Responsible for maintaining GMP quality standards, plant safety, and manufacturing productivity throughout the department. Requires in-depth knowledge and understanding of equipment to support set-ups, adjustments, repairs, and maintaining all equipment in accordance with diagrams, sketches, operation manuals, and manufacturer's specifications. Direct reports include all on-shift department staff.
Responsibilities
Specific Responsibilities
Monitors operators and equipment throughout each shift to ensure all SOPs are properly followed and executed. Coaches operators on proper operation and addresses violations with proper documentation. Directs machine operators and service personnel in details of daily schedule, operational goals and standard operating procedures and requirements. Ensures production schedule is maintained by making necessary corrections and adjustments to equipment to maintain maximum performance. Reports issues that may result in schedule not being maintained to management immediately. Oversees process parameters and makes changes by setting up assigned equipment for change in material, size, and product. Inspects and monitors equipment for quality of operation when changeover is completed. Routinely checks product for defects and imperfections. Examines finished product for conformity with quality specifications and records. Fosters a continuous improvement environment by evaluating and recommending on-going quality and efficiency improvements as it relates to process/engineering/formulation changes, machinery, documentation, machine utilization, and safety best practices. Assists with interviewing, selection, evaluating, promoting and dismissal of direct reports. Rewards, coaches and provides clear, meaningful and constructive feedback to direct reports to facilitate individual development. Appraises employees’ productivity, efficiency and performance for probationary reviews and annual merit reviews. Develops and maintains a capable, flexible, and motivated workforce by continuous education, cross-training, compliance training and maximizing employee effectiveness. Mentors Manufacturing Trainers, and Operation Specialists to help drive business performance. Communicates to all levels of the organization so that all employees understand company and departmental objectives and have clear expectations of performance. Evaluates machines/processes and utilizes root causes analysis to generate new ideas and creative solutions to improve utilization, effectiveness, and productivity rates. Promotes an environment of teamwork with all departments to ensure effective and efficient company operations. Responds to audit observations by correcting deficiencies and performing detailed CAPA analysis to prevent future occurrences. Promotes a safe work environment by ensuring proper and effective safety procedures are in place and enforced. Documents all safety incidents and near misses accurately and timely.
General Responsibilities
Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation. Requires regular attendance to perform essential element as contained herein between the assigned start and end times for work. Performs such individual assignments as management may direct. Other duties as assigned.
Qualifications
Education, Experience, and Licenses:
Associates degree or equivalent experience 1-3 years of experience in related field Experience in GMP environment (Preferably in Pharmaceutical Industry)
Knowledge, Skills, and Abilities
Strong team player and motivated problem solver. Clear and concise communication skills, both written and verbal. Proficiency in computer software applications: MS Word, Excel and PowerPoint. Ability to constructively interact with others to resolve issues and improve the operation. Continuous LEAN Six Sigma training (i.e. 5S) is highly desirable. Strong organizational, communication, and analytical skills. Team building skills and leadership qualities. Must maintain a positive attitude and a willingness to learn and develop skills. Ability to interact with other department Technicians, Schedulers, Product development and Information Services. The ability to work independently, within a production team and without supervision. Ability to work flexible work schedule. Job requires the ability to stand for long periods of time Requires the ability to lift 50 lbs.
International Vitamin Corporation (IVC) Is an Equal Opportunity Employer. Our organization remains steadfast in our commitment to fostering an inclusive and non-discriminatory work environment that welcomes individuals from all backgrounds. We firmly maintain the belief that every individual ought to be treated with respect and dignity, regardless of their race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, genetic information, or any other protected characteristic, as defined by the law. We pledge that all eligible job applicants shall receive an impartial and unbiased evaluation during the recruitment process, without any form of discrimination based on any of the protected class. Our dedication to promoting diversity and inclusivity remains unwavering, and we take immense pride in cultivating a workplace culture that values and celebrates differences. Our efforts towards creating an environment that is free from prejudice and discrimination are an integral part of our organizational philosophy, and we stand committed to upholding these principles.
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