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
