Description

Core Hours: Monday - Friday 2:00pm - 10:30pm Purpose and Scope The Aseptic Supervisor performs activities related to supporting the injectable team, while ensuring that products are made with quality for our patients. Supervises and coordinates shift production activities and related staffing, scheduling and planning in manufacturing. Key Responsibilities Demonstrates a high degree of honesty, initiative, integrity, drive, reliability and trustworthiness. Actively models and fosters a positive, respectful, and harassment-free work environment for all employees. Actively supervises and manages the performance of hourly manufacturing employees in the aseptic manufacturing group. Conducts interviews and makes hiring decisions on hourly employees. Ensures open and transparent communication to the hourly employees about company priorities, policies and general company announcements. Identifies, proposes and sees through process improvements and optimizations of the aseptic manufacturing processes. Conducts employee performance evaluations Reviews and approves direct report timesheets. Communicates and sets daily production priorities with Process Leads and hourly employees. The Manufacturing Supervisor oversees the work of the Process Lead who conducts or coordinates the on-process training, including line orientation and risk review, of all new team members or those transferring. The Supervisor is responsible for monitoring the training progress and readiness to work independently of all direct reports. Ensures production team's adheres to all quality standards and specifications. Create, revise and implement Standard Operating Procedures (SOPs) and Production Batch Records. Performs Batch Record review, including prioritization, reviewing corrections, and following up to ensure timely completion. Perform Transactions in the Inventory Control Systems ERP (Enterprise Resource Planning) Systems. on a timely basis. Performs Investigations, and CAPA implantations for non-conforming events. Pre-approves expiration dates on batch records prior to manufacturing. Performs other related duties as assigned. Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities. Ability to stand for extended periods of time (up to 8 hours or more). Proficient in Microsoft Office (Excel, Word, Outlook). Excellent verbal and written communication skills. Ability to adhere to written production records and validation protocols. Strong understanding of basic math and writing skills to document production activities in batch records and/or log books. Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements. Capability to operate on a fast-paced manual assembly line using basic production equipment. Ability to legibly complete required documentation. Technical ability to assemble and disassemble filling equipment. Strong analytical and problem solving skills. Supports management's decisions and communicates change positively Maintains open and constructive dialogue with other leaders Take ownership for their responsibilities and their team's performance Creates a cadence of accountability for their team Ability to analyze and make decisions within time and schedule constraints Proactively and effectively manages performance Ability to quickly make decisions and understand the impact on processes and employees. Ability to lead by example and have a proven record of excellence in attendance, dependability and safety. Core Values The Production Supervisor - Aseptic is expected to operate within the framework of Tolmar's Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes. Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace. Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality. Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. Education & Experience High school diploma, GED or equivalent required. Bachelor's degree in scientific discipline or related field or equivalent experience preferred. 3 or more years of experience in a GMP manufacturing environment. Specific training in cGMP is desired Working Conditions Shift work in a manufacturing. May require overtime. Compensation and Benefits Annual pay range $83,000 - $88,000 depending on experience Shift differential 8%