Quality Analyst 1 - Microbiology

Department: Production/Operations

Employment Type: Full Time

Location: Customer Location

Compensation: $24.00 - $28.00 / hour

Description

Key Responsibilities

• Works independently to complete microbiological product release tests by performing testing on the traditional media. 
• Assures compliance to inspection readiness programs within the organization.
• Performs water and particle testing to assure proper environment is maintained.
• Prepares product samples for multiple groups testing needs aseptically.
• Adhere to quality, GLP, GMP and regulatory compliance policies.
• Maintain equipment, reagents, and supplies. Will require limited work in a freezer.
• Completes analysis of data using spreadsheets or LIMS to report testing results. Reviews data for accuracy and completeness.
• Completes Laboratory Investigations
• Perform raw material, intermediates and final product microbiology testing
• Calibrate, troubleshoot and maintain laboratory instrumentation and equipment
• Participate in laboratory investigations, validations and verifications
• May require over-time and occasional C or B shifts based on production needs and schedule. 
• Participates in special projects as assigned.

Skills, Knowledge and Expertise

• 2 years of laboratory experience minimum.
• Must be familiar with aseptic technique for microbiological work. 
• Knowledge of QA and QC principles and tools required.
• Ability to multi-task, adapt to changes in daily workload, and contribute in a cross-functional team setting is desired.
• Knowledge of current good lab practices, applicable GMP is required and familiarity with quality audits is recommended.
• Microsoft Office (Word, Excel, PowerPoint, etc.) tools experience for communications, reporting and data analysis is required.
• Careful attention to detail and accuracy of work is essential. 
• Planning and organization of daily workload, high affinity toward teamwork and demonstrated problem solving using innovative solutions
• Good written and verbal skills are required to draft and review standard operating procedures
• Mathematically inclined to work up chemical calculations for reagent preparation. 
• Some lifting is required, not to exceed 50 pounds. This position requires working in a lab setting which includes wearing personal protective equipment (PPE) and handling human samples.

• An understanding of cGMPs and documentation in a regulated industry and experience in documentation protocols and procedures is a plus. 
• Experience in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is preferred.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Paid time off
• 401(k)