JOB SUMMARY
This position implements the production strategy and, through leadership and technical support, ensures work meets or exceeds standards. Oversees, directs and coordinates activities for all Manufacturing and Packaging areas, by performing duties or delegating. A strong on-the-floor presence is expected to maintain, monitor, and improve performance.
ESSENTIAL JOB FUNCTIONS
- Directs and coordinates production activities and ensures products are manufactured/packaged on schedule and within quality, safety, and cost standards.
- Monitors data, identifies opportunities and works with others to improve performance.
- Develops staffing strategies to meet current and future department needs. Monitors training and provides development opportunities to staff.
- Participates in the study of new investments or modification of production equipment
- Ensures compliance with company policies and addresses performance issues appropriately and promptly.
- Reviews and approves required technical documentation for department including, but not limited to, Standard Operating Procedures, Root Cause/CAPA investigations, and qualification/validation protocols. Authors/contributes to documents and reports as necessary.
- Provides leadership to department cGMP, regulatory and safety compliance efforts, monitoring performance and ensuring the delivery of appropriate training and direction.
- Establishes a culture of continuous improvement and guarantee its sustainability.
COMPETENCIES
- Teamwork- balances team and individual activities.
- Leadership- exhibits confidence in self and others and has the knowledge of when to delegate
- Strategic thinking- adapts strategy to changing conditions.
- Design- generates creative solutions, demonstrates attention to detail.
- Continuous Improvement- assess, monitor, and enhance processes to impact business performance.
- Problem solving- identifies and resolves problems in a timely manner, leveraging scientific analysis in decision-making process.
- Uses reason even when dealing with emotional topics.
- Knowledge and skills- shares expertise with others.
- Communication- speaks and writes clearly, informatively, and persuasively in positive and negative situations.
- Visionary leadership- inspires respect and trust.
- Change management- communicates changes effectively.
- Cost consciousness- develops and implements cost saving measures.
- Diversity and Ethics- promotes a harassment free environment and treats people with respect.
- Organizational support- follows policy and procedures, and upholds organizational values.
- Motivation- measures self against a standard of excellence.
- Professionalism- approaches others in a tactful manner.
- Quantity and Quality- completes tasks in a timely manner with organizational standards in mind.
- Safety and Security- observes safety and security procedures.
- Adaptability- adapts to changes in the work environment.
- Attendance- Is consistently at work and on time.
- Dependability- follows instructions, responds to management direction, works hours as needed.
- Initiative- asks for and offers help when needed.
SUPERVISORY RESPONSIBILITY
- Directly supervises and coaches management staff with overall responsibility for all full-time and part-time employees in the production department. Carries out supervisory responsibilities per PSI policies, current laws and cGMP’s. Trains, rewards and disciplines employees. Addresses complaints and resolves problems while taking responsibilities for others actions.
WORK ENVIRONMENT
- This job operates in a professional manufacturing environment. The role routinely uses standard manufacturing equipment such as mixers, heating and cooling vessels, pumps, scales, tube fillers, fill lines, conveyors, computers, phones, photocopiers, scanner, filing cabinets, fax machines and other misc. equipment. The noise level in the work environment is usually moderate. The employee is occasionally exposed to fumes and airborne particles. The employee may also be exposed to mechanical moving parts and high heat.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential function of this job.
- The employee is occasionally required to sit; stoop, kneel, crouch or stand for periods of time. The employee must occasionally lift and/or move up to 25 pounds.
USUAL WORKING HOURS
Monday – Friday, 7:00 a.m. to 5:00 p.m.
Capability to work extended hours if necessary.
TRAVEL
- This position may be required to travel for educational purposes and equipment purchases, as necessary.
REQUIRED EDUCATION/EXPERIENCE
- Bachelor’s degree, preferably in engineering, business management or related technical field. A combination of additional relevant experience will be considered.
- A minimum of seven (7) years of experience with increasing responsibility in manufacturing and operations experience is required. Management experience is required.
- A minimum of three years of experience in a cGMP or regulated environment is required.
- Lean training and experience developing systems and applying tools.
EEO STATEMENT
PSI does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
OTHER DUTIES
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities and activities may change at any time with or without notice