ARx Production Supervisor- 3rd shift

Must be able to work 3rd shift hours, train on 1st. Job Summary: This position is responsible for the general supervision of the ARx Production operators and ARx production facilities consistent with cGMP for Pharmaceutical manufacturing under CFR211 guidelines. Essential Functions: * Ensures that all ARx operators adhere to all ARx Safety Policies including the appropriate usage of PPE according to the task being performed. Ensures adherence to Good Documentation Practices, Data Integrity Policies and all Gowning Policies in classified areas. * Responsible for all aspects of day-to-day operations including capacity planning, scheduling and schedule adherence, productivity, product quality and delivery performance assuring safe implementation thereof and compliance with all relevant regulations (e.g. ISO, FDA, OSHA, EPA, DEP, etc.) and company procedures. * Responsible for schedule adherence, target setting and ensuring appropriate escalation to reduce downtime by interacting with all appropriate departments to resolve problems that interfere with production requirements. * Provides communication within and between all shifts, departments, and levels of the company as needed. * Responsible for the execution of daily tier meetings to ensure engagement, communication, goal setting and KPI tracking for the Operations team. * Ensures that the ARx facilities are clean, controlled, and maintained appropriately per ARx procedures and GMP expectations. Reports issues to maintenance and coordinates repairs and PM work with the Maintenance and Facilities team. * Responsible to ensure all ARx operators are qualified on equipment manufacturing procedures and trained on batch records, MSRs, deviations and policies. Responsible to meet Operations training compliance of ≥90% with 100% training compliance on all executed processes. * Analyzes and resolves work problems and coaches associates in resolving work problems. * Completes investigations and deviations; assists in assigning root cause and the implementation of corrective and preventive actions (CAPA). * Supports Change Control procedures, ensures Operators are trained on all applicable change controls impacting production processes. * Creates and revises Standard Operating Procedures and Standard Forms as needed in the applicable document system for revisions. * Collaborates and contributes to the development of new products, processes, and equipment. * Ensure Controlled Substance security and that associated records are accurate and up to date. * Lead the implementation and maintenance of LEAN 6S activities within the production unit. * Completes performance assessments and ongoing coaching of operators, sets performance and development goals for Operators and fosters engagement across the teams. * Conducts disciplinary actions and performance improvement plans as needed to resolve ongoing performance issues. * As required, perform direct work, demonstrating ability to perform all of the various operations within the department according to documented procedures (QSOP, MSOP, MBR, etc.), protocols, deviations, and training lessons. Additional Responsibilities: Perform other duties and responsibilities, as assigned. Job Specifications: * College degree (or equivalent) preferred with 2 years' experience as a supervisor or lead operator in a manufacturing environment. 3+ years of cGMP experience in a leadership position, preferably supervisory, will be considered in lieu of a college degree. * Conducts activities with professionalism and treats all associates with respect. * Experience in a cGMP manufacturing environment preferred. * Possesses a good understanding of manufacturing operations/systems and related processes. * Requires the ability to work independently, with minimal supervision. * Possesses good written and verbal communication skills. * Ability to write SOPs (Standard Operating Procedures), Incidents, Deviations and Change Controls as needed. * Comprehend and follow written procedures (batch records, operating procedures, protocols). * Ability to troubleshoot equipment and processes to identify corrective actions. * Ability to lead others in execution of production tasks. * Ability to perform basic mathematical functions and apply basic statistical concepts such as mean (average). * Ability to work with numbers consistently and accurately; able to accurately read, calculate and document numbers repeatedly. Ability to calculate and round to required significant figures. * Ability to maintain flexibility in schedule and routine in response to fluctuations in inventory and production schedules and to re-organize the team to promote productivity and engagement. * Work environment involves moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, and irritant chemicals; will be required to use personal protective equipment such as masks, gowning, hairnets, gloves, safety glasses/goggles, shields, etc. * Physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching, or similar activities should be expected. * Knowledge of MS Word, MS Excel and MS SharePoint. Proficiency in MS Excel preferred. * Experience with Lean Principles and 6S preferred.

Created: 2025-01-27