Compounder Pharmaceutical Manufacturing

4 days ago

Largo, United States Formulated Solutions Full time

THE COMPANY:

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.


PRIMARY PURPOSE:

The scope of a Compounder is complex in scope performing in multiple compacities within the department. Major duty will be to precisely weigh and tag all pre-weigh materials. This is completed by computing simple math to Interpreting weights and measurements. Assisting others in the weigh out and mix exact amounts of chemicals according to specific formulas, calibrate, operate, and monitor all manufacturing equipment. Accurate formulation execution of production lots, set up, load, operate, and monitor compounding equipment. Assist Compounder II or above in performing duties as assigned. Duties are defined in Blending Batch Records and day-to-day activities as directed by Manufacturing Management.


It might be necessary to perform duties not mentioned in the Job Description (This is to include but not limited to):

  • Cleaning of parts, equipment or production rooms
  • Working on a Packaging Department line
  • Cleaning buckets, tanks, or ancillary equipment
  • Using floor scrubbing equipment
  • Any other duties management deems necessary to support company activities


MAJOR DUTIES AND RESPONSIBILITIES: (includes the following but not limited to)

General:

  • Understand and follow verbal instructions in English
  • Read, understand and follow written instructions in English
  • Notify if instructions appear to be incorrect or cannot be followed
  • Stop work until resolved or follow supervisory direction
  • Neatly and accurately record data per FDA Good Documentation Practices
  • Identify mistakes and immediately bring to the attention of supervision
  • Accurately count production or inventory items and neatly record results
  • Understand standards assigned to each job and work within those standards
  • Perform other duties as assigned
  • Must be able to wear a fitted full-face respirator or half respirator when required.


Assist Blenders with Blending operations:

  • Accurately blend product in amount and sequence and timing as shown in written instructions
  • Set-up scales for weighing product
  • Select English or metric units and tare weights per procedure
  • Accurately weigh product using in Metric or English units
  • Verify room/batch readiness and room clearance
  • Accurately identify and record raw material part numbers or names
  • Clean and use pre-mix containers as required
  • Apply labels to containers as required to identify product/blends


Assist Blenders with Machine Operations:

  • Assist with setting up lines and work areas prior to each blend:
  • Containers, labels, scales, instructions, data collection sheets, etc.
  • Complete batch set-up records
  • Assist with monitoring and performing machine adjustments during the blending process as required
  • Load blending tanks with material
  • Cover open tanks/containers and contamination as required to prevent contamination
  • Assist in cleaning tanks, blades, product delivery tubes/hoses, fillers, hoppers, tanks, nozzles, drums, etc.
  • Obtain QA acceptance that cleaning is acceptable prior to equipment use/storage as required by procedure
  • Assist in maintaining blending equipment and tools (adjustment/service/repair) in correct location


Quality:

  • Identify and understand quality criteria for task performance
  • Perform task in a manner that meets/exceeds quality criteria
  • Identify quality problems and cease operations until resolved
  • Resolve quality issues within blending area or seek support


Material handling:

  • Load/unload boxes of components, raw materials, etc.
  • Operate manual pallet jack
  • Control and maintain integrity of material stock quantities
  • Correctly record material withdrawals/changes on inventory cards and batch records
  • Load/unload 55-gal drums onto and off-of pallets and roll into correct place, using assistance if required
  • Understand how to operate safely in situations where exposure to potentially harmful chemicals may exist
  • Document inventory changes per procedure


QUALIFICATION:

A. Preferred

  • Multitask (must be able to organize and/or control multiple jobs and multiple machines)
  • Must have basic math skills to understand weights, blending/mixing formulas and to track production quantities.
  • Must be able to lift 50-70lbs on a regular basis.
  • Must have the ability to stand for long periods of time on a regular basis.


CRITICAL SKILLS AND ABILITIES:

  • Ability to operate blending/mixing/filling machinery and related equipment.
  • Ability to assist in diagnosis and repair of malfunctioning machines.
  • Ability to organize and control multiple jobs and multiple machines.
  • Ability to communicate effectively with personnel.
  • Ability to follow written/verbal instructions.
  • Ability to keep accurate records.


Education and/or Training

• High School diploma or equivalent

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