Supervisor, Manufacturing - Tissue Section

Manufacturing Supervisors are responsible for overseeing the daily activities of their assigned team. This position is responsible for planning, scheduling and distributing work assignments for the manufacture of Werfen products, while meeting productivity standards, quality goals, and department objectives. Responsible for resolving operational and performance issues and recommending improvements to operations, processes and the work environment. Works closely with direct reports and other departments daily.

Communicates and collaborates with staff, department leadership, and other Werfen staff to meet goals and produce the highest quality products and services. Ensures all staff are meeting policies and administrative expectations. Activities are performed in accordance with standard operating procedures (SOPs), Quality Systems Regulations (QSRs), safety and administrative regulations.

This role is for our Tissue Section Department, second shift 1pm - 9:30pm

Key Accountabilities

• Supervises daily manufacturing activities carried out by the team/department, in compliance with Standard Operating Procedures (SOPs), and other quality systems requirements, which may include, but is not limited to:
  • Preparation of bulks and solutions.
  • Evaluation of raw materials, in-process materials, and finished reagents.
  • Development and compliance to master validation plans and ensuring applicable process and equipment validation protocols are developed, executed and maintained, as applicable.
  • Maintenance and review of laboratory notebooks and and/or any associated documentation for manufacturing, evaluation and development activities.
  • Research and correction of production issues.
  • Set-up, calibration, validation, operation, cleaning and maintenance of laboratory equipment, as applicable.
  • Creation, approval and implementation of Engineering Change Orders (ECOs) for manufacturing documents and SOPs.
• Monitors operations to identify, evaluate and implement operational changes to improve performance, service, productivity, costs, etc.
• Works with staff to assign tasks, answer questions, make decisions and resolve issues as they occur to ensure smooth daily operations.
• Plans and monitors the flow of work into and through the team/department to ensure adequate materials and resources to meet productivity, quality and service expectations.
• Trains and communicates with direct reports to ensure expectations are clear and staff comply with Quality Systems and administrative policies and guidelines.
• Ensures all required documentation is completed, in accordance with Quality Systems Regulations (QSRs).
• Investigates, analyzes and carries out corrective actions to maximize product performance or to resolve manufacturing problems, under the direction of department management.
• Writes and revises SOPs. Responsible for Engineering Change Orders (ECOs), for department documents, SOPs, Work Instructions and other Quality Systems documents.
• Communicates and collaborates with other departments, people managers and staff to ensure smooth and efficient operations.
• Assists with staffing decisions to ensure a high performing team; including interviewing, selecting, training and developing staff.
• Manages department schedules to ensure department goals are achieved; responsible for approving schedules, time off, overtime, and timekeeping reporting.
• Carries out performance management and development activities, including setting expectations, and providing meaningful feedback. Provides opportunities for development, where possible. Proactively manages employee relations issues; uses judgement in consulting with department leadership and Human Resources.
• Maintains regular and transparent communications throughout department through effective use of one-on-one meetings, team meetings and other forms of formal and informal communications.
• Responsible for staff training, to ensure competency. Ensures staff compliance to training requirements.
• Educates and supervises staff to ensure compliance with applicable Werfen SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
• Reflects the company values and serves as a role model to staff and customers.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Supports department budget indirectly by managing expenses…