Lab Technician - GMP
- Education: N/A
- Functional Area: Administrative & Clerical
- Industry: Biotechnology & Pharmaceuticals
The person filling this position operates all equipment in two assigned Manufacturing areas. He or she will also clean equipment and facilities, and provide documentation of all duties in accordance with Good Manufacturing Practices. Incumbent will perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures. The incumbent will be required to attend quality-training programs and orientations on an annual or as needed basis. This individual will be required to become familiar with domestic and international regulatory requirements associated with manufacturing and biological processes. Annual performance goals and objectives will be evaluated against specific quality performance requirements as defined by the Manufacturing Supervisor. Mandatory commitment to report to management any potential or actual deviations from regulatory requirements. Ongoing input regarding quality process improvements. Master documentation procedures by following detailed written and verbal instructions in order to complete assigned tasks (follow area SOP’s). Demonstrate knowledge of procedures by performing tasks and duties and maintaining detailed records in a manner compliant with cGMPs. Perform routine job duties, which may include vacuuming, mopping ceilings, walls and floors, emptying trashcans, etc. Prepare production glassware and other equipment by operating industrial washers, autoclaves and depyrogenation ovens. Clean and sterilize process equipment (tanks, fermentors) as needed. Demonstrate and instruct proper gowning and aseptic processing procedures. Work with individuals as a team. Work various shifts and some weekends. Operate and troubleshoot production equipment in assigned area and report unusual conditions or concerns about the process or equipment to area Supervisor. Train new employees on production processes. Perform lab work, such as: performing sample dilutions, pH, and conductivity readings.
The following combinations of education and work experience are considered acceptable:
• BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience
• AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience
• HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience
• Or progression from Bio-processing Technician Level I. that includes additional internal development curriculum
List certificates (if any) required.
1. Must complete training in assigned area and comply with applicable safety, OSHA, and environmental safety requirements.
2. Must complete training and comply with applicable cGMP requirements.
State type and minimum number of years of prior experience required to perform job duties.
A minimum of four years pharmaceutical experience in biological manufacturing is preferred.
List specific skills and minimum expertise (ie., typing speed (WPM), fully trained ability to learn, etc.) required to perform
1. Moderate repetitive standing, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs) required on a daily basis.
2. Basic understanding of the metric system.
3. Be able to rationalize by suggesting solutions to unusual conditions and/or process concerns.
4. Must possess mechanical ability to assemble and operate equipment.
5. Must pay attention to detail by following procedures and noting unusual conditions.
6. Must have written and oral communication to read procedures, write accurate observations and follow directions
GMP experience required
Pharma experience highly preferred
Bioprocessing experience in a cGMP environment, knowledge of Clean and Steam in Place Systems, perform facility cleanings, collecting WFI and Clean Steam samples. Experience with autoclave and industrial washers.
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- Name: Mukesh Sharma
- Email: email@example.com
- Phone: 9525463300
- Extension: 6003
- Name: Select Source International
- Website: www.selectsourceintl.com