Quality Control Lead, Microbiology (3rd Shift)

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