Formulation and Fill Technician II
Billerica, Massachusetts, United States
Job Description
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
Work Conditions:
Physical Requirements:
Travel Estimate
Up to 0%
Education and Job Qualification
Experience
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
Apply
Career Focus: Formulation Development
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