- Works on basic assignments following established Standard Operating Procedures (SOPs),
- Master Batch Records and current Good Manufacturing Practices (cGMPs).
- Performs routine tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating.
- Reports to Team Lead on a regular basis on line performance and report any issues that need to be resolved.
- Performs basic troubleshooting of issues and escalates when required.
- Organizes routine tasks in an effective manner.
- Prepares equipment and components for sterilization.
- Operates processing equipment including autoclaves, ovens, vial washers, and dehydrogenation tunnel.
- Cleans (manually and clean-in-place),
- assembles and disassembles equipment for production.
- Performs clean-in-place and sterilization-in-place of tanks.
- Performs annealing and sterile filtrations of products.
- Operates vial capper, unloads product from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill line.
- Performs Basic Oracle and MES (Manufacturing Execution System) transactions.
- Performs data calculations
- Cleans manufacturing areas, including walls, ceilings and floors.
- Accurately completes required documentation of events and tasks related to assigned work, including logbooks, batch records, etc.
- Reports variance or deviation from standard procedures to department management.
- Prepares coating solution.
- Knowledge of current Good Manufacturing Practices (GMPs).
- Demonstrates good verbal, written, and interpersonal communication skills.
- Receives general instructions on routine work, and detailed instructions on new assignments.
- Follows written Standard Operating Procedures (SOPs) and Master Batch Records and must be able to take variant action only with approval of department management.
- Independent action and initiative in resolving issues.
- Previous experience operating a forklift or powered industrial truck.
- Demonstrates strong safety orientation, with strict adherence to established safety practices and standards.
- Takes independent action and initiative in resolving issues.
- 5+ years of relevant experience, HS Diploma, and a Certificate to FETAC level 6 (GSL)
- Prior experience in a cGMP related industry is required.
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.
Thank you.
Kind Regards,
Harris Kaushik
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # - (650)-399-0891
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
