ARx Production Supervisor-2nd Shift

ARx Pharma; Glen Rock (York County); On-site; USD 70,000 - 100,000; Full time

Job summary

ARx Pharma in Glen Rock, United States invites applications for a supervisor role overseeing the ARx Production team. You will supervise operators and facilities to ensure cGMP and CFR211 compliance and coordinate daily activities to meet the production schedule.

Responsibilities include maintaining safety, quality, and documentation, coaching staff, conducting investigations and CAPAs, and supporting lean initiatives such as 6S.

Qualifications

• College degree (or equivalent) preferred with 2 years experience as a supervisor or lead operator in a manufacturing environment.
• Experience in a cGMP manufacturing environment preferred.
• Possesses good written and verbal communication skills.
• Ability to write SOPs and follow batch records, deviations, and training materials.

Responsibilities

• Oversee day-to-day operations of ARx Production operators and facilities to ensure cGMP and CFR211 compliance.
• Coordinate capacity planning, scheduling, inventory, and resource allocation to meet production goals.
• Lead and coach operators; perform investigations and CAPAs as needed; support Change Control and LEAN 6S initiatives.
• Ensure safety, quality, and proper documentation across shifts and departments.

Job description

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.

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 perform their duties per procedure, per Good Manufacturing Practices, per Good Documentation Practices, and per ARx Safety Policy.
• Responsible for all aspects of day-to-day operations including capacity planning, scheduling, inventory, resource allocation yields, 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.
• Directs the daily tasks of the operators in the ARx production facilities in order to execute the production schedule.
• Reviews production schedules and interacts with all appropriate departments to resolve problems that interfere with production requirements.
• Provides coordination for and communication within and between all shifts, departments, and levels of the company.
• Maintain workflow and ensure availability and use of proper materials and tools.
• Ensures that the ARx facilities are clean, controlled, and maintained appropriately per ARx procedures and GMP expectations. Reports issues to maintenance and coordinates repairs thereof with Maintenance.
• Responsible to ensure all ARx operators are qualified on equipment manufacturing procedures and trained on batch records, deviations and policies.
• 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.
• Creates and revises Standard Operating Procedures and Standard Forms per Universal Content Management (UCM) process.
• Collaborates and contributes to the development of new products, processes, and equipment.
• Support the security system, by monitoring access points to buildings and grounds and accessing the computer, as required.
• 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 on going coaching of operators.
• Conducts disciplinary action and completes proficiency plans for improvement.
• 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.
• 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).
• Comprehend and follow written procedures (batch records, operating procedures, protocols).
• Ability to troubleshoot equipment and processes and identify corrective actions.
• Ability to lead others in execution of production tasks.
• Ability to recognize situations requiring PPE and wear proper PPE for extended periods of time. Minimally safety glasses, sleeve covers, and gloves. At times, uses of additional PPE including masks covering mouth and nose for extended periods of time are required.
• 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.
• 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.
• Experience with Lean Principles preferred.