QC Specialist II, Microbiology

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

The QC TechnicianII, Microbiology will be responsible for testing and review of Endotoxin and Microbiology assays for APIs, Intermediates, Raw and Starting Materials and manage the environmental monitoring program as well as the water and critical utilities monitoring program. Other duties include writing, revising and managing QC documentation including lab notebooks, SOPs, STMs and reports and related GMP activities.

Your Tasks:

• Perform Microbiology assays, including USP compendial testing for Bioburden and endotoxin
• Perform necessary environmental monitoring procedures to include water sampling, viable and non-viable air sampling and viable surface monitoring
• General upkeep of microbiology laboratory including monitoring of temperatures for incubators and storage refrigerators
• Perform necessary testing for approval of vendors and qualification of necessary media used in the microbiology laboratory
• Analytical support of the cleaning validation program
• Trend microbiology data and report back to management and QA to ensure systems are within trend
• Write/revise standard operating procedures, and other related GMP documentation as related to the job function as necessary
• Maintain GMP areas to ensure compliance for all requirements for control of materials
• Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
• Operate, maintain and ensure calibration of equipment including, chart recorders, thermometers, analytical balance, pipette and other related equipment in microbiology lab and the GMP facility as required by job function
• Investigate any deviation or out of specification as necessary related to Quality Control work performed as instructed by supervisor
• Follow safety guidelines for handling, disposal and use of chemicals and bacterial waste

Required:

• Bachelor’s Degree in Microbiology Chemistry or related field
• Minimum 4 years’ experience in a GMP environment specializing in pharmaceutical or biotech industry
• Use of analytical techniques / instruments, such as TOC, Endotoxin, Plate Reader, Conductivity, etc., and computer skills
• Experience with Microbiology assays, including USP compendial testing for Bioburden and endotoxin
• Develop and maintain environmental tracking and trending programs
• Knowledge of ICH Q1 and ICH Q7, cGMP and FDA regulations
• Experience working in clean rooms (ISO 7 and/or ISO 8)
• Ability to effectively organize, multitask, and work in a fast-paced environment
• Excellent written and oral communications skills
• Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
• Exhibit professional interpersonal skills
• Communicate effectively and ability to function well in a team environment
• Exhibit detail oriented documentation skills
• Ability to work independently and manage one's time
• Basic computer knowledge, including Microsoft Word and Excel
• Coordinate sampling and testing in collaboration with Quality Control and Production
• Ability to convey to customers and regulatory agencies topics regarding micro-biology processes
• Flexibility of working hours based on business needs, may include some nights and occasional weekends

Preferred:

• Experience with data trending using statistical software