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PDS Tech Inc Manufacturing Operator (Trainee/Entry Level) in Fenton, Missouri

Manufacturing Operator (Trainee/Entry Level)

Job Description:

Ability to clean, set-up, and operate machinery in the oral solid dose area to manufacture product

meeting FDA and company standards of quality and productivity while adhering to applicable cGMPs and

SOPs including following written instructions and properly documenting the process.

Responsibilities:

  • Follow Master Batch Records for the manufacturing of controlled oral solid dose products.

  • Responsible for dispending and handling raw materials and product throughout manufacturing processes.

  • Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing equipment (oral solid dose manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulation, compression machines, etc.).

  • Perform in-process testing and inspections as required (use of balances, micrometers, etc.)

  • Cleaning and sanitization of manufacturing rooms including walls, floors, and ceilings per SOPs.

  • Follow good documentation practices.

  • Handling labeling and components correctly.

  • Maintain a neat and orderly work area.

  • Maintain documentation of log books and batch records while maintaining GDP.

  • Other duties as required.

Skills:

  • Ability to work in a regulated environment.

  • Capability to perform basic mathematical computations of addition, subtraction, multiplication, and division.

  • Strong attention to detail and ability to write and record data legibly and accurately.

  • Ability to understand and follow documentation (batch records, procedures, etc.)

  • Ability to work both independently and in a team environment.

  • Ability to operate various equipment (mechanical and computer interface).

  • Good interpersonal and communication skills.

Education/Experience:

  • High School Diploma or equivalent.

  • Minimum three (3) years pharmaceutical industry experience or equivalent experience in a similar regulated industry.

Requirements :

  • Ability to lift up to 35 pounds multiple times per day.

  • Ability to stand for long periods of time (8-10 hrs./day; 4-6 days/week)

  • Ability to read very small print.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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