Manufacturing Production Specialist

1 week ago


Coppell, Texas, United States Fladger Assoc. Inc. Full time
Job Overview

Fladger Assoc. Inc. is seeking a dedicated Production Operator to join our dynamic manufacturing team. This role is essential in the production of high-quality active pharmaceutical ingredients, ensuring compliance with industry standards and operational excellence.

Key Responsibilities:
  • Engage in a variety of large-scale manufacturing tasks, including the precise weighing and dispensing of chemicals, conducting chemical reactions under controlled conditions, and overseeing the mixing, filtering, drying, and packaging processes.
  • Maintain ethical conduct and adherence to compliance protocols throughout all manufacturing activities.
  • Operate and monitor large-scale equipment, ensuring that raw materials are accurately measured and that batches meet quality specifications.
  • Conduct in-process testing as outlined in manufacturing documentation to guarantee product integrity.
  • Identify and report any equipment malfunctions or deviations from expected process outputs to supervisors.
  • Assist in troubleshooting equipment or process issues and propose effective solutions.
  • Uphold cleanliness and organization in manufacturing areas, which may include routine cleaning tasks.
  • Utilize electric and manual hand trucks for the safe movement and storage of chemicals and products.
  • Contribute to the development and revision of operational documents, such as standard operating procedures and batch records.
  • Participate in LEAN manufacturing initiatives to enhance efficiency and productivity.
  • Lead daily operational meetings as required and escalate issues to relevant departments.
  • Complete Overall Equipment Efficiency (OEE) reporting and review executed batch records.
  • Address training deficiencies promptly and maintain compliance with weekly and monthly manufacturing activities.
  • Engage in autonomous maintenance and conduct 5S audits as scheduled.
  • Perform regular audits of logbooks to ensure accuracy and compliance.
Qualifications:
  • High School Diploma or GED is required.
  • Mechanical aptitude with the ability to operate and perform minor maintenance on equipment.
  • Basic computer skills and familiarity with electronic equipment are essential.
  • Ability to follow both written and verbal instructions independently.
  • Proficiency in reading, writing, and understanding English is necessary.
  • Basic mathematical skills for performing calculations are required.
  • Physical capability to lift and move objects as needed.
  • Preferred qualifications include college coursework in science, experience in compounding, and a minimum of 2 years in a cGMP pharmaceutical environment.
  • Reliable attendance and flexibility to work various shifts, including weekends and overtime, are essential.


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