This position is responsible for the safe and effective operation of assorted multi-function pharmaceutical packaging machinery in addition to the proper assembly of clinical supplies following the batch paperwork. The machine operator is required to follow all applicable standard operating procedures and supervisory instructions to ensure compliance with customer specifications and cGMPS’s. This position requires a full understanding of all phases of clinical packaging and the ability to perform all required operations.
Essential Duties and Responsibilities:
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Reviews batch paperwork and follows supervisor instructions to understand and perform the necessary packaging procedures required for assembly of each study.
- Cleans packaging rooms and machinery in accordance to Standard Operating Procedures and Good Manufacturing Principles.
- Performs manual and automated filling and packaging of blistered and bottled pharmaceutical products independently and approves in-process products at other stations.
- Performs and ensures proper card and drug placement using various secondary card sealing machinery.
- Accepts or rejects in-process clinical supplies according to acceptability standards determined by Good Manufacturing Principles, customer requirements, and Standard Operating Procedures.
- Labels and assembles both blinded (following a randomization schedule) and open clinical supplies in conjunction with other FCS personnel ensuring proper label placement and proper documentation of labeling activities.
- Accurately counts out and prepares packaging supplies to ensure proper accountabilities prior to and at the completion of a job order. Assists Quality Assurance personnel, Production Supervisors and Line Leaders in staging and reconciliation of components as required.
- Performs final check of work in-process and finished products and then packs these goods into appropriately labeled containers.
- Starts, stops, and operates packaging machinery that blisters, fills, wraps, labels, or packs pharmaceutical products.
- Observes machinery to detect malfunctions and ensure the safe and effective operation of packaging machinery in accordance with our SOP’s, GMP’s, and customer specified instructions.
- Performs several in-process adjustments to the machines that include but are not limited to: roll changes, pen changes, Teflon changes, various simple machine adjustments, assembly and disassembly of various machinery, reloading of components into auto-fed machinery, blow-outs, simple alignment functions, resetting of pre-programmed electronic counters, and the signing of machine logs for the cleaning and/or set-up of on-going jobs.
- Conducts all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
Basic Minimum Qualifications (BMQ):
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
Education/ Experience (BMQ):
High school diploma, or GED, combined with the ability to read, write and complete basic mathematics calculations. Minimum of 2-years experience in packaging or production-type setting.
Certificates and/ or Licenses (BMQ):
Internal and External Contacts:
Ability and/or Skills (BMQ):
This position requires hand-eye coordination, manual and finger dexterity, and an attention to detail. The ability to communicate machine operations to the supervisors, quality assurance personnel, maintenance mechanics, and other packaging personnel is required, in addition to a good mechanical aptitude.
___AM to ___PM core hours, additional hours as required.
Dexterity and ability to perform limited packaging operations. Long periods of standing while working in rooms. The physical ability to lift and load up to 50 pounds of materials onto a machine.
This position description is written as a guideline to inform Thermo Fisher Scientific Employees of what is generally expected of them at each job level. The description is not intended to be all encompassing or limiting in any manner; rather, it is hoped it will add understanding and better reflect the work performed at all levels of employment within Thermo Fisher Scientific. Duties and responsibilities other than those listed may be included as needed within the work group or the company as a whole.
The above information is for exclusive use within Thermo Fisher Scientific and may not be used or duplicated by others without written consent.
Position Description and Essential Job Functions
Please read and sign after reviewing the Position Description and Essential Job Functions for ____________________________.
I have the ability to perform the essential functions of this position with or without reasonable accommodation.
Printed Name: __________________________________________
Thermo Fisher Scientific - 17 months ago
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