Participate as member of Internal Audit team. Assist in scheduling, performing and reporting internal audits as well as supplier audits and related activities.
Assist with the development and implementation of corrective and preventive actions [CAPA’s].
Initiate and maintain SOP and protocol deviations.
Maintain and report monthly metrics for all aspects of quality systems.
Monitor equipment calibration program.
Assist in the QA review of data and reports.
Perform periodic reviews
Maintain integrity of QA document Portals on Share point
Develop and distribute controlled quality system documentation
Develop and maintain databases/spreadsheets for document control
Maintain filing and storage systems for document control, training and study records
Assist in new staff training
Participate in FDA and customer audits as needed
Provide back-up coverage for the Manager, QA and to other Quality Specialists (or team)
Carry out other duties/projects as assigned
Minimum of 3 years’ experience working in a Quality Department in a GLP setting, including internal and external audits and document control. Familiarity with regulatory needs for biologics and cell-based therapeutics.
Knowledge of root cause analysis, corrective/preventative actions and process improvement.
Skilled proficiency in use of Microsoft Office Word, Excel, Adobe Acrobat
Demonstrated highly developed communication skills including well developed writing skills and verbal and interpersonal skills.
Ability to organize tasks, work independently and adapt to changing priorities.
Ability to function in a minimally supervised environment with exceptional attention to detail required.
Must be able to read, write, speak fluently and comprehend the English language.