Position Summary
The Compounder II manufactures bulk product batches of all standard types — including emulsions, reverse emulsions, scrubs and washes — in accordance with approved master formulas and process instructions, working independently within the scope of current qualification. The role operates processing equipment for which the incumbent is trained and qualified, assists with the training of new and temporary employees, 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 product batches of all standard types (reverse emulsions, emulsions, scrubs, washes) in accordance with the approved master formula and process instruction, working independently within the scope of current qualification.
- Assist with the training of new and temporary employees, and act as second-person verifier for weights, measures and critical process steps performed by others (21 CFR 211.101(c), 211.188).
- 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 (21 CFR 211.25).
- Verify raw material identity, lot number, expiry or retest date and quantity at charge-in and perform second-person verification of weights and measures (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 in-process checks, interpret the result against specification, and escalate an out-of-specification result before proceeding to the next step.
- Reconcile actual yield to theoretical yield at the required phases and investigate any discrepancy with the Supervisor (21 CFR 211.103).
- 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.
- Initiate 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, and contribute to the resulting investigation and corrective action.
- Maintain efficient compounding operations by troubleshooting routine process problems, adjusting equipment within the limits of the process instruction, and raising maintenance work orders with an accurate fault description.
- Follow all safety rules, wear the prescribed personal protective equipment, hold current lockout/tagout authorized-employee status, 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 III. Performance is reviewed periodically against the measures below; the full Above / At / Below Expectation criteria are maintained in the Compounding KPI Scorecard.
Category | Level II Expectation — Compounder II |
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 II builds on the Compounder I foundation and develops the production, quality, and safety skills required at the Compounder III level. Employees in this role will be evaluated for advancement to Compounder III 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, and to recognize when execution has departed from it.
- Applied mathematics for batch work: percentages, unit conversion, dilution, and yield calculation.
- Competence in emulsification (oil-in-water and water-in-oil), polymer and gum hydration, carbomer neutralization, surfactant systems, and heat-sensitive addition.
- Competence in kettle operation: jacket heating and cooling profiles, ramp and hold control, agitation and rotor-stator homogenization, vacuum and deaeration, bulk transfer and filtration.
- Ability to retrieve and interpret kettle / historian batch data and compare it against the process instruction.
- Ability to perform in-process testing (pH, Brookfield viscosity, specific gravity) and interpret the result against specification.
- Ability to author a factual, complete Notification of Event in ETQ.
- Competence in ERP transactions: material consumption and yield reconciliation.
- 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 II” column of the Compounding Competency Matrix.
Experience Required
- High school education or GED equivalent.
- Previous work in a manufacturing environment.
- 2 years batch blending experience.
- Qualified against the Compounder II column of the Compounding Competency Matrix.
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.