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