Compounder

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 means 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.

The Compo under I manufactures basic bulk product batches in accordance with approved master formulas and process instructions, under the direction of a qualified compo under 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.

• 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 compo under 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.

Proficiency requirements for this position are defined in the Compounding Competency Matrix.…