QA Documentation Specialist - II*

Minimum Qualifications / Training

The QA Documentation Associate II has a minimum of a Grade 12 diploma with a minimum of 3 years of relevant experience and a working knowledge of computers including a proficiency in Microsoft Office applications. Familiarity with computerized systems, organized, willingness to learn required. Experience in a regulated industry preferred. BSc preferred.

Duties and Responsibilities

Scans, files and retrieves quality-related records (electronic and paper) that are maintained by the QA department. These records include, but are not restricted to batch records, packaging and labeling records, analytical test records for products, intermediates, raw materials and consumables, training records, environmental monitoring records, change control records, investigation reports and log books.

Issues required documentation (electronic and paper) such as batch records, methods, reports, protocols and forms accurately and in a timely manner.

Recalls copies of superseded documents, archives the master, and destroys the returned copies.

Ensures the quality and accuracy of all documents issued electronically and on paper.

Maintains distribution lists for all documents issued including batch records, reports and protocols through use of document tracking forms and regular maintenance in the electronic document management system.

Functions as the primary Gilead Alberta document coordinator for the electronic document management system.

Assists in the preparation and revision of specifications and Master Batch records (MBRs) in accordance with company policies, procedures and formats.

Provides clerical and administrative support related to documentation system requirements (e.g. EDMS, GPLM).

Enters, maintains and ensures the accuracy of information in applicable databases.

Participates in QA checks of the warehouse and manufacturing areas as scheduled.

Provides support for internal and regulatory audits/inspections as required.

Abides by all safety rules which apply to them, especially the emergency response and evacuation procedures and the Sign-in and Sign-out procedures. These rules and procedures are outlined in the Gilead Alberta Employee EH&S Handbook.

Maintains current documented training on all applicable Safety and Environmental SOPs, and follows these procedures.

Reports accidents, incidents or near misses.

Completes required Standard Operating Procedures (SOPs) training, as identified in the training syllabus, within two months of starting employment with Gilead Alberta and retrains every time there has been a significant revision. Additional specific SOP training may be required for specific tasks.

Follows all procedures as written.

Attends all required training sessions and obtains a passing score. Repeats training if a passing score is not obtained.