What are the responsibilities and job description for the Sterile Production Technician II position at Molecular Pharmagroup?
Sterile Production Technician II
The Sterile Production Technician II is responsible for executing all processes in the production of compounded sterile preparations under pharmacist supervision and/or supervisor. In addition, this person assists in cleaning and maintenance of the work environment.
Responsibilities may include:
● Performs sterile compounding in an ISO classified cGMP environment
● Compounds daily without fingertip growth during manual and semi-automated compounding operations according to master batch records
● Perform setup, preparation, and stocking of clean room and compounding supplies
● Daily, Weekly, and Monthly thorough cleaning of clean room areas and equipment according to SOPs without viable particle growth
● Complete all required documentation adhering to Good Documentation Practices (GDPs)
● Practice good aseptic technique at all times to assure sterility, quality, and integrity of all products
● Complies with FDA 503B guidance, United States Pharmacopeia(USP), cGMPs, and company SOPs
● Demonstrates thorough knowledge of the job, completing all annual competencies and skills validations
● Passes all initial and on-going gowning qualifications and media-fill validations
● With Pharmacist oversight, perform formulation of bulk drug products as needed, in accordance to master batch records and SOPs
● Use of basic laboratory equipment such as glassware washer, autoclave, dry heat oven analytical scales, hotplate/magnetic stirrer, pH/temperature meters, and others
● Perform equipment calibration (i.e., analytical balance, pH meter, particle counter, etc.)
● Assist with product visual inspection, labeling, and processing when needed
● Perform monthly inventory checks
● Immediate notification to Production Management of deviations from established processes or SOPs
● Recognizes priorities and takes action; makes productive use of time
● Other duties as assigned
Experience
Required
● Legally authorized to work in the job posting country
● High school diploma or equivalent
● Must be able to attain 20/20 vision with or without corrective lenses; Specific vision abilities required by this job include close vision, color vision, and the ability to adjust and focus
● Ability to stand upright for several consecutive hours absent of any medical restrictions which could restrict completion of required duties
Preferred
● At least 1 year pharmaceutical manufacturing preferred
● At least 1 year hospital cleanroom experience preferred
● ACPE Sterile Certification preferred
● CPhT Certification preferred
● Knowledgeable in ISO 5/7 environment cleanroom gowning
Job Type: Full-time
Pay: $26.00 - $28.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Paid sick time
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
Experience:
- Pharmacutical Production: 1 year (Preferred)
License/Certification:
- NJ Pharmacy Technician License (Preferred)
Work Location: In person
Salary : $26 - $28