QC Microbiology Associate 2nd shift

Job Description

Job Description

Position Summary

Responsibilities will vary from performing one procedure or work instruction to a number of analytical, microbiological or quality system procedures for a cGMP sterile facility. Precision and accuracy in performance of the work instructions and data collection is essential. Must be able to maintain laboratory records for process control and comply with quality system and safety requirements. Initial proficiency testing must be passing and competency will be verified periodically thereafter.

Duties and Responsibilities

• Perform sample log-in and ensure samples are appropriately labeled
• Accurately document results
• Environmental monitoring of graded spaces
• Collection and testing of WFI, RODI water and tap water
• Coordination of packing and shipment of samples to contract testing laboratories
• Maintenance and daily verification of laboratory instrumentation
• Maintenance of laboratory supplies
• Maintain storage of samples in accordance with established SOPs
• Maintain regular communication with internal management regarding samples, schedules, customer requirements, problems, delays and/or complaints
• Conduct multiple test steps at once
• Input test result entry into the database and generate reports
• Ability to work unscheduled and overtime hours as needed
• Other duties as assigned

Regulatory Responsibilities

• Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance

Supervisory Responsibilities

• N/A

Experience

• Up to two (2) years of experience working in a cGMP laboratory environment

Education

• Bachelor’s degree in Biology, Microbiology, Chemistry and/or Physical Sciences

Knowledge, Skills & Abilities

• Possess working knowledge of aseptic testing techniques, principles, tools and instruments involved in the sample preparation and performance of microbiological assays
• cGLP
• Perform complex work instructions and/or operate sophisticated equipment under general supervision
• Resolve routine problems
• Experience with Microsoft Office, and general computer proficiency
• Effective communication and availability

Physical Requirements

• Ability to meet gowning requirements
• Ability to remain stationary for prolonged periods of time
• Ability to lift up to 25 lbs. as required
• Satisfactory audio-visual acuity
• Ability to walk between locations
• Fine and gross motor skills to manipulate equipment and tools