Formulation and Fill Technician II

Job Title:

Formulation & Fill Technician II

Job Grade:

0H

Department:

Manufacturing

FLSA Classification:

Non-Exempt

Manager’s Job Title:

Supervisor, Formulation & Fill

Department Head Title:

VP, Operations

Does This Position Have Any Direct Reports?

No

Job Description Approval Date:

May, 2021

Job Summary

Performs the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment.

Area Of Responsibility

• Formulate and dispense product in a clean room environment for Radio-pharm as well as dermatological products

• Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials, ampoules etc.

• Perform all automatic and manual manufacturing processes as needed

• Perform all required cleaning of manufacturing facility and equipment as needed

• Follow all company policies relating to job safety

• Perform preparation and set-up of glassware and lab equipment to ensure proper conditions for production process 

• Document data and review completed batch records to ensure product is made in accordance with specifications

• Assist in review of SOPs and batch records,  as needed 

• Perform equipment monitoring, under direction, as needed

• Complete all necessary paperwork to conform with FDA regulations

• Other duties as assigned

Work Conditions:

• Office

• Lab

• Controlled areas

• Exposure to syringes and needles

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch or crawl, 

• Talk/hear 

• Close vision, color vision, peripheral vision, depth perception, ability to focus

• Ability to visually inspect small products and print

• Operate lab equipment

• Operate computers/office machines

• Must wear lab coat and other safety attire

• Lift up to 50 lbs. 

Travel Estimate

Up to 0%

Education and Job Qualification 

• High School Diploma or GED required

• Work under direct supervision and follow clearly described procedures

• Education in Life sciences or technical discipline experience preferred

• Good organizational and record keeping skills

• Basic computer skills

• Attention to detail

• Strong verbal, written and interpersonal communication skills 

• Ability to visually inspection small products/print 

Experience

• Minimum of 2 - 5 years related experience preferred

• Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs) preferred

• Basic math, computer, and record keeping skills required

• cGMP training a plus

• Familiarity with aseptic fill/finish, formulation techniques preferred

• Experience working in a controlled environment preferred

• Related experience in pharmaceutical environment preferred