Lead, Soft Gel

Overview:

Under direct supervision of the production supervisor, the basic purpose of this position is to provide technical direction and leadership in assigned areas. Responsibilities will include troubleshooting product and process related issues, assigning work tasks, resolving employee issues, ensuring a safe workplace through proper training of the work force, maintaining compliance status and determining support group interventions as needed.

Responsibilities:

• Adheres to production schedules, assigning staff to ensure that production quotas are met for finished goods inventories
• Mentor, motivate and counsel associates, providing training and development to optimize their performance and personal growth
• Uphold regulatory requirements (GMPs, FDA, OSHA) and company technical requirements (SOP(s), Work Instructions, etc.) in the production of assigned product
• Participates and recommends improvements in machinery and equipment and in manufacturing methods for special projects and/or as opportunities arise
• Ensures that all GMP and safety standards are followed in compliance
• Oversee operating area(s) and responsible for converting raw materials into finished product in a safe, sanitary, cost-effective, and efficient manner that meets company quality standards
• Communicate to management progress of the department, problems, employee actions, new ideas, and all other relative information to the shift and department
• Communicates performance standards to associates, recognizing and rewarding individual and team accomplishments and counseling performance problems
• Interface with other department Team Leaders and employees in a professional manner to coordinate the activities and issues
• Serve as proxy for production supervisor(s) and assume responsibilities of other job functions as needed
• Supervise personnel and monitor equipment on assigned shift.
• Ensure all related soft gel department functions are carried out and that materials meet specifications.
• Training of employees on assigned shift.
• Operate all related Soft Gel equipment.
• Monitor all support equipment and adjust as required.
• Ensure flow of raw product.
• Order and complete all necessary batch record paperwork.
• Ensure that only quality products are made which meet all required specifications. Take disciplinary action whenever necessary.
• Knowledge and compliance of company policies and SOP’s.
• Knowledge and understanding of cGMP’s relating to this position.
• Other duties as assigned.
• Overtime as required.
• Identifies the temporary staffing needs of unit for the following day or week, and arrange for the presence and assignment of temporary or regular labor to the unit prior to line start-up
• Participates in GMP, sanitation and safety inspections throughout the production departments and corrects, or issues work orders to correct any identified deficiencies
• Adjust ingredients to machine runs in accordance to master batch record (MBRs) formulations
• Recommend and assist in authoring deviation request(s)
• Utilize company ERP system (AS400) for inventory transactions, scanning, label creation, verifying additions to batch records and data entry
• Utilize Microsoft Office Suite (Word, Excel and Outlook) to log production outputs, create product start-up documents to record relative standard deviations (RSDs), friability, disintegration, reliability/quality testing)
• May use (but not limited to) power equipment such as a forklift, hand tools, and other devices operated in a warehouse environment (i.e. electric jacks, sit down, stand ups, and cherry picker forklifts for applicable area(s)
• Always maintain clean work environment, including and not limited to hygiene practices
• Ensure rooms and equipment are properly cleaned and maintained and coordinate / perform all cleaning duties as required
• Ensure all inventory issues are monitored and resolved
• Interface with other departments as required (i.e. product development, maintenance, engineering, etc.)
• Maintain proper recording and usage of batch records per established compliance processes
• Ensure SOPs, work instructions and cGMP(s) are always followed
• Work overtime and perform other duties as required
• Ability to function effectively at both strategic and tactical levels
• Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others
• Strong change management skills to challenge the status quo and drive improvements
• High ethical standards
• Models and supports organization’s goals and values
• Leadership by example, “roll up the shirtsleeves” management style and work ethic
• Lead and coordinate 7+ manufacturing associates on each shift

Qualifications:

• High School Diploma or equivalent
• 2 years’ experience in a manufacturing operations role
• Proficiency in MS Office applications such as Excel, Word and Outlook
• Understanding of MAPICS, i5 production software or related AS400 systems
• Knowledge of FDA regulations, GMPs, sanitation processes and procedures and HAACP
• Understanding of production scheduling and other production variables such as run-rates, processing times, change-over times, etc.
• Demonstrated knowledge of efficient and safe manufacturing operations to include product and associate safety, OSHA standards, product quality (success rates), throughput delivery and cost control (minimizing downtime and waste, optimizing yield)
• Detailed oriented with good problem-solving skills
• Established evidence of leadership skills
• Demonstrated ability to execute work assignments autonomously
• Ability to maintain composure in stressful environment with sometimes conflicting priorities
• Ability to meet department deadlines