Job Summary
- Perform daily laboratory testing and sample collection per approved procedures, specifications, and regulatory requirements.
- Conduct sample preparation, execute test methods, accurately document results, and timely report data.
- Support routine laboratory maintenance (e.g., equipment cleaning/basic maintenance, inventory management, waste disposal, and maintaining inspection-ready workspaces).
Essential Functions
Technical Expertise
- Basic understanding of compliance/guidance/regulation for assigned area.
- Perform routine testing and sample collection per written procedures; limited non-routine testing/validation studies with supervisory oversight.
- Perform microbiology/bioassay testing using microbiology techniques, including: Purity/Filtrate/enumeration testing; aseptic technique; animal injections (preferred; SubQ or ID).
Laboratory Support / Quality Systems
- Use LEAN practices (6S+ and Kaizen) for continuous improvement.
- Conduct initial review; review and enter passing results in LIMS.
- Receive, label, and restock reagents and supplies; maintain standard lab equipment.
- Execute and document work orders with facilities/metrology to support GMP-compliant labs/equipment.
- Provide input to SOP/test method revisions; participate in investigations, deviations, CAPA, and Change Control.
Problem Solving
- Handle problems of simple-to-moderate scope using review of identifiable factors and judgment within defined procedures.
Minimum Education, Experience, Skills
- BS in Microbiology (or closely related field) preferred.
- 0β2 yearsβ experience preferred (or equivalent).
- Preferred: microbiology assays and aseptic techniques in a GMP environment.
- Preferred: animal injection experience (SubQ or ID).
- Competencies: self-awareness, integrity, teamwork, innovative, flexible.
- Preferred: understanding of cGMP, CFR, USP, and aseptic processing.
- Required: computer skills (MS Office, MS Project, or comparable tools).
- May require weekends/holidays.
Benefits
- Estimated base salary range: $50,000β$60,500. Comprehensive benefits package offered (details on company site).
Application Instructions
- If selected for interview, speak with an HR Partner about compensation philosophy and benefits.