Quality Control Lead, Microbiology

Reporting to the Supervisor, Microbiology, the Quality Control Lead operates independently to perform biological assays of raw materials, in-process samples, finished product, and environmental monitoring samples. They will represent microbiology leadership on the third shift to ensure that all testing for in-process, finished product, raw materials and stability samples is completed in a timely manner. They will also coordinate with cross-functional teams to support filling and environmental monitoring activities.

### ESSENTIAL DUTIES & RESPONSIBILITIES

• Act as a subject matter expert for microbiology and compliance, supporting deviation investigations, CAPA implementation, and technical audits
• Review and approve microbiological testing records for accuracy and adherence to test methods instrument malfunctions, and methodology problems
• Represent the microbiology department on relevant cross-functional teams to help improve processes throughout the facility
• Perform microbiological assays including sterility, endotoxin, bioburden, AET, biological indicator enumeration and growth promotion testing
• Support routine and fill-related environmental, personnel and utility monitoring
• Assist in the development and implementation of training programs that govern general and microbiological specific laboratory practices
• Lead and participate in continuous improvement projects in the laboratory including 5S and inventory management

### QUALIFICATIONS

• Bachelor’s degree (U.S. or foreign equivalent) in Biology or a related field.
• 5-7 years of pharmaceutical experience

### KNOWLEDGE, SKILLS, & ABILITIES

• Ability to lead, train and mentor analysts in microbiological assays
• Ability to work in a fast-paced environment with minimal supervision
• Able to work flexible schedules at short notice
• Experience with EMPQs and Aseptic Process Simulations
• Familiarity with QMS systems such as Master Control and BMRAM
• Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidance
• Proficient in Microsoft Word, Excel, Outlook, and PowerPoint

### PHYSICAL REQUIREMENTS

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times