Compounder I

About Company

At the heart of what we are, we are a small company that specializes in manufacturing personal care products. While we are much bigger now than what we were 20 years ago or even 5 years ago, our company was built on a belief that being small meant that we had to be faster than our competition, smarter, braver and of course, nicer. We knew that in order to make it, we had to produce products that our customers needed, in time, priced right, and with the highest quality. We knew innovation meant pushing the envelope on design and thinking. Most importantly, we knew that developing relationships meant building a reputation for coming through on promises and standing behind our product. That is who we are today and how we operate every day.

Position Summary

The Compounder I manufactures basic bulk product batches in accordance with approved master formulas and process instructions, under the direction of a qualified compounder or supervisor. The role operates processing equipment for which the incumbent is trained and qualified, works in compliance with current Good Manufacturing Practices for OTC drug products (21 CFR Parts 210 and 211) and for cosmetic products (ISO 22716), and maintains a clean, safe and orderly work environment.

Responsibilities and Essential Duties

• Manufacture basic product batches (scrubs, washes and other surfactant systems) in accordance with the approved master formula and process instruction, under the direction of a qualified compounder or supervisor.
• Operate only the processing equipment for which training and qualification are current and documented.
• Complete and maintain current all assigned cGMP, SOP, safety and equipment-specific training before performing any operation independently (21 CFR 211.25).
• Verify raw material identity, lot number, expiry or retest date and quantity before charge-in, and participate in second-person verification of weights and measures as required by the process instruction (21 CFR 211.101(c)).
• Record all batch, cleaning and equipment data contemporaneously, legibly, accurately and attributably. Correct an entry with a single line through it, initials, date and reason. Do not pre-record, back-date or overwrite any entry.
• Perform and record assigned in-process checks (pH, viscosity, specific gravity, temperature, appearance) and submit samples to Quality Control as directed.
• Perform line clearance and verify equipment and area status labelling before starting a batch.
• Wash, sanitize and set up manufacturing equipment in accordance with the validated cleaning and sanitization procedures, observing clean-hold time limits.
• Stop work immediately, notify the Supervisor or Manager, and support initiation of a Notification of Event (NOE) in ETQ for any deviation from the process instruction, out-of-specification result, equipment failure or suspected product quality defect.
• Follow all safety rules, wear the prescribed personal protective equipment, observe lockout/tagout requirements, recognize and report safety hazards and near misses, and keep the work area clean and orderly.
• Observe personal hygiene and gowning requirements, and report to a supervisor any apparent illness, open lesion, or other health condition that may adversely affect product safety or quality, as required by 21 CFR 211.28.
• Maintain regular and reliable attendance and punctuality in accordance with the Employee Attendance Punctuality Policy.
• Report decisions, problems and questions to the Compounding Supervisor or Compounding Manager.
• Follow and abide by the Company Employee Handbook at all times.
• Perform other related duties or projects as required.

Competency and Performance Expectations

Proficiency requirements for this position are defined in the Compounding Competency Matrix. Qualification against the "Req. competency by level" column of that matrix is a condition of independent operation and consideration for progression to Compounder II. Performance is reviewed periodically against the measures below; the full Above / At / Below Expectation criteria are maintained in the Compounding KPI Scorecard.

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Category

Level I Expectation - Compounder I

Safety

Follows all written safety requirements, GMP, SOPs, and safe work practices, including but not limited to LOTO, E-Stop, and machine guarding requirements, and does not bypass or shortcut safety procedures. Wears required PPE, maintains a safe and clean work area, and promptly reports injuries, near misses, unsafe conditions, and safety concerns.

Quality & Compliance

Performs assigned production activities in accordance with company policies, SOPs, Work Instructions, GMP requirements, and approved specifications. Maintains required documentation and traceability, and completes all required ETQ, company, and job-specific training.

Job Performance

Performs assigned production tasks accurately and demonstrates proficiency on assigned workstations and equipment. Develops the ability to perform assigned tasks independently while meeting established production standards.

Cost

Uses materials, components, equipment, and production time responsibly, and minimizes preventable waste, rework, errors, and material discrepancies.

Reliability & Conduct

Follows the Employee Handbook and company policies, including the Employee Attendance Punctuality Policy. Demonstrates punctuality, teamwork, communication, and professional conduct.

Level Progression - Compounder I is a developmental position designed to build the production, quality, and safety skills required at the Compounder II level. Employees in this role will be evaluated for advancement to Compounder II based on demonstrated competencies, including qualification under the Compounding Competency Matrix and the criteria as well as performance, attendance, adherence to safety standards, and business needs. Advancement decisions are made at the Company's discretion. Advancement is not automatic or guaranteed, and time spent in this position does not alter the at-will nature of employment.

Technical Skills Required

• Ability to read, interpret and execute a written process instruction and batch record in English.
• Basic mathematics - weights, volumes, percentages and unit conversion - sufficient to verify a charge-in quantity.
• Ability to operate a calibrated balance and perform tare, gross and net weighing to the stated tolerance.
• Ability to operate a compounding kettle: water charge, heating and cooling, agitation, and basic bulk transfer.
• Working knowledge of cGMP and good documentation practice (ALCOA+).
• Basic ERP understanding for the transactions this role performs, and use of electronic training records.
• Ability to contribute to a productive and cooperative atmosphere, show commitment to team objectives, handle day-to-day work challenges, and manage multiple tasks at one time.
• Meets every proficiency rating in the "Req. Compounder I" column of the Compounding Competency Matrix.

Experience Required

• High school education or GED equivalent.
• Previous work in a manufacturing environment.
• No prior batch blending experience required. Qualification against the Compounder I column of the Compounding Competency Matrix must be completed within 90 days of hire.

Physical Requirements

• Regularly sit, stand, and walk for extended periods of time.
• Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, and stoop repeatedly.
• Frequently lift, carry and position materials weighing up to 50 pounds, and occasionally up to 75 pounds. Move drums weighing up to 500 pounds using the drum handling equipment and lift assists provided; drums are not manually lifted.
• Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes or airborne particles, wet floors, moving mechanical parts, electrical hazards, chemicals, vibration, and work on elevated platforms.
• Prolonged use of a computer screen.
• Must be able to discern differences in colors and shades.
• Good eye/hand coordination.
• Ability to seize, hold, grasp, turn, or otherwise work with hand or hands.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.