Qureos Mentor

Formulated Solutions

<div><div><b>PRIMARY PURPOSE:</b></div><div>
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 &mdash; all performed in strict accordance with <b>cGMP</b>, <b>FDA regulations</b>, and <b>internal SOPs</b> to ensure consistent product quality and regulatory compliance.</div><div></div><div><b><br>
MAJOR DUTIES AND RESPONSIBILITIES:</b></div><ul><li><b>
Strictly adhere</b> 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.</li><li><b>
Perform and document</b> all cleaning, sanitization, and preparation activities in accordance with <b>approved Batch Records</b>, <b>SOPs</b>, and <b>GDP (Good Documentation Practices)</b>.<ul><li>
Immediately report any discrepancies, unclear instructions, or deviations to Compounding Supervision or Engineering for resolution.</li></ul></li><li>
Maintain a <b>clean, organized, and audit-ready work area</b> at all times to ensure contamination control and inspection readiness.</li><li>
Participate in <b>5S programs and continuous improvement initiatives</b> to support production efficiency, equipment readiness, and workflow standardization.</li><li>
Provide day-to-day operational support to the <b>Compounding and Production teams</b>, ensuring timely execution of production goals.</li><li>
Use <b>NetSuite and RFSmart </b>to:<ul><li>
Perform inventory transactions including transfers, consumptions, and completions.</li><li>
Verify expiration and retest dates of raw materials before use.</li><li>
Generate and apply appropriate identification labels for traceability and batch compliance.</li></ul></li><li>
Assist with <b>setup and staging</b> of equipment such as scales, homogenizers, blending tanks, pumps, and hoses according to batch record instructions.</li><li>
Record all processing parameters (e.g., weights, volumes, temperatures) in batch documentation with precision and in compliance with GDP.</li><li>
Perform <b>material charging</b> to blending vessels per batch record instructions, ensuring prevention of cross-contamination or material mix-ups.</li><li>
Execute <b>line clearance and cleaning</b> procedures between batches (lot-to-lot or full clean), including breakdown and cleaning of all required equipment as per validated procedures.</li><li>
Safely operate manual and electric pallet jacks to transport raw materials, equipment, stainless steel totes, and production containers within GMP areas.</li><li>
Demonstrate and promote a <b>Quality First Mindset</b>:<ul><li>
Understand critical quality attributes and process parameters associated with compounding operations.</li><li>
Identify and immediately escalate any quality issues to Supervision and Quality Assurance. Cease operations when product quality is at risk.</li></ul></li><li>
Support other production or compounding-related functions as needed, including:<ul><li>
Assisting on packaging lines during bottlenecks or downtime.</li><li>
Cleaning and sanitizing auxiliary equipment, containers, and processing tools.</li><li>
Operating floor scrubbers or other cleaning equipment to maintain facility hygiene.</li></ul></li></ul><div></div><div><br>
 <b>QUALIFICATION:</b></div><div>
 <b>Required:</b></div><ul><li>
Fluent in reading, writing, and verbal communication in English.</li><li>
Demonstrated commitment to personal hygiene and cleanliness, in compliance with <b>GMP and FDA OTC regulations</b>.</li><li>
Strong basic math skills, including weight and volume conversions, percentages, and accurate measurements.</li><li>
Ability to follow detailed written procedures (Batch Records, SOPs) and verbal instructions without deviation.</li><li>
Familiarity with calibrated measurement equipment (scales, beakers, graduated cylinders, etc.).</li><li>
Understanding of and adherence to safety protocols, including handling of cleaning chemicals and operation of production equipment.</li><li>
Exceptional attention to detail with a proactive approach to identifying discrepancies or non-conformances.</li><li>
Physically capable of lifting 50&ndash;75 lbs and working in environments with exposure to hot water, steam, and chemical cleaning agents.</li><li>
Basic mechanical aptitude and ability to assist with minor equipment setups or adjustments.</li><li>
Ability to work independently with minimal supervision and collaboratively as part of a production team.</li><li>
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.</li><li><b>
Must be able to wear a fitted full-face respirator or half respirator when required.</b></li></ul><div></div><div><b><br>
CRITICAL SKILLS AND ABILITIES:</b></div><ul><li>
Operation of OTC pharmaceutical blending/mixing/filling equipment under cGMP.</li><li>
Ability to assist with basic troubleshooting of compounding equipment.</li><li>
Strong organizational and multitasking skills across concurrent tasks and priorities.</li><li>
Clear communication with production, quality, and supervisory personnel.</li><li>
Ability to maintain complete, accurate, and legible batch documentation and logs.</li><li>
Commitment to quality, safety, and regulatory compliance in every task.</li></ul><div></div><div><b><br>
Education and/or Training</b></div><ul><li>High School diploma or equivalent</li></ul></div><p></p>

COMPOUNDER III - 3rd SHIFT

<div><h1 class="jobSectionHeader"><b>PRIMARY PURPOSE:</b></h1><div>
Assume responsibility for and exercise leadership and initiative in all matters affecting Blending operations. Exhibit strong &ldquo;ownership&rdquo; of blending operations using a hands-on approach to management. Demonstrate proactive, positive, &ldquo;can-do&rdquo; leadership by setting an example for subordinates to follow. Plan, organize and manage employees and equipment in order to meet quality/regulatory objectives, production schedules, and cost targets. Blending Supervisor manages daily operations for mixing ingredients, ensuring quality, safety (GMP), and efficiency, leading staff, handling schedules, maintaining equipment, troubleshooting issues, managing inventory (raw materials/chemicals), documenting batches (batch records), and driving process improvements in a GMP-regulated manufacturing environment, often requiring shift work and PPE.</div><p></p><h1 class="jobSectionHeader"><b><br>
MAJOR DUTIES AND RESPONSIBILITIES:</b></h1><div><ul><li>
Assist in developing and implement realistic production schedules. Schedule overtime and/or variations in work schedules in order to meet commitments. Work overtime, split shifts, and weekends as needed. Work before and after shift to prepare, organize and complete blending commitments as required.</li><li>
Openly communicate with subordinates, peers and others to clarify and meet blending goals. Represent company management to subordinates.</li><li>
Understand process and product quality objectives and implement blending systems to maintain regulatory compliance and achieve improvement goals.</li><li>
Enforce all company policies: dress codes, attendance rules, safety procedures, etc ..</li><li>
Foster growth and participation in improving operations by mentoring and developing subordinates.</li><li>
Conduct ongoing and formal employee evaluations providing feedback to employees as required. Implement rewards and discipline/reprimands per company policy.</li><li>
Understand and follow <i>verbal </i>instructions in English.</li><li>
Accurately count production or inventory items and neatly record results.</li><li>
Identify mistakes and immediately bring to the attention of supervision.</li><li>
Read, understand and follow <i>written </i>instructions in English. Notify supervision if instructions appear to be incorrect or cannot be followed. Stop work until resolved or follow supervisory direction.</li><li>
Neatly and accurately record data per FDA Good Documentation Practices.</li><li>
Report on production and quality goals</li><li>
Participate in equipment/process validation studies.</li><li>
Share information and ideas to improve individual and team effectiveness.</li><li>
Cooperate and work with other employees to make an effective team.</li><li>
Set-up lines and work area for blending: Containers, labels, scales, instructions, data collection sheets, etc. Complete batch set-up records.</li><li>
Set-up pumps and motors to pump materials as needed.</li><li>
Operate blending machines and liquid pumps.</li><li>
Monitor and make machine adjustments during operation as required.</li><li>
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.</li><li>
Assist in installation of new machines and equipment.</li><li>
Maintain blending equipment and adjustment/service/repair/ tools in correct location.</li><li>
Clean machines, facilities, equipment and flooring. Pay particular attention to floors to reduce risk of slipping and falling!</li><li>
Follow safety procedures.</li><li>
Resolve safety concerns and/or report to supervisor.</li><li>
Train (or assist in training) others as required.</li><li>
Make work assignments within blending area.</li><li>
Identify and understand quality criteria for task performance.</li><li>
Identify quality problems and stop operating until resolved.</li><li>
Resolve quality issues within blending area or seek support.</li><li>
Control and maintain integrity of material stock quantities. Correctly record material withdrawals/changes on inventory cards and batch records.</li><li>
Potential exists for exposure to potentially harmful chemicals.</li><li>
Document inventory changes per procedure.</li></ul></div><p></p><h1 class="jobSectionHeader"><b><br>
QUALIFICATIONS:</b></h1><div><ul><li><h2 class="jobSectionHeader"><b>
Required</b></h2><ul><li>
Ability to lift 50 &ndash; 75 pounds on a regular basis.</li><li>
Ability to stand for long periods of time on a regular basis.</li><li>
Manufacturing plant (varying conditions, noise), requires PPE (hearing, safety)</li></ul></li><li><h2 class="jobSectionHeader"><b>
Preferred Additional</b></h2><ul><li>
Prior blending/manufacturing experience or equivalent</li><li>
Prior supervisory/management experience</li></ul></li></ul></div><p></p><h1 class="jobSectionHeader"><b><br>
CRITICAL SKILLS AND ABILITIES:</b></h1><div><ul><li>
Ability to operate blending/mixing/filling machinery and related equipment.</li><li>
Ability to train others in effective and safe machine operations.</li><li>
Ability to assist in diagnosis and repair of malfunctioning machines.</li><li>
Ability to organize and control multiple jobs and multiple machines.</li><li>
Ability to communicate effectively with and lead junior personnel.</li><li>
Basic math is required to understand weights, blending/mixing formulas and to track production quantities.</li><li>
Ability to follow written/verbal instructions.</li><li>
Ability to keep accurate records.</li></ul></div><h1 class="jobSectionHeader"><b><br>
COMPUTER SKILLS:</b></h1><div><ul><li>
Microsoft Word, Excel</li><li>
Creating reports and spreadsheets</li><li>
Sending/receiving emails/instant messaging</li></ul></div><p></p><h2 class="jobSectionHeader"><b><br>
Education and/or Training</b></h2><div><ul><li>
High School general math or equivalent.</li><li>
Degree preferred, or equivalent experience</li></ul></div><p></p><p><b><br>
SHIFT: 2nd shift (3:00 pm - 11:30 pm)</b></p></div>

BLENDING SUPERVISOR - 2nd SHIFT

Join Formulated Solutions and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Formulated Solutions

About Company

COMPOUNDER III - 3rd SHIFT

BLENDING SUPERVISOR - 2nd SHIFT