COMPOUNDER II - 2nd SHIFT

FORMULATED Solutions LLC•Largo, FL

1d•Onsite

About The Position

PRIMARY PURPOSE: The primary function of this role is to assist a Compounder II or higher in executing blending and compounding operations in a regulated OTC pharmaceutical environment. Responsibilities include equipment staging, cleaning, material handling, and documentation — all performed in strict accordance with cGMP, FDA regulations, and internal SOPs to ensure consistent product quality and regulatory compliance. MAJOR DUTIES AND RESPONSIBILITIES: Strictly adhere to all current Good Manufacturing Practices (cGMP), FDA 21 CFR Part 211 requirements, company SOPs, and safety protocols to ensure a compliant, safe, and controlled production environment. Perform and document all cleaning, sanitization, and preparation activities in accordance with approved Batch Records, SOPs, and GDP (Good Documentation Practices). Immediately report any discrepancies, unclear instructions, or deviations to Compounding Supervision or Engineering for resolution. Maintain a clean, organized, and audit-ready work area at all times to ensure contamination control and inspection readiness. Participate in 5S programs and continuous improvement initiatives to support production efficiency, equipment readiness, and workflow standardization. Provide day-to-day operational support to the Compounding and Production teams, ensuring timely execution of production goals. Use NetSuite and RFSmart to: Perform inventory transactions including transfers, consumptions, and completions. Verify expiration and retest dates of raw materials before use. Generate and apply appropriate identification labels for traceability and batch compliance. Assist with setup and staging of equipment such as scales, homogenizers, blending tanks, pumps, and hoses according to batch record instructions. Record all processing parameters (e.g., weights, volumes, temperatures) in batch documentation with precision and in compliance with GDP. Perform material charging to blending vessels per batch record instructions, ensuring prevention of cross-contamination or material mix-ups. Execute line clearance and cleaning procedures between batches (lot-to-lot or full clean), including breakdown and cleaning of all required equipment as per validated procedures. Safely operate manual and electric pallet jacks to transport raw materials, equipment, stainless steel totes, and production containers within GMP areas. Demonstrate and promote a Quality First Mindset: Understand critical quality attributes and process parameters associated with compounding operations. Identify and immediately escalate any quality issues to Supervision and Quality Assurance. Cease operations when product quality is at risk. Support other production or compounding-related functions as needed, including: Assisting on packaging lines during bottlenecks or downtime. Cleaning and sanitizing auxiliary equipment, containers, and processing tools. Operating floor scrubbers or other cleaning equipment to maintain facility hygiene.

Requirements

Fluent in reading, writing, and verbal communication in English.
Demonstrated commitment to personal hygiene and cleanliness, in compliance with GMP and FDA OTC regulations.
Strong basic math skills, including weight and volume conversions, percentages, and accurate measurements.
Ability to follow detailed written procedures (Batch Records, SOPs) and verbal instructions without deviation.
Familiarity with calibrated measurement equipment (scales, beakers, graduated cylinders, etc.).
Understanding of and adherence to safety protocols, including handling of cleaning chemicals and operation of production equipment.
Exceptional attention to detail with a proactive approach to identifying discrepancies or non-conformances.
Physically capable of lifting 50–75 lbs and working in environments with exposure to hot water, steam, and chemical cleaning agents.
Basic mechanical aptitude and ability to assist with minor equipment setups or adjustments.
Ability to work independently with minimal supervision and collaboratively as part of a production team.
Ability to wear required PPE throughout the shift, including (but not limited to) eye protection, hearing protection, steel-toe shoes, face shields, aprons, and protective sleeves.
Must be able to wear a fitted full-face respirator or half respirator when required.

Nice To Haves

Operation of OTC pharmaceutical blending/mixing/filling equipment under cGMP.
Ability to assist with basic troubleshooting of compounding equipment.
Strong organizational and multitasking skills across concurrent tasks and priorities.
Clear communication with production, quality, and supervisory personnel.
Ability to maintain complete, accurate, and legible batch documentation and logs.
Commitment to quality, safety, and regulatory compliance in every task.

Responsibilities

Strictly adhere to all current Good Manufacturing Practices (cGMP), FDA 21 CFR Part 211 requirements, company SOPs, and safety protocols to ensure a compliant, safe, and controlled production environment.
Perform and document all cleaning, sanitization, and preparation activities in accordance with approved Batch Records, SOPs, and GDP (Good Documentation Practices).
Immediately report any discrepancies, unclear instructions, or deviations to Compounding Supervision or Engineering for resolution.
Maintain a clean, organized, and audit-ready work area at all times to ensure contamination control and inspection readiness.
Participate in 5S programs and continuous improvement initiatives to support production efficiency, equipment readiness, and workflow standardization.
Provide day-to-day operational support to the Compounding and Production teams, ensuring timely execution of production goals.
Use NetSuite and RFSmart to: Perform inventory transactions including transfers, consumptions, and completions. Verify expiration and retest dates of raw materials before use. Generate and apply appropriate identification labels for traceability and batch compliance.
Assist with setup and staging of equipment such as scales, homogenizers, blending tanks, pumps, and hoses according to batch record instructions.
Record all processing parameters (e.g., weights, volumes, temperatures) in batch documentation with precision and in compliance with GDP.
Perform material charging to blending vessels per batch record instructions, ensuring prevention of cross-contamination or material mix-ups.
Execute line clearance and cleaning procedures between batches (lot-to-lot or full clean), including breakdown and cleaning of all required equipment as per validated procedures.
Safely operate manual and electric pallet jacks to transport raw materials, equipment, stainless steel totes, and production containers within GMP areas.
Demonstrate and promote a Quality First Mindset: Understand critical quality attributes and process parameters associated with compounding operations. Identify and immediately escalate any quality issues to Supervision and Quality Assurance. Cease operations when product quality is at risk.
Support other production or compounding-related functions as needed, including: Assisting on packaging lines during bottlenecks or downtime. Cleaning and sanitizing auxiliary equipment, containers, and processing tools. Operating floor scrubbers or other cleaning equipment to maintain facility hygiene.