Manufacturing Technician

3 weeks ago

Los Alamitos, United States Nivagen Pharmaceuticals Full time

**Manufacturing Technician Job description**

**Summary**:
The Manufacturing Technician will manufacture drug products intended for human use at MedisourceRx. The technician will perform associated tasks in critical and non-critical environments such as equipment operation, cleaning, maintenance, environmental monitoring, and other various tasks relating to the production department. This position reports to the Manufacturing Manager. We are looking for a cleanroom technician with at least couple of years of sterile compounding experience.

**Core Responsibilities**:

- Operate in ISO environments performing essential duties to manufacturing sterile products.
- Routine manufacturing operations including preparation and sterilization of labware, measuring, compounding, filing semi automatically.
- Assist and perform compounding, verifying steps, aseptic processing, container closure, integrity testing, inspecting units for foreign matter, labeling, packaging.
- Complete manufacturing documentation and necessary document control assignments.
- 100% Visual inspection and AQL inspection.
- Competent to perform duties as outlined for material transfer, aseptic processing, and other cleanroom related duties.

**Operations Activities**:

- Perform customer service duties, prepare client orders, etc.
- Stock manufacturing materials and components and perform routine expiry audits on released materials
- Perform cleanroom environmental monitoring, cleaning and disinfection, and sterilization techniques
- Maintain records for manufacturing, environmental monitoring, inspections and cGDP processes
- General maintenance of activities related to facility, production, or warehouse
- Perform manual dexterity activities required to process equipment
- Assist with investigations for compounding reports, audits and/or complaints
- Knowledge of compounding terminology and calculations
- Other duties as assigned by management or quality assurance
- Ability to learn and perform pharmaceutical level visual inspection

**Expertise**:

- Understanding and experience in USP
guidelines and manual aseptic manipulations making sterile compounded products

**Required**:

- Available to work 8-hours shift anytime between 6 am
- 7pm.
- Ability to lift at least 65 pounds and no physical limitation to perform the job of Manufacturing technician.
- Corrected or uncorrected 20/20 vision with no color-blindness, as necessary
- Work in controlled environments and wear personal protective equipment, as necessary.

**Desired**:

- Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211
- Experience participating in a Manufacturing Unit in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals
- Knowledge within the areas of quality control and process validation
- Familiarity and understanding of manufacturing methods related to quality control and sterilization assurance
- Proficient in Microsoft Office: Word, Outlook, Excel, PowerPoint

**Schedule**:
All employees are required to wear a mask, vaccinated and all common areas are cleaned and sanitized at regular intervals.

**Experience**:

- Sterile filling /manufacturing: 1 year (required)

Work Location: One location

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