Compounder

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 primary purpose of this position is to perform blending duties without direct supervision. Duties are defined in Blending Batch Records and day-to-day activities as directed by the Manufacturing Management.

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

• Working on a Packaging Department line
• Cleaning buckets, tanks, or ancillary 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.

Perform/Lead a Team in Blending Operations:

• Accurately weigh product using Metric or English units
• Understand how to convert English and Metric units
• Set-up scales for weighing product
• Select English or Metric units and tare weights per procedure
• Accurately blend product in amount and sequence and timing as shown in written instructions
• Verify line readiness and line 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
• Understand and operate a scanner
• Perform training of new employees

Perform Machine Operations:

• Set-up lines and work areas for blending prior to each blend:
• Containers, labels, scales, instructions, data collection sheets, etc.
• Complete and verify that Batch Records are present and
• Monitor and perform machine adjustments during operation as required
• Load blending tanks with material
• Cover open tanks/containers and contamination as required to prevent contamination
• Clean 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 the installation of new machines and equipment.
• Maintain blending equipment and adjustment/service/repair/tools 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
• Identify and properly correct missing steps, additional steps or any process changes
• required
• Document information in Batch Records, Cleaning Records, Engineering Studies, etc.
• Using Good Documentation Practices
• Maintain minimal errors with consistency
• Assist with Non-Conformances

Material Handling:

• Load/unload boxes of components, raw materials, etc.
• Operate manual pallet jacks
• Operate powered pallet jacks
• 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
• Operate Drum Lifts
• Train Blending I personnel to operate Drum Lifts
• Understand how to operate safely in situations where exposure to potentially harmful
• chemicals may exist
• Document inventory changes per procedure

Cross Training:

• Perform Pre-Weigh activities and responsibilities
• Working knowledge of Pre-Weigh scanners
• Understanding of the Process Flow for Pre-Weigh
• Proficient at proper weighing techniques
• Ability to demonstrate how to prep each raw material to be weighed
• Can review and audit Pre-Weigh records
• Regularly work in Pre-Weigh to keep up on process changes

QUALIFICATION:

A. Preferred (i.e. knowledge, prior 2-5 years experience)

• 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.

B. Preferred Additional

• Bachelor’s Degree

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.