Production Machine Operator; Sterile Filling (Midnight Shift)

Manufacturing & Packaging Rochester, Michigan


Description

Job Description

 

Job Title

Sterile Fill Production Machine Operator

Company

Par Pharmaceutical

Function

Operations & Manufacturing

Location(s)

Rochester, MI

Department

Sterile Filling

Direct Reports (list)

N/A

Reports to (title)

Sr. Supervisor Sterile Filling

Date Submitted

5/9/2016

To be completed by Corporate Compensation:

Job Code

J03491-MW

FLSA  (USA only)

Non-Exempt               LG:  11-14

 

Job Summary - a concise overview of the job

In accordance with Current Good Manufacturing Practices, Standard Operating Procedures (written and/or oral) instructions and Safety Regulations are responsible for the continuity of complex operations required to maintain production.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Union job at Par Pharmaceutical, Rochester, Michigan manufacturing plant

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Operational

  • Sets-up, checks, adjusts and runs production equipment as required by product and size change over. This requires the PMO to bend, lift, use both hands and have correct 20/20 vision
  • Communicates effectively and on a timely basis to fill and seal operators
  • Coordinates with Area Supervisors to ensure an efficient filling operation
  • Communicates with Supervisor in a proactive manner with respect to line operating conditions, product quality status, and potential improvements
  • Cleans lubricates, starts, stops and services equipment necessary to promote and maintain a smooth & efficient flow of production
  • When necessary, performs required environmental and personnel monitoring sampling and recording
  • Determines and verifies that correct and adequate labels, materials and supplies have been provided to meet production schedules
  • Maintains a continuous supply of materials to production lines
  • Notifies Area Supervisor of processes or equipment not in a state of regulatory compliance when discovered

70%

Documentation

  • Documents all line clearance forms and other documentation forms necessary for the processing of each batch
  • Records downtime, production output and other manufacturing documents as assigned

10%

Compliance

  • Maintains eligibility for core qualification

10%

Testing

  • Integrity tests sterilizing filters

10%

Other

  • Performs other duties as assigned by Area Supervisor

Continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • High School Diploma, GED or equivalent
  • Successful completion of in-house training programs (includes Upgrader Exam)

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Arithmetic Aptitude preferred
  • Pressure and Temperature Aptitude preferred

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific      e.g. coaching, negotiation, calibration, technical writing etc.

  • Mechanical Aptitude preferred
  • Hand Tools and Measuring Instruments Aptitude preferred

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Required to reach with hands and arms and frequently required to use hands to finger, handle or feel
  • Occasionally lift and/or move up to 50 pounds
  • Specific vision abilities required by this job include close vision
  • Frequently exposed to moving mechanical parts
  • Frequently exposed to toxic or caustic chemicals 
  • The noise level is moderate
  • Work environment is a production/manufacturing environment

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

        

Customer Focus Results DrivenLeadership Teamwork Innovation and Continuous Improvement

 

Endo Job Description Template - Revised July 2014