Job Details

Join to apply for the QC Analyst II role at Ageatia Global Solutions

4 months ago Be among the first 25 applicants

Join to apply for the QC Analyst II role at Ageatia Global Solutions

Job Title: QC Analyst II - Hiring Now! 6+ Roles to be filled IMMEDIATELY!

Job Description:

Must have: Attention to detail, Organization skills, Time management

Degree in Biology (Microbiology a plus)

Highly desirable: working knowledge of USP 71

Working knowledge of BacT/Alert

Quality Control Analyst - Microbiology

The purpose of this role is to support the Quality Control, Microbiology Safety Team conducting bioburden, microbial enumeration, endotoxin, sterility testing, and other tests as needed. The individual in this role will support assays associated with QC-Microbiology/EM, assist with OOS investigations, and general upkeep of the microbiology department-controlled areas.

How You Will Do It:

1. Perform USP 61, USP 71, USP 63, USP 85 assays or validated alternatives.
2. Perform growth promotion testing on liquid and agar media, for lot release, as well as for Client & AMT growth promotions.
3. Execute BET (endotoxin) testing using the WinKQCL-1000 platform.
4. Perform and monitor rapid sterility testing using the BacT/Alert platform.
5. Perform microbiological assays for media, raw materials, process intermediates, and final drug product lot release.
6. Assist with maintenance of laboratories, inventory of consumables, and equipment maintenance.
7. Support lab investigations, system suitability failures, OOS excursions, and deviations.
8. Participate in change control actions: revise procedures and draft qualification reports.
9. Maintain compliance with all required training.
10. Perform other duties as assigned.

What We Look For:

1. Associate degree in Life Sciences required.
2. Bachelor's degree in Microbiology or Bacteriology preferred.
3. Working knowledge of Quality Control Microbiology and a cGMP environment.
4. Strong communication skills, proficiency in Microsoft Word and Excel.
5. Experience with bioburden, growth promotion, endotoxin testing, microorganism identification, or sterility testing is a plus.
6. Knowledge of laboratory skills, microbiological assays, and aseptic methods.
7. Experience with WinKQCL, LIMS, SAP, and TrackWise is a plus.
8. Able to propose ideas during problem solving and process improvement.
9. Timely, clear, and accurate communication.
10. Record keeping and maintaining laboratory data.
11. Dependable, team-oriented, and able to represent the department effectively.

Additional Details:

• Seniority level: Entry level
• Employment type: Contract
• Job function: Quality Assurance
• Industries: IT Services and IT Consulting