Summary:
A motivated Quality Control professional experienced in routine microbiological testing sample analysis, and culturing of microorganisms under direct supervision including participation in validation activities. Strong understanding of laboratory documentation, data integrity, and quality systems with a desire to expand technical and regulatory knowledge.
Responsibilities
· Perform routine microbiological testing including bioburden, environmental monitoring, microbial identification, with an automated, rapid optical microbial testing platform according to company procedures.
· Create procedures for equipment operation and laboratory function according to Good Laboratory Practice.
· Accurately document laboratory data in accordance with GMP, GLP, GDP, and ALCOA+ principles. Record test results accurately into notebooks for special lab requests/studies.
· Prepare laboratory media, reagents, standards, and test solutions as needed. Maintain inventory of all media, reagents in support of testing.
· Support investigations of out-of-specification (OOS), out-of-trend (OOT), or laboratory deviations with guidance from senior personnel.
· Participate in equipment qualification, calibration, and routine maintenance activities.
· Review laboratory records for completeness and compliance.
· Follow SOPs, safety procedures, and regulatory requirements.
· Collaborate with Quality Assurance and Manufacturing teams to support product testing and project timelines.
· Prepares and/or Reviews Test Procedures, SOP's, Equipment and Validation Protocols as assigned.
· Notify manager immediately of nonconforming data or unexpected occurrences. Initiate nonconformances, deviations or OOS as necessary
· Assists with incoming raw material inspections related to microbiological testing or other quality related needs.
· Organize a work schedule to complete assigned tasks efficiently and on schedule
· Work under direction provided by quality management and other duties as assigned
Qualifications
Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, or a related scientific discipline.
0–2 years of laboratory experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related industry.
Hands-on experience with microbiological testing techniques. Proficient with basic lab hardware (microscopes, autoclaves, pipettes), strong attention to detail, and basic computer literacy
Knowledge/use of analytical chemistry instrumentation and laboratory testing.
Knowledge or experience with Neogen's Soleris NG platform, preferred.
Familiarity with cGMP, GDP, and Good Laboratory practice documentation practices.
Strong attention to detail, organizational skills, and ability to work effectively in a team environment.
Knowledge of USP microbiological testing requirements.
Experience using other microbiological instrumentation.
Proficiency with Microsoft Office and Master Control.
Familiarity with electronic quality management systems (eQMS).
Location in Milwaukee, WI (100& onsite).
Work Structure: Please note that this role requires a daily, in-person presence at our Milwaukee office. There is no option for remote or hybrid work. Please only apply if you are serious about working onsite daily in the Milwaukee area and meet all location requirements.
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