Entry Production Operator

Grand Haven, MI

POSITION: Entry Production Operator

CLASSIFICATION: Hourly / Non-Exempt

DEPARTMENT: Production

REPORTS TO: Production Team Leader

Effective Date:  April 11, 2016

 

Summary of Responsibilities: The Entry Production Operator is responsible for performing daily tasks as directed by the Production Team Leader and/or Sr. Production Operator.

 

EDUCATIONAL REQUIREMENTS:

 

Minimum of a high school diploma or GED, some college a plus and/or minimum 3 years equivalent work experience within either the pharmaceutical/food industry or a manufacturing environment.  Must have demonstrated experience with quality /safety systems in a manufacturing environment as well as exposure to normal process manufacturing activities like teamwork, shiftwork, etc.  Experience in a GMP or FDA regulated facility is a plus.

 

REQUIRED SKILLS:

 

  • Average to above average mathematical skills (decimals, metric system, rounding, basic arithmetic)
  • Possess decision-making and judgment ability with regard to safety to self and others
  • Ability to focus on procedures for:
  • O.T.O (Lockout Tagout)
  • Confined Space Entry
  • Fall Protection
  • Forklift Safety (as a pedestrian and as a driver)
  • Understand meaning of process parameters
  • Understand meaning of in-process testing
  • Working around microbiologically sensitive areas
  • Ability to maintain attention around rotating, pinching, crushing equipment
  • Ability to maintain attention around high temperature and pressure air and liquid
  • Ability to work independently for extended periods
  • Ability to communicate via conversation, radio, and visually in emergency situations
  • Attention to detail
  • Ability to manage multiple priorities

 

GENERAL RESPONSIBILITIES:

 

  1. Have regular attendance;
  2. Work as an assistant while training on processes and demonstrate proficiency to operate and control processes on which training has occurred;
  3. Read and understand batch records and applicable SOP’s before starting any process;
  4. Comply with all cGMP requirements as directed by the Quality department;
  5. Physical requirements involve:
    - Occasional lifting up to 50#
    - Rolling product and raw material drums

- See PHYSICAL REQUIREMENTS addendum for full description

- Ability to work at height

  1. Have a working knowledge of scales, calibrations, and accuracy requirements;
  2. Maintain thorough, accurate, and legible documentation required fulfilling the cGMP requirement for the plant;
  3. Be accountable for all documentation and production, which is his/her responsibility;
  4. Alert the team leader to safety, quality, and equipment problems;
  5. Have a basic understanding of materials handling to prevent contamination and to comply with cGMP’s and customer requirements.
  6. Obtain in-process product samples, when necessary, using proper sampling procedures;
  7. Work and follow all safety procedures at all times and report any potential safety hazards to on-site safety staff or to team leader;
  8. Attend any occasional mandated Company meetings related to site operations;
  9. Other duties as assigned.

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