Aseptic Suspensions Formulation Technician

Paycom; New York (NY); On-site; USD 55,000 - 85,000; Full time

Job summary

Paycom is seeking a Product Formulation Technician-Suspensions to operate compounding equipment and support both Commercial and Development formulation areas. You will ensure documentation and activities comply with applicable regulations and TRC batch records.

The role requires assisting in SOPs, equipment calibration and cleaning, and performing in-process testing with data entry into LIMS. Overtime and rotating 12-hour shifts are expected in a regulated environment.

Qualifications

• High School diploma or GED and 0-2 years in a regulated laboratory environment.
• Knowledge of cGMP guidelines.
• Ability to work rotating 12-hour shifts.

Responsibilities

• Assist the Aseptic Processing Manager in establishing SOPs as needed.
• Satisfy the compounding equipment operation, calibration, and cleaning requirements.
• Keep a clean, safe, productive, and orderly staging, dispensing, and compounding area.
• Assist in sampling and weighing of chemicals required to support product formulation.
• Perform validation methods on the compounding equipment.
• Perform filter testing on sterile filters and maintain logbooks.
• Perform in-process testing and data entry into LIMs.
• Responsible for batch compounding according to TRC Documents and Protocols.
• Responsible for the pre and post cleaning and steaming of the compounding equipment.
• Perform routine maintenance on equipment.
• Assist the Product Development Engineer in developing safe and efficient functional procedures and work instructions in support of new formulation processes.
• Operate equipment in the formulation of new products and new processes to support formulation and equipment studies, and validation activities.
• Perform the sampling of raw materials when necessary and obtaining the tools and instruments required to support operation of the process.
• Formulate GMP Development Batches for Validations, Clinical Distribution and FDA Regulatory filings in compliance with TRC Batch Record instructions, Procedures and Policies.
• Responsible for cross-training with the Dispensing Department.
• Perform additional duties as assigned by management.
• Follow SOPs safety, health and cGMP guidelines.

Education

High School diploma or GED

Tools

LIMS

Job description

Paycom is seeking a Product Formulation Technician-Suspensions to operate compounding equipment and support both Commercial and Development formulation areas. You will ensure documentation and activities comply with applicable regulations and TRC batch records.

The role requires assisting in SOPs, equipment calibration and cleaning, and performing in-process testing with data entry into LIMS. Overtime and rotating 12-hour shifts are expected in a regulated environment.