Quality Control Technician III - Microbiology

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

ESSENTIAL FUNCTIONS:

• Perform product bioburden testing on incoming raw materials and finished products
• Perform endotoxin testing by kinetic and gel clot methods
• Write and revise microbiology and other relevant SOP's as required
• Perform laboratory investigations and root cause analysis
• Participate in team meetings
• Rotate holidays and weekends as necessary to support a 24 hour production facility
• Perform microorganism identifications using the Biolog Gen III system
• Perform purified water testing as required by USP
• Perform lab and plant environmental monitoring
• Assist with establishing & maintaining safe work standards in the laboratory
• Follow site HSE Policies
• Peer review all levels of work
• Follow good documentation practices for the accurate and timely documentation of all activities

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• LIMS entry of data
• Use of analytical balance, pH Meter, Biolog Gen III system
• Maintain instrument readiness
• Perform change controls
• Ability to troubleshoot equipment and methods in areas of proficiency
• Mentor and trainer for all areas of proficiency

MINIMUM REQUIREMENTS:

Education:

HS Diploma is required, Bachelor's degree in Biology, Microbiology, Life Science; or Associates degree with applicable experience in Biology, MicroBiology, or Life Science is preferred.

Experience:

Working knowledge of wet chemistry, Aseptic technique, and microbiology testing required. Good technical writing and oral communication skills. Proven application of basic principles, theories and concepts required. 1-3 years of experience in a cGMP facility required. Proficiency in MS Word and Excel. LIMS and BPCS experience preferred.

Preferred Skills/Qualifications:

• 1-3 years of experience in a microbiological function in a pharmaceutical field is a plus.
• Knowledge of environmental monitoring and instrumentation is a plus.
• Good technical writing and oral communication skills
• Can work on moderately difficult or demanding tasks and projects
• Computer literate with experience in MS Office
• Substantial acquaintance with and understanding of application of basic principles, theories and concepts

COMPETENCIES:

Informing, Customer Focus, Listening, Perseverance, Organizing, Functional/Technical Skills, Peer Relationships, Comfort Around Higher Management

ORGANIZATIONAL RELATINSHIP/SCOPE:

Contacts involve matters of moderate importance to the organization and include R&D, Marketing, Production employees including Engineers, Supervisors, and Operators, Logistics, EHS, and DEA.

WORKING CONDITIONS:

• 80% Plant exposure to products, solvents and reagents, some of which are hazardous or potent compounds.
• 20% Office/Laboratory Environment.
• Required to work 8+ hour shifts, the potential for night, weekend, and holiday work depending on the needs of the business.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.