Work Schedule
12 hr shift/nights
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Will work with hazardous/toxic materials
Job Description
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Location/Division Specific Information:
As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization.
How Will You Make an Impact?:
The Senior Formulation Technician will be responsible to produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This colleague follows written and verbal instructions when performing the following duties.
A Day in the Life:
- Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP
- Verify and document production activities in batch records, logbooks and controlled forms
- Complete tasks vital to manufacture drug products in an aseptic filling area, including:
- Cleaning cGMP Areas
- Perform line changeovers
- Parts Preparation
- Filter Integrity Testing
- Operating Parts Washers and Autoclaves
- Performing Tray Loading and Unloading
- Operating the Filling Isolator
- General Material Handling
- Troubleshooting Equipment Alarms
Education:
- High School Diploma or equivalent required
- Associates or Bachelor's degree preferred
Experience:
- Required: Minimum of 2 years of work experience in a manufacturing, operations, production or related field. Pharmaceutical or similar experience preferred.
- Preferred: Experience in a cGMP environment
Equivalency
- Equivalent combinations of education, training, and meaningful work experience may be considered.
Knowledge, Skills, Abilities:
- Excels in a team environment.
- Basic math skills.
- Good verbal/written communication.
- Attention to detail while maintaining a quality product.
- Ability to perform repetitive work duties.
- Ability to follow SOPs.
Physical Requirements / Work Environment
- Work in a clean-room which is a controlled environment for temperature and humidity having low ambient noise.
- Wear gowning which includes: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like.
- Use Personal Protective Equipment (PPE) and understand chemical hygiene.
- Infrequently lift and manipulate up to 25 pounds max unassisted.
- Stand and move about including reaching, bending, stooping, grasping.
- Use hand tools and equipment including forceful gripping, grasping, pushing and pulling.
- Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.