Job Description

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 RFSmartto:
  • 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.

QUALIFICATION: 

  Required:

• 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. 

CRITICAL SKILLS AND ABILITIES: 

• 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.

Education and/or Training

• High School diploma or equivalent