Process OperatorSHIFT - MON-THURS 1PM - 11:30PM - START TRAINING ON 1ST SHIFT - MUST HAVES - LIFT 40 + LBS, ABLE TO WEAR AIR SUIT, SOME GMP PREFERRED, DEPENDABLE, BASIC MATH SKILLS. $3 SHIFT DIFF AFTER THEY CONVERT TO FULLTIME.The Process Operator micronizemills client provided material including both active pharmaceutical ingredients and excipients as per procedures and policies, client instructions and cGMP guidelines. Consistently models values and leadership behaviors in all interactions.• Operator I FunctionsPerform entry-level micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.Set up, operate equipment, and monitor production processes.Report production on batch records following good documentation procedures (GDPs).Work in a regulated environment with adherence to standard operating procedures and policies.Adhere to cGMP standards.Identify and communicate non-routine events, deviations, and GMP deficiencies to supervisor promptly.Clean the entire processing area and processing equipment.Produce thorough, clear, and consistent documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original, and Accurate).Demonstrate willingness to accept change, learn, and work with new processes.Stop and ask questions or suggest improvements when something is unclear.Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.This is a site-based position.Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.Measures of Performance:Adherence to safety and quality proceduresProduct quality, throughput and final yieldsExcellent attendance, punctuality, and dependabilityOperators' work ethic and general attitude as it pertains to the daily operations of the facilityPosition Requirements:Education or Equivalent: High School Diploma or GEDExperience:Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.Prior manufacturing experience and work in a regulated environment preferred.Ability to work weekday and weekend OT a plus.Knowledge/Skills Requirements:Communication Skills Oral and WrittenBasic Math Skills, interpretationPotential limited exposure to health & physically hazardous chemicals.Personal protective equipment, including gloves, a respirator hood, safety glasses, safety shoes and other Personal Protective Equipment is provided and is required to be worn in designated areas.Prior Production Experience preferredPhysical Requirements/Work Environment:Physical strength, stamina and dexterity while wearing fully enclosed air suiteEmployees be able to lift or move items up to 44 lbs.
(20kg) individually, or with a two-person lift between 45 lbs and 76 lbs. (35kg). 77 lbs and over with a lift assistance device.Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) as well as novel compounds of unknown potency and toxicityAbility to perform moderate physical labor including: lifting, climbing, bending, crouching, reaching and twistingAbility to stand or walk for up to 8 hours per day.Ability to climb steps/ladders and occasionally work from elevated platforms.Ability to wear a respirator hood and pass the required respiratory medical exam.Ability to work in loud environments and wear various types of hearing protectionAbility to work with chemicals, health/physical hazardous material safely and in compliance with the site safety programImportant Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom.
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