Compounder I

Beauty Manufacturing Solutions Corp•Coppell, TX

6d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Progression 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.

Responsibilities

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.