The Process Facilitator / Sr. Process Facilitator is the shift lead for the blending/filling/staging operation and is responsible for producing high quality product in accordance with regulatory requirements to achieve the operations production plan. This position identifies and implements opportunities for changes/improvements for the overall manufacturing process. The Process Facilitator provides training and development to the manufacturing coordinators and technicians. The Process Facilitator must maintain effective employee relations, compliance to cGMP and other regulatory requirements as well as environmental and safety obligations and company policies.
*Daily supervising and performing on -the-floor operations pertaining to manufacture in a
*Coaching Counselling, training /development discipline and recognition of direct staff, including performing annual performance reviews
*Generating Manufacturing SOPs, Wls, and MPRs
*Executing production and resource schedule against operational plan
*Final review of completed manufacturing documents per compliance and established timelines
*Investigating and Resolving problems, identifying root cause, and proposing process improvements through clear communication to senior management
*Interacting with outside vendors and senior management
*Participation and/or leadership role in multi-functional project teams, as necessary
*Participate in helping to evaluate and establish potential new interdepartmental procedures and practices
*Other duties as assigned and identified.
Position Requirements :
*Knowledge of cGMP and industry trends
*Detailed comprehension of good aseptic techniques in a clean room environment
*Minimum 2 years in cGMP environment. Experience working in a Lean Manufacturing environment.
*Bachelor Degree with at least 2 years experience in a cGMP environment
*Associate Degree with at least 5 years experience in a cGMP environment
*High School Diploma with at least 10 years experience in a cGMP environment.
*SAP, Trackwise, and Aegis experience preferred
*Familiarity with Optima INOVA a plus.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation.