This position is responsible for the general oversight and supervision of the ARx Facilities, Maintenance and Metrology consistent with cGMP for Pharmaceutical manufacturing under CFR211 guidelines.
Essential Functions:
Ensures that all ARx Maintenance and Metrology Associates perform their duties per procedure, per Good Manufacturing Practices, per Good Documentation Practices, and per ARx Safety Policy.
Coordinate and supervise maintenance and metrology associates to ensure core work is completed per ARx procedures, cGMP, DEA and CFR.211 requirements. Core work includes: PMs, Work Orders and Calibrations.
Review and approve PMs, WOs and Calibration records.
Organize, coordinate, prioritize and track outstanding issues and opportunities.
Coordinate and supervise maintenance and metrology associates to ensure support/improvement work is completed per ARx procedures, cGMP, DEA and CFR.211 requirements. Support/improvement work includes: Deviation investigations, Preventive Actions (PAs), Change Controls, MSOP / PMSOP Biennial reviews.
Review and approve deviations and PAs if not executed by self.
Initiate and manage facility / project related Change Controls.
Parato the maintenance and facility issues and formulate potential solutions for discussion with team and manager.
Coach and develop maintenance and metrology associates. Build the team as necessary.
Supply period metrics and updates to Director of Operations to include in period reports.
Represent Maintenance department in Change Control, Biennial Review and other meetings. Assign, execute tasks and track progress.
Provides coordination for and communication within and between all shifts, departments, and levels of the company.
Maintain work flow 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.
Analyzes and resolves work problems and coaches associates in resolving work problems.
Creates and revises Standard Operating Procedures and Standard Forms per ARx process.
Collaborates and contributes to the development of new products, processes, and equipment.
Lead the implementation and maintenance of LEAN 6S activities within the maintenance 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.
Ensures compliance with all relevant regulations (e.g. ISO, FDA, OSHA, EPA, DEP, etc.) and company procedures.
Additional Responsibilities:
Perform other duties and responsibilities, as assigned.
Job Specifications:
College degree (or equivalent) preferred; relevant experience with equipment and maintenance required.
Prior leadership experience (2 years) in a manufacturing environment required.
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 (operating procedures, protocols).
Ability to troubleshoot equipment and processes and identify corrective actions.
Ability to lead others in execution of 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.