QA Documentation Specialist I

Job Title: QA Documentation Specialist I

Location: 14905 Kirby Drive Houston,TX -77047

Duration: 6+month

Shift:N ight shift (4pm-12am) Mon.-Fri (ONSITE)

Job Description:

Document Control, Document Issuance will be responsible for performing document control duties including issuance of controlled printed copies, logbooks, reference prints, as well as assisting with records archival and checkout, and assisting with the change request process for controlled documents (SOPs, Batch Records, and Forms, etc.) in an electronic documentation management system. Support other quality systems such as deviations, CAPAs, audits, change controls and training, as needed.

Issue production and testing documents as requested by manufacturing, validation and quality control departments

Issue LIMS labels and logbooks as requested by MFG and QC

Utilize Excel spreadsheets and other tracking software to input data used for quality tracking.

Perform records management tasks such as filing, scanning, archiving, logbook issuing

Responsible for assisting with the on-site and off-site document storage process for archiving and retrieving documentation

Support internal / external audits by copying, scanning and distributing various documents as needed

Ensures all aspects of work are completed within the allocated timeframes in line with changing business needs and project objectives and requirements.

Develop and implement process improvements.

Cross-train with other members of the Document Control group to serve as back up for other Document Control functions as needed, including eDocs and records management.

Perform other duties as assigned.