Supervisor Production Aseptic (3rd Shift)

About the Role

The Aseptic Supervisor performs activities related to supporting the injectable team, ensuring that products are made with quality for our patients. Supervises and coordinates shift production activities and related staffing, scheduling, and planning in manufacturing.

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 implements 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.
• Oversees the work of the Process Lead who conducts or coordinates on-process training, including line orientation and risk review, of all new team members or those transferring. Monitors training progress and readiness to work independently of all direct reports.
• Ensures production team adheres to all quality standards and specifications.
• Creates, revises, and implements Standard Operating Procedures (SOPs) and Production Batch Records.
• Performs Batch Record review, including prioritization, reviewing corrections, and following up to ensure timely completion.
• Performs transactions in the Inventory Control Systems ERP (Enterprise Resource Planning) Systems on a timely basis.
• Performs investigations and CAPA implementations for non-conforming events.
• Pre-approves expiration dates on batch records prior to manufacturing.
• Performs other related duties as assigned.

Skills

• 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.
• Takes 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

• Center on People: We commit to support the well-being of our patients and treat 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 with an enterprise-wide mindset that lifts the whole organization.
• 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk-taking that drives better ways of working.
• 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.

Requirements

• 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 environment.
• Core hours: Wednesday - Saturday, 5:00 pm - 5:30 am (every other Wednesday off). Training hours may vary.
• May require overtime.

Pay

Annual pay range $88,000 - $100,000 depending on experience. Shift differential: 15%. Bonus eligible.

Benefits

Tolmar offers a strong benefits package. For more details, visit Tolmar Employee Benefits.