Description:
Primary Duties And Responsibilities
- Develops and analyzes metrics and data that drive continuous improvement.
- Develops, improves, and maintains task, department, and general SOPs in accordance to cGMPs.
- Responsible for mentoring and training initiatives to improve workforce skill set.
- Leads 5S + Safety initiatives facility wide.
- Assists in the hiring and supports new operator onboarding process.
- May trouble shoot and repair packaging equipment.
- May assist with set ups, packaging duties and quality checks before, during and after packaging runs.
- Responsible for various record keeping activities including but not limited to batch records and shift reports.
- Competent in editing batch records and compiling constructive narrative information pertaining to batch production.
- People leadership skills and tools will be enhanced and developed through self-paced learning, such as assigned readings, seminars, formal training, and classes, as well as through an assigned mentor/coach.
- Completes accident/incident reports and conducts investigation. Participates in follow-up meetings and CAPA.
- Supports internal and external quality investigations.
- Will be responsible for daily operations within the department including, but not limited to, time management, payroll, PTO, and performance management.
- Initiates SOP/WI revisions as needed to assure compliance and continuous improvement.
- Performs related duties as assigned.
Experience And Requirements
- High School diploma or equivalent required. At least three (3) years of experience in a pharmaceutical production or manufacturing concepts, practices, and procedures preferred.
Minimum Skills, Knowledge And Ability Requirements
- Ability to lead and manage teams.
- Ability to read and understand the English language for the purpose of following instructions and instruction others.
- Ability to develop and maintain cooperative working relationships with others.
- Ability to use good judgment in order to carry out detailed instructions.
- Ability to work independently and lead others.
- Ability to handle a variety of tasks simultaneously.
- Good verbal and written communication skills.
- Attention to detail and intermediate skills with MS Office.
- Basic understanding of KPIs for manufacturing operations.
- Required to work various shifts, hours and weekends.