Lead by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
Lead/conduct area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups
Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
Excellence
Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
Lead and facilitate operations readiness activities and programs for the DAP portion of the business which include consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows throughout the facility
Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
Understand and influence the manufacturing control strategy for their area
Develop, monitor, and propose solutions to improve or meet key performance indicators (KPI) for the area.
Respect for People
Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
Lead area tours to support business reviews, regulatory audits, or network collaboration.
Qualifications
Bachelor's degree in a STEM or pharmaceutical related field of study.
At least 2 years working within manufacturing/operations.
Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA, or other similar groups
Excellence in; electronic, written, and oral communication skills
Strong technical aptitude as demonstrated through previous work or educational accomplishments
