The Compliance Quality Assurance Associate will assist in the day-to-day operations of the Document and Records Management program, including the archival and scanning of Quality Records, and the Supplier Quality Management program, including assisting with completion of Supplier risk evaluations.
This individual will have a direct impact on the design, planning and execution of the improvements on the controls over Quality Records at Ocular.
DOC CONTROL SUPPORT (60%)
•Support with execution of a project to improve the control and use of space within the Document Control room, as well as archiving of documentation
•Creating logbooks and data request forms
•Scanning of quality systems documentation prior to archival
•Filing Quality Records in their designated areas
•Maintaining archive database for accuracy of documentation details and location
•Preparing and coordinating documentation transfer to offsite archive
SUPPLIER QUALITY SUPPORT (35%)
•Performing Supplier Risk Evaluations
•Conduct Supplier Follow-up for past due quality documents (e.g., Quality Agreements, ISO Certs, QA Questionnaires)
•Update Approved Supplier files (ISO Certifications; align hard copies with electronic Approved Supplier List, etc.)
MISC. RELATED TASKS (5%)
•Support other Quality related tasks as needed
•Able to take direction and work individually
•Proficient in Microsoft Word and Excel
•1-2 years’ experience working within Pharmaceutical / Biotech setting. Within Quality setting highly preferred.
•Life-sciences degree highly preferred