Job Description
Job Description
Shift:
- Shift: 2nd Shift: Sun-Wed. Sun-Tues (3PM-1:30AM), Wed (3PM-11:30PM).
- 6-month contract with potential to extend
Pay: $26.28 - $30.00/hr
Overview:
- This role is responsible for executing fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.
- Executing independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging
- Performing internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
- Executing with oversight of qualified staff fundamental tasks as CIP and SIP of tanks, manufacturing equipment as well as buffer prep and transfer into tanks and bags
- Daily analytics and maintenance of analytical equipment as well as cleaning and setup of equipment.
- Reporting abnormalities and deviations in a timely and accurate manner.
- Documents work according to cGMP and cGDP
Qualifications:
- High School degree Required ; Bachelor’s degree Preferred
- Basic interactions Manufacturing Cell Culture, Manufacturing Purification, Manufacturing Compliance, Engineering & Technology, Supply Chain, Quality Assurance, Quality Control
- Preferable 1 or more years of experience in cGMP regulated industry
- Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards