Job Description
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
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.
Job Tags
Immediate start,