Actively participate as a team member on developing and documenting processes to mix, coat and manufacture pharmaceutical products. Team is responsible for successful design, development and commercialization of new pharma projects.
As a solutions driven team member, interpret FDA drug regulations and customer specifications to ensure requirements are incorporated into Tapemark specifications. Determine in-process controls required to assure process/product meet CQA’s and customer quality requirements. Responsible for qualification of processes, validation/verification of processes, and required documentation.
Utilize effective CAPA and Root Cause Analysis tools during investigation of Customer Complaints, material review reports, incidents, and other applicable non-conformances.
Support existing commercialized processes and improvement initiatives.
• Minimum Bachelor’s Degree in Engineering or science-based discipline and a minimum of 5 years Quality Engineering experience, preferably in the pharmaceutical industry supporting a research and development team.
• Excellent written communication including technical report writing
• Experience and comfort articulating and facilitating quality related discussions between client and project team.
• Ability to navigate ambiguity and multiple points of view to facilitate effective solutions to development regulatory challenges.
• Demonstrated successful application of quality by design tools, including DOE, FMEA, ANOVA, Gage R&R, and basic/advanced SPC, and tools.
• Ability to read, interpret, apply and communicate technical information, including drawings, statistical data and specifications.
• Knowledge and ability to understand manufacturing processes and implement quality standards, procedures, specifications and corrective actions that are effective and make good business sense.
• Knowledge of ISO 9001 and/or 13485, regulatory standards (cGMP, QSR) and Quality system standards, processes and procedures.
• Six-sigma black belt certification preferred.
Send resume to firstname.lastname@example.org.
Equal Opportunity Employer