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

Get the Latest Biotech Jobs

August Bioservices is hiring a Quality Control Lead, Microbiology (3rd Shift)

Job Description

Skills & Technologies

Explore Sports Tech Careers

Salary Information

Create a Job Alert

Related Opportunities

Warehouse Associate (2nd Shift & Weekend Shift)

Quality Assurance Lead (3rd & Weekend Shift)

QA Specialist - On the Floor Support (2nd Shift, 3rd Shift, & Weekend Shift)

Product Quality Assurance Supervisor

Director, Operational Excellence

Senior Scientist - Analytical Development