporation
Location: Austin, TX
Category:
