- Safety-conscious individual comfortable lifting, pushing and pulling material weighing up to 50 pounds. Dedicated to producing products of consistent quality. Excellent time management, organizational and written and verbal communication skills.
- Team-oriented leader with proven leadership and motivational skills successful in helping group members achieve business goals. Respectful and clear communicator focused on enhancing teamwork and collaboratively addressing challenges with logical approaches. Skilled in building relationships and enhancing employee satisfaction to drive work performance.
- Coordinates the bulk manufacturing activities to support the filling and packaging operations to enable the site to meet customer requirements.
- Maintains production in an orderly manner and maintains a safe, orderly work place for subordinates.
adheres strictly to all cGMPs, PPGs, and safety procedures to ensure the quality and integrity of products and safety of employees.
- Keeps working area in a clean and orderly condition according to PPG's and 5S principles.
- Par of new product introductions and coordinates the activities associated with new products, from formulation, manufacturing and cleaning of the various equipment.
- Investigates and troubleshoots all routine problems during normal activities. Knows how and when to apply or modify techniques to obtain best results. Designs and carry out a series of tasks to solve a problem independently/or with a team. Solutions may involve the formulation of new techniques and procedures. Displays initiative and commitment. Uses my expanded practical experiences to handle and troubleshoot complex problems. Provides troubleshooting support to junior staff members and assistance to senior team members on more complex projects.
- Perform the duties of the Senior Bulk Technician when its necessary.
- Ability to perform mathematical calculations, i.e., conversions volume to weight, English to metrics, yields, and specific gravity.
- Reports all accidents, incidents and near misses to management immediately.
- Actively participates in team activities including continuous improvement efforts, cost reduction initiatives and process improvements.
- Can actively communicate with other departments, i.e., Quality Assurance, Packaging, Technology, Research and Development, Maintenance, Pharmacy and Engineering.
- Makes suggestions for processing effectiveness/efficiency to Technology and/or R&D during demonstration/validation activities.
- Maintaining training on all equipment used including; set-up, operation, troubleshooting & shutdown, and PPG's, batch record and documentation requirements, proper formulations and sampling techniques.
- Assists in the training of new employees.
- Responsible for the supervision of Manufacturing and Packaging personnel in the PPU and the efficient and proper processing operations in theses sections. This includes the maintenance of the weekly manufacturing and packaging production schedules.
- Assume multiple roles in the PPU including assignments in multiple area and/or shifts. Supervises assigned personnel.
- Assumes responsibility for development of other exempt employees in the PPU. Assesses strength and weaknesses and conducts performance reviews and development plans accordingly.
- Assesses exempt employee performance and develops future plans accordingly.
- Assumes responsibilities for decision making in absence of Production Manager.
- Provides general supervision daily.
- Majority of tasks performed independently.
- Project/Day-to-Day work updates, schedule modification.
- Quality Situations
- Raw Materials Components
- Plant/Personnel Security
- Ability to dissect unanticipated manufacturing and packaging production discrepancies and resolved to maintain product integrity.
- Develop interpersonal skills with Production Planner Manufacturing.
- Planning daily and weekly requirements and long-term processing modifications including new equipment installation and new projects.
- Identify complex problems and reviewing related information to develop and evaluate options and implements solutions. Find ways to structure or classify multiples pieces of information. Plan, prioritize, allocate resources, and anticipate obstacles.
- Identify the problem, communicate the problem to the appropiate personnel, and analyze the problem using team-building skills to choose a solution.
- Through experience and broad operational knowledege, can provide guidance and insight to junior members of operational and support staff.
- Must provide direction to factory on a consistent basis the needs to comply with Federal and State regulations in regards to product integrity, product quality, environmental, and safety requirements.
- Computer/Technical Literacy
- Microsoft Office-Word, PowerPoint & Excel
- Organizational Skills
- Team Work Oriented
- Management Abilities
- Must able to lead a team in the execution of manufacturing batch record, weighing of materials and the cleaning of the equipment
- Must be able to read, demonstrate math ability and understanding, ability to visually verify steps in process, possess good eye/hand coordination
- Must show an ability and understanding of pharmaceutical batching and understand formulation procedures
- Participate in self-directed work team environment
- Problem solving and decision making sessions and working to improve performance measures
- Ability to use forklift, mixing equipment, filtering equipment, compounding tanks and pumps and scales and accurately operate a computer and any Enterprise system
- Lift up to 50 lbs- Exposure to raw materials (PAI's), which require the use of personal protective equipment