Analyst , QC Microbiology-2nd Shift

Job Summary

The Analyst I, QC Microbiology is responsible for conducting qualitative and quantitative microbial analyses to support environmental monitoring, cGMP manufacturing, drug product stability, and incoming raw material testing. This position supports the Microbiology, Environmental Monitoring, and Utility testing programs on the 2nd shift (2:00 pm–10:30 pm, Monday–Friday).

• Perform microbiological testing procedures per batch records, stability protocols, and raw material requests.
• Achieve gowning and aseptic qualification within 4 months and maintain qualification throughout tenure.
• Support aseptic filling operations up to 50% of working time.
• Conduct environmental monitoring and utility testing of the facility, including during fill operations.
• Operate a biohazard trash autoclave and perform daily equipment checks.
• Stock, clean, and prep the laboratory and equipment daily.
• Report OOS, OOL, or deviations to supervisor promptly.
• Participate in equipment validation, troubleshooting, and proactive issue resolution.
• Write and review SOPs and testing standards as necessary.
• Analyze, interpret, and report data; verify and enter results into the laboratory information management system (LIMS).
• Prepare disinfectant solutions, reagents, and samples for analysis.
• Assist in investigations and related studies.
• Follow Good Documentation and Laboratory Safety Procedures per SOPs.
• Track time worked per project and observe reporting during filling operations.

Education: BS in Microbiology, Biology, or a related field.

Experience: 0–2 years in the pharmaceutical or biotechnology industry with emphasis on aseptic processing, QC microbiology, environmental monitoring, water systems, validation, or manufacturing processes.

Skills:

• Technical competence and ongoing knowledge enhancement in position‑related areas.
• Effective communication, presentation, and meeting facilitation skills.
• Strong planning and organization to prioritize and manage workload efficiently.
• Observance of safety and security procedures; ability to lift up to ~25 lbs.
• Adaptability to major changes in tasks, processes, or workplace culture.
• Stress tolerance, maintaining performance under pressure or ambiguity.

The role requires sustained physical activity, including manual handling and working in a laboratory environment with exposure to biosafety hazards.

$47,077.00 – $70,615.00 per year.

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees. We recruit, hire, train, and promote individuals without regard to race, color, creed, religion, sex (including pregnancy or childbirth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity, protected veteran status, genetic information, or any other protected class, in accordance with applicable federal, state, and local laws and regulations.