Analyst II, QC Microbiology

Resilience • West Chester, OH

2d • Onsite

About The Position

The Analyst II, QC Microbiology role supports the Microbiology Department by performing quality-related tasks for pharmaceutical products to include documenting and conducting testing on a variety of samples, such as raw materials, in-process and finished products, stability samples, water, gas, and environmental samples.

Requirements

• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Good problem solving skills.

Nice To Haves

• Bachelor’s degree in biology, microbiology, or related discipline.
• At least 2 year of laboratory experience in pharmaceutical industry.
• Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.

Responsibilities

• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Complete required training and may train others.
• Conduct troubleshooting activities.
• Gather, organize, and communicate operational information to others.
• Facilitate team meetings to discuss progress, initiatives, and/or other matters.
• Actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
• Assist with coordinating activities of support groups.
• Identifies trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.
• Demonstrates proficiency on authoring Quality records (Deviations, CAPAs, and Change Controls).
• Identify temporary and permanent fixes to address issues.
• Alert supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures).
• Collect, record, and report metrics.
• Monitor equipment and/or systems for performance and problem indicators.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
• Perform logbook reviews.
• Lead or participate in process improvement activities and teams to meet strategic goals.
• Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
• Interact with regulatory agency individuals during audits and inspections, when necessary.
• Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
• Coordinate qualification activities.
• Perform routine sampling activities on the facility utilities.
• Recommend compliance resolutions to management.

Benefits

• annual cash bonus program
• 401(k) plan with a generous company match
• medical
• dental
• vision
• family building benefits
• life and disability insurance
• paid vacation
• paid holidays
• other paid leaves of absence
• tuition reimbursement
• support for caregiving needs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level