Analyst II, QC Microbiology

Resilience•West Chester, OH

1d•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.